Blog Tag: FDA
According to the FDA, the medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. As Janet Woodcock, M.D., the Acting Commissioner of Food and Drugs, acknowledges in her July 21, 2021 statement:
“the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices.”
Woodcock also explains the steps being taken by the FDA to avoid such shortages in the future. One step includes a request for $21.6 million to fund a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). This funding request is part of the FDA’s request for $97 million to support its core safety programs. Woodcock explains “the funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices.” RSCSPP’s goal is to prevent and mitigate the supply chain issues like those experienced during the pandemic while reducing dependence on foreign medical devices.
Additionally, the FDA is looking to expand its authority to prevent future shortages. The FDA seeks broader authority “to obtain supply disruption notifications for critical devices.” Broader authority has also been requested to require manufacturers to develop and share risk management plans. The FDA plans to work with Congress to ensure the FDA has the resources and authority needed to advance these initiatives.
Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Medical Device?
The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in commerce must happen before the trademark application will register with the USPTO. If your company markets medical devices or related goods that require regulatory approval, the use in commerce requirement presents unique issues.
Typically, use in commerce is established when the goods affiliated with the trademark application are shipped between two states or to a foreign country, and with a label or packaging showing the trademark on the goods. For most industries, use of a trademark “in preparation” of sales will not suffice to satisfy the use in commerce requirement. Additionally, a trademark owner is only given three years to use the mark in commerce and provide evidence of such use after the USPTO determines the application is otherwise ready for registration. If the owner does not submit proof that it has used the mark by the deadline, the application is deemed abandoned. Three years seems like ample time for many trademark owners, but anyone who has needed regulatory approval for a product knows the process can stretch well beyond these three years. How does one deal with this conundrum?
You may think that you should wait to file your trademark application so that you don’t run out the three-year clock. But this may allow competitors to swoop in and file intervening trademark applications. If the USPTO believes your mark is confusingly similar to the mark in a competitors’ prior application or registration, it could prevent you from being able to register your mark.
With few exceptions, the best strategy is to file your trademark application as soon as possible. Fortunately, the law provides an accommodation for trademark registrants with goods and services that require regulatory approval. Legislators recognized the fact that “commerce” varies in different industries. For instance, while some companies can sell products as soon as they are ready for market, others must undergo testing to get a stamp of approval prior to marketing or selling their products. This latter group typically includes medical device companies. These and other devices may require pre-market approval (PMA) or a 510(k) clearance from the U.S. Food and Drug Administration (FDA), which can take many years.
Lawmakers revised the definition of “use in commerce” to state that such requirement:
be interpreted to mean commercial use which is typical in a particular industry. Additionally, the definition should be interpreted with flexibility so as to encompass various genuine, but less traditional, trademark uses, such as those made in test markets, infrequent sales of large or expensive items, or ongoing shipments of a new drug to clinical investigators by a company awaiting FDA approval (Senate Judiciary Committee Report on S. 1883, S. Rep. No. 100-515, p. 44-45 (Sept. 15, 1988))
This expanded meaning of “use in commerce” has been generally adopted by the USPTO and the courts.
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.” According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”
Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices. The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.” The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).” The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.” The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”
This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.” Some of the questions listed on the article’s checklist include the following:
- Is it a change to the manufacturer’s own device?
- Are performance data needed to evaluate the change?
- Is there a well-established method to evaluate the change?
- Can the data be reviewed in a summary or risk analysis format?
The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.” The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.” The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”
A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here. The FDA currently states that comments on either guidance may be submitted at any time. Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.
Recently, the U.S. Food & Drug Administration (FDA) announced plans to modernize FDA’s 510(k) clearance pathway, which was adopted more than 40 years ago. The FDA stated that the plans are aimed at continuing to ensure that new and existing devices meet their standard for safety and effectiveness as technology rapidly advances.
The FDA announcement reflects its focus on innovation by driving innovators toward reliance on more modern predicate devices. Under the current framework, medical device manufacturers are required to submit a premarket notification to demonstrate that the low- to moderate-risk device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (“predicate device”) that is not subject to Premarket Approval. According to the announcement, nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old, contrary to the Agency’s belief that newer devices should be compared to the benefits and risks of more modern technology.
