Blog Tag: FDA Approval
(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of smallpox. The U.S., Canada, and Europe have approved an oral formulation for treating smallpox, and Europe has also approved it for treating monkeypox and cowpox. The newly approved intravenous formulation provides an option for patients who are unable to swallow.
The approval is welcome news as over 100 cases of monkeypox have been identified outside its endemic area. Australia, Belgium, France, the U.K., Sweden, Italy, Spain, Portugal, Canada, and the United States have reported cases. The World Health Organization (WHO) warns more cases are likely.
Monkeypox is endemic to Central and West Africa and belongs to a subset of the Poxviridae virus family, which includes smallpox and cowpox. Monkeypox symptoms (fever, sweating, headaches, enlarged lymph nodes) are generally much milder than smallpox. The infection generally spreads from animal to human. However, it can also be transmitted between humans. This can occur through contact with bodily fluids, lesions on the skin or on internal mucosal surfaces, such as in the mouth or throat, respiratory droplets, and contaminated objects.
TPOXX is the first antipoxviral drug approved in the United States.
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 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.
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.
Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.
The Eversense ® CGM system includes an implantable glucose sensor, a wearable transmitter, and the Eversense Mobile App. Senseonics advertises the sensor as utilizing fluorescent, glucose indicating polymer technology to measure glucose in the interstitial fluid. According to Senseonics, measurements from the sensor are conveyed to the wearable transmitter, which wirelessly communicates with the Eversense Mobile App to display real-time glucose measurements, trends, and alerts.
Commenting on the FDA approval, Senseonics President and CEO Tim Goodnow stated:
“With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way.”
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 Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine technology company.
According to the press release, Tc-99m is a diagnostic agent used in more than 40,000 imaging procedures daily for diagnosis and treatment of patients. Prior to approval of the RadioGenix™ System, Tc-99m could only be produced from enriched uranium in facilities outside of the United States that relied on a complicated and potentially unreliable supply of stable uranium radioisotopes. The development of the RadioGenix™ System alleviates these vulnerabilities by providing a reliable domestic source of Tc-99m.
This radioisotope is vital to disease detection, yet health care professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages. Today’s approval has been the result of years of coordination across the FDA and with U.S. government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m – in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine.
According to NorthStar, the RadioGenix™ System is the first and only device for producing a non-uranium Tc-99m. Rather than uranium, the system uses molybdenite, a naturally occurring molybdenum found in the earth’s crust, as the starting material. Major applications of Tc-99m include detection of potential diseases like coronary artery disease and cancer, as well as evaluating lung, liver, kidney, and brain function.
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. The glucose monitoring tool will allow patients to monitor their glucose levels the without painful and inconvenient finger pricks of traditional glucose monitoring.
According to an Abbott press release, the FreeStyle Libre system will allow patients to self-apply the sensor (which is about the size of two stacked quarters) to the back of the upper arm and capture real-time glucose readings with painless scans of a small hand-held reader over the scanner. This is in contrast to traditional blood glucose monitoring, which may require some patients to finger stick up to 12 times per day.
According to the Centers for Disease Control and Prevention, over 29 million Americans have diabetes. The FreeStyle Libre system, which became available by prescription from most retail pharmacies in the U.S. by the end of 2017, should enable patients to better manage their disease. Healthline reports that the product has been available for several to patients in other areas of the world. Dr. Maria Tulpan of Lenox Hill Hospital in New York, NY commented:
What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.
Abbott states that the FreeStyle Libre Flash Glucose Monitoring System is based on proprietary technology and lists over 50 U.S. Patents issued to Abbott Diabetes Care, Inc., that