The Agency announced that it is considering, in the next few months, publishing on CDRH’s website those devices that have been cleared on the basis of demonstrated substantial equivalence of predicate devices that are more than 10 years old. The Agency also said that they are developing proposals to potentially subset certain older predicates and promote the use of more modern predicates. Following up on the announcement, FDA Commissioner Scott Gottlieb, M.D., stated,
As devices become increasingly complex, it’s important that they meet the latest standards for cybersecurity, interoperability, biocompatibility and usability engineering. The FDA has recently advanced policies on these issues, and we know that older predicates often don’t meet our more recent expectations.
Even though the announcement lacks details on these proposals, according to the announcement, in early 2019, the FDA intends to finalize guidance establishing an alternative 510(k) pathway that allows manufacturers of certain well understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.
The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid. According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user.
Malvina Eydelman, M.D., the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA’s Center for Devices and Radiologic Health commented:
“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”
According to the press release, clinical studies found the self-fitting Bose Hearing Aid to yield comparable outcomes relative to those found using a professional fitting. The press release also reported that users generally preferred self-adjusted settings over those selected by a professional.
In a statement made to TechCrunch, Joanne Berhiaume, a spokesperson for Bose, stated:
“Now, the De Novo grant by the FDA validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids but don’t use them.”
The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.”
The agreement formalizes a long-standing relationship by developing a new framework for greater coordination and cooperation. As part of the new framework, specific responsibilities have been assigned to the FDA and the National Protection and Programs Directorate (NPPD), a component of the DHS. The following table provides a breakdown of the responsibilities outlined in the agreement:
|FDA Responsibilities||NPPD Responsibilities|
|1. Coordinate and participate in regular, ad hoc, and emergency coordination calls to enhance mutual awareness of vulnerabilities and threats||1. Serve as central medical device vulnerability coordination center|
|2. Provide NPPD with draft public releases to facilitate coordination of messaging||2. Participate in regular, ad hoc, and emergency coordination calls with FDA to enhance mutual awareness of vulnerabilities and threats|
|3. Comment in a timely manner on NPPD draft advisories and alerts||3. Confer with entities providing sensitive information prior to sharing any CCI, trade secret, or PCII-protected vulnerability or product information with the FDA|
|4. Assess the risk to health and patient harm when potential impact is disputed||4. Coordinate with FDA on the content of alerts and advisories to be published by DHS|
|5. Submit requests to NPPD for independent third-party technical assistance to analyze and test medical systems||5. Maintain technical capabilities to support requests for independent third-party analysis regarding the impact of vulnerabilities|
|6. Share non-trade secret information to resolve disputes of risk, impacts, and communication||6. Publish healthcare and public health related alerts and advisories|
In summary, the DHS will serve as the central coordination center and interface with appropriate stakeholders, and the FDA will provide technical and clinical expertise regarding medical devices.
FDA Commissioner Scott Gottlieb, M.D., during his discussion of the new agreement, addressed the FDA’s continued commitment to confront cybersecurity risk, while also recognizing the need for increased coordination between government agencies:
The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns . . . But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important.
This agreement is not the first time a government agency has reached out to the FDA in an effort to strengthen medical device cybersecurity. As previously reported on the KnobbeMedical blog, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General recommended earlier this year that the FDA include cybersecurity review as a greater part of the premarket review process for medical devices (e.g., through the inclusion of a Refuse-To-Accept checklists). This new FDA-DHS agreement is another example of continuing attempts to address ongoing medical device cybersecurity risks.
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.
According to Gottlieb, clinical trials “are becoming more costly and complex to administer” while “new technologies and sources of data and analysis make better approaches possible.” In order to take advantage of these better approaches, Gottlieb pointed to the FDA’s Breakthrough Devices Draft Guidance, which proposes streamlined procedures to develop flexible clinical trial designs for important medical devices. This will allow the FDA to “evaluate . . . innovative devices more efficiently.” Six breakthrough devices have already been cleared using this program.
Additionally, Gottlieb discussed the FDA’s new goal of enabling the use of “real-world evidence” to support decisions to approve devices. According to Gottlieb, “[r]eal world evidence can help answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials.” The FDA is helping to design several proof-of-concept trials that utilize real-world evidence.
Finally, Gottlieb discussed the FDA’s role in dealing with new and emerging technologies. In particular, Gottlieb discussed artificial intelligence, which “holds enormous promise for the future of medicine.” Medical artificial intelligence models are currently in development and the FDA recently approved an AI algorithm for detection and treatment of distal radius fractures. According to Gottlieb, the FDA is exploring ways to handle and evaluate the kinds of data that are relevant to AI performance and safety, hoping to “enable a transparent benchmarking system for AI algorithm’s performance.”
Gottlieb concludes that the FDA has “undertaken a comprehensive effort to make sure that our organization and policies are as modern as the technologies we’re being asked to evaluate, and that we’re able to efficiently advance safe, effective new innovations.”
According to the press release, the BrainsWay Deep TMS system was previously cleared for treatment-resistant major depressive disorder in 2013, and this month’s de novo clearance is the second indication granted for the device, and marks the first clearance of a non-invasive device for treatment of OCD. The BrainsWay press release further notes that the Deep TMS system’s H7-coil targets the anterior cingulate cortex, which is known to play a role in the pathophysiology of OCD. BrainsWay stated that Deep TMS treatment, which uses changing magnetic fields to stimulate nerve cells in the brain, is non-invasive and has been shown to be safe and well-tolerated by patients.
BrainsWay plans to offer its OCD treatment both in new installations and as an upgrade to its existing systems. Addressing the broad future applicability of the Deep TMS system, BrainsWay president and CEO Yaacov Michlin said:
This clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi center studies and regulatory approvals.
The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors. According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.
Food Allergy & Research reports that as many as 15 million people in the U.S. have food allergies, which results in about 200,000 needing emergency medical care per year. Commenting on the approval, U.S. FDA Commissioner Scott Gottlieb stated:
This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.
Analyst reports indicate wholesalers are not expecting to receive the generic epinephrine autoinjectors from Teva for several months. A Teva spokesperson commented that the company “is applying its full resources to this important launch in the coming months and is eager to being supplying the market.” Currently, Mylan’s EpiPen® 0.3 mg autoinjector 2-pack sells for about $697 at HealthWarehouse.com. Teva has not yet indicated the price of its generic autoinjector.
In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.
The FDA has been ramping up its cybersecurity review lately to deal with increased cybersecurity concerns. For example, a ransomware attack caused an Indiana hospital to shut down its system. Other cyberattacks may have gone undetected.
Currently, the FDA reviews documentation that manufacturers submit regarding cybersecurity as part of the premarket submissions. The FDA uses this information to consider known cybersecurity risks and threats when reviewing submissions that deal with networked medical devices. The FDA may request additional information from applicants when submissions require clarification or when cybersecurity documentation is lacking. In view of these requests, the FDA regularly approves manufacturers on cybersecurity issues when sufficient documentation is provided.
For example, in one review of a glucose monitoring system, an FDA reviewer did not find “any information on how the manufacturer included cybersecurity in the device’s design,” according to the report. “The FDA reviewer explained that the device relied heavily on users to protect against cybersecurity threats by using antivirus software and enabling firewalls. The FDA reviewer requested that the manufacturer update its hazard analysis to address the missing information. The manufacturer did so, and FDA found the update to be acceptable.”
Because of examples like this, the report suggests using cybersecurity documentation as an element in the FDA’s RTA checklist. The RTA checklist is a screen against incomplete applications. Were cybersecurity part of these checklists, failure by a manufacturer to provide adequate cybersecurity documentation could prevent the FDA to accept the submission for substantive review.
The report also suggests that the FDA use presubmission meetings to address cybersecurity-related questions. These meetings serve as a way for manufacturers to ask the FDA specific questions, such as whether the submission satisfies the FDA’s standards. During these meetings, the FDA can include cybersecurity as part of the discussion, which may reduce the amount of time for the FDA review.
Finally, the report recommended that cybersecurity be a stand-alone element in the FDA’s Smart template. A dedicated section on cybersecurity could allow FDA reviewers to explain the results of their review regarding cybersecurity in a standard format.
The FDA has agreed with these recommendations and has begun taking steps to implement them, such as by including cybersecurity in the Smart template. The FDA also said that it “intends to update the RTA checklist and the accompanying guidance to specifically identify cybersecurity as an item in the checklist during the next update of these items.” The FDA is also currently considering new rules that may require submission of software as part of a premarket submission.
On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy designation is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments. A therapy that receives Breakthrough Therapy designation will be reviewed within 60 days of receipt.
Dthera Sciences chief executive officer Edward Cox stated:
We commend the FDA for recognizing this significant unmet medical need as well as the critical importance of providing innovative new treatments to patients with Alzheimer’s and their caregivers.
According to Dthera Sciences, the therapeutic device, termed DTHR-ALZ, is a prescription digital therapeutic for patients with Alzheimer’s disease. The device digitally delivers ReminX, a reminiscence therapy, to patients with Alzheimer’s disease and automatically optimizes the therapy using biofeedback. Reminiscence therapy is a behavioral intervention that involves introduction of familiar pictures, music, or other materials to help patients reminisce about past experiences.
According to the press release, Alzheimer’s disease is a neurodegenerative disease that is among the ten leading causes of death in the United States. In addition, it is one of the most financially costly diseases. According to Dthera Sciences, DTHR-ALZ mitigates the symptoms of agitation and depression associated with Alzheimer’s disease with minimal investment of time and resources.
The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse. With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA intends to encourage development of medical devices that will help to combat the ongoing opioid crisis.
According to the announcement, diagnostic and therapeutic devices at any stage of development are eligible for submission to the Challenge. The FDA also indicates that currently marketed devices may be submitted if developers are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain. Non-limiting examples of suitable medical devices provided by the FDA include diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or opioid-replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.
According to the announcement, Challenge submissions should describe:
- The novelty of the medical device/concept,
- The development plan for the medical device,
- The development team, and
- The anticipated benefit of the device used by patients and the impact on public health as compared to other available alternatives.
The FDA has indicated that they will work directly with selected applicants during a collaboration phase to accelerate the development and review of new devices, similar to the process under the existing Breakthrough Devices Program. The announcement also reports that selected devices will also be granted Breakthrough Device designation without requiring a separate application. Challenge applications will be accepted through September 30, 2018. The FDA will be hosting a webinar on July 25, 2018 to provide further information.
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently being launched in Europe and is expected to be launched in the United States before the end of July 2018.
DBS therapy involves the delivery of electrical stimulation to specific areas of the brain using a surgically-implanted device. About 125,000 Medtronic Activa devices are implanted globally. Medtronic’s Activa DBS system is used as therapy for neurological diseases including Dystonia and Parkinson’s disease.
The Activa Programming Application is designed for use with the Samsung Galaxy Tab S2 tablet. According to Medtronic’s press release, the purpose of the application is to “enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients.” The programmer is expected to have an immediate impact on thousands of patients’ post-implant care. For example, the programmer will allow the service life of certain Activa rechargeable implantable neurostimulators to be extended by 6 years, giving patients about 15 years between device replacement surgeries.
Dr. Mohammad Maarouf, associate professor, head of the Department of Stereotaxy and Functional Neurosurgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Germany stated that the programmer’s “intuitive, visual interface and task-based workflow makes daily use easier, saving [him] time to focus on what’s most important-[his] patients.”
According to Medtronic’s press release, Medtronic’s DBS Clinician Programmer is also approved for use with the Activa DBS systems for treating refractory epilepsy, which will be launched in the United States later this year.
On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”
FDA Commissioner Scott Gottlieb stated that “[m]edical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis.” Medical devices can be used to address opioid addiction by, for example, effectively addressing local pain syndromes in order to supplant the use of systemic opioids and reduce the use of opioids. “New digital technology products and diagnostic tests could help in the opioid addiction fight by detecting, treating, and preventing addiction; addressing diversion of the opioid supply chain to illicit use; and treating pain,” the FDA said.
According to Bloomberg, “accepted companies will get to work more closely with the FDA’s review offices than usual to help get their products approved. Products that qualify as breakthrough devices under food and drug law will receive that designation without the sponsor needing to submit an application, the agency said. A breakthrough device designation can reduce the time and cost to get a product to market that addresses life-threatening or irreversibly debilitating diseases.”
The innovation challenge is open to any product in any stage of development. The challenge also is open to developers of currently marketed devices who can show that their devices have an improved benefit-risk profile compared to opioid use in pain management. The FDA anticipates “that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.”
This innovation challenge is part of the FDA’s plan to aid in the opioid crisis and supports several overarching goals of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. On April 20, 2018, the agency also released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.
The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.
With the precertification program, the FDA hopes to streamline the certification of “mobile apps” and other software that is used to “treat, diagnose, cure, mitigate, or prevent disease or other conditions,” or so-called software as a medical device (SaMD), according to the updated program description. While software in a medical device (SiMD) is not currently part of the program, the FDA hopes to include SiMD and software that is an accessory to hardware in the future. The program will allow certain organizations that can demonstrate a “culture of quality and organizational excellence” to streamline their oversight of SaMD.
The update clarifies that not all software is subject to regulatory review even if it has some connection to the medical industry. In particular, the update notes that non-device software is exempt, such as software that is intended for (1) for administrative support, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, (4) for transferring, storing, converting formats, or for displaying data, or (5) to provide certain limited clinical decision support.
According to the update, organizations “of all sizes” can qualify. The FDA makes clear that startups and smaller companies can apply and receive precertification. Two levels of precertification exist. Level 1 precertification allows an organization to develop and market “lower risk” software without review while also streamlining review of higher risk software. This level would be awarded to an organization that demonstrates excellence in product development but may have a “limited track record” in “developing, delivering, and maintaining” products in the healthcare market. Level 2 precertification allows “lower and moderate risk” software to be developed and marketed without review and allowing streamlined review of other software. This level is awarded to those organizations with a track record in demonstrating high quality software products.
In determining what amount of review is required for “lower risk” and “moderate risk” SaMD, the FDA looks at (1) the risk category of the product, (2) the level of precertification of the organization, and (3) the extent of the changes the software relative to an existing device. Under either level of precertification, “minor changes” require no review by the FDA.
The FDA is looking to update additional aspects of the precertification program, including how it relates to substantially equivalent device review. The FDA is currently requesting comments on the program.
According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the “first artificial intelligence triage software” and its approval begins “a new era of intelligent stroke care begins as regulatory approval.” The Viz.AI LVO Stroke Platform, according to the U.S. Food and Drug Administration press release, is a clinical support software designed to analyze Computerized Tomography (CT) scans, identify suspected large vessel blockage, and send a notification to specialist of a potential stroke in patients sooner.
According to the Centers for Disease Control and Prevention, strokes are the fifth leading cause of death in America. A stroke occurs when the blood vessels in the brain are damaged, compromising the necessary blood flow to the brain. There are many types of strokes and can often lead to brain damage, long term disability, and death. A CT scan can show the location and extent of the damage to the brain to diagnose the stroke as well as the type of stroke that has occurred.
Viz.AI is a healthcare company based in San Francisco and Tel Aviv, dedicated to “expand Direct-to Intervention care” which “advances information about treatable patients straight to the interventionalist.” Neurosurgeon and CEO of Viz.Al, Dr. Chris Mansi stated in a press release:
“The Viz.ai LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients.”
According to the FDA press release, Viz. AI Contact application was granted De Novo premarket review, which is a “regulatory pathway for new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.” This is a new regulatory classification, “which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”
The Viz.AI Contact application is one example of what the FDA calls “clinical decision support software (CDS). CDS includes technology that aids in diagnosing and identifying treatment plans. CDS includes “technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making.” The FDA is currently creating a regulatory framework for CDS to provide guidance and encourage developers in this field.
According to Robert Ochs, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “(This) software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke.”
The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved test is the first direct-to-consumer test to report on three specific BRCA1 and BRCA2 breast cancer gene mutations.
According to the news release, BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. Mutations of these genes may interfere with the production or functioning of the proteins and are linked to an increased risk of female breast and ovarian cancers. About 12% of women in the U.S. population will develop breast cancer sometime during their lives. However, according to the National Cancer Institute, a recent large study estimated that about 72% of women who inherit a harmful BRCA1 mutation will develop breast cancer by the age of 80. Similarly, about 69% of women who inherit a harmful BRCA2 mutation will develop breast cancer by age 80. Because mutations of the BRCA1 and BRCA2 genes may be passed down to future generations, genetic testing for breast cancer risk has become more common.
23andMe offers genetic testing directly to consumers. Traditionally, genetic testing was only available through healthcare providers: an individual would request tests from a healthcare provider, the healthcare provider would order tests from a laboratory, collect and send the samples, and interpret the test results before passing them onto the individual. In contrast, direct-to-consumer genetic testing allows consumers to order and perform genetic tests without needing to interact with a healthcare professional. 23andMe has previously offered direct-to-consumer tests for the purposes of discovering an individual’s ancestry. However, this new FDA approval indicates expansion of genetic testing services to other applications.
Although the FDA approval of 23andMe’s test is positive, the FDA expressly noted certain caveats regarding the test. Specifically, the FDA clarified that the test only detects three out of more than 1,000 known BRCA mutations and that only a small percentage of Americans carry one of the three mutations. A negative result therefore does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. Additionally, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in assuring the test’s accuracy and performance. Though this test may be a precursor for exciting possibilities on the horizon, the FDA warned that this limited test should not completely replace consultations with a health care professional.
The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.
According to Banyan Biomarkers, more than 90 percent of patients presenting to the emergency department with mTBI receive a negative CT scan. Banyan BTI purports to identify two brain-specific protein biomarkers that rapidly appear in the blood after a brain injury, providing information to assess patients with suspected mTBI. According to the FDA, availability of a blood test for concussions will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
With respect to approval of Banyan BTI, FDA Commissioner Scott Gottlieb, M.D. stated:
“A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”
The FDA recently cleared Prescient Surgical’s CleanCisionTM Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to prevent surgical site infection. According to Prescient Surgical, CleanCisionTM is “a novel, first-in-class, advanced intraoperative infection control system” that utilizes an active cleansing technology.
Traditionally, practices for preventing surgical site infections (SSIs) involve administering drugs, controlling patient’s blood glucose level, maintaining optimal temperature and tissue oxygenation, using skin prep agents, and using plastic wound protectors.
The press release states that unlike traditional methods, ClearCision combines wound protection and wound cleansing. Retractable plastic sleeves protect the wound while providing direct access to the surgical site. Irrigation system continuously cleans the wound edge using sterile irrigant solution and removes contaminant using suction. Insoo Suh, cofounder of Prescient Surgical, noted that ClearCision is “a proactive approach to clearing contamination during surgery.”
The press release also notes that SSIs can be caused by bacteria entering the surgical incision site, and lead to significant financial burdens on teh healthcare system.
Jonathan Coe, cofounder, president, and CEO of Prescient Surgical, said in the press release that the company is “initially focusing on abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of [SSI] is high and the need is acute.”
The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for dangerous seizures, including grand mal or generalized tonic-clonic seizures. These seizures cause loss of consciousness and can cause a state of confusion in patients for periods of time after they finish. Embrace is said to allow medical professionals to gain information about when seizures happen with higher accuracy than was previously available and can also alert caregivers when patients are having seizures. During a seizure, the watch vibrates, LEDs light up, and an alert is sent via Bluetooth to the patient’s smartphone. An app on the phone can then send a distress signal via text or phone call to one or more caregivers.
The device was previously approved by the European Medical Agency in April 2017. According to articles, the technology was originally developed at MIT in 2007 and was funded by a successful crowdfunding campaign in 2014, which netted the maker, Empatica, more than $800,000. Embrace went on sale shortly after that campaign and has been available commercially but was not previously available as a medical device in the U.S.
The FDA’s approval was reportedly based on a clinical trial of 135 patients over 272 days. Each of the patients had epilepsy and were simultaneously monitored by EEG and using Embrace. The trial recorded over 6500 hours of data, including 40 seizures, which Embrace detected with 100% accuracy.
Matteo Lai, Co-Founder and CEO of Empatica, touted Embrace’s design and functionality, saying “We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product.” Embrace is said to be the first smart watch to be approved by the FDA for neurological monitoring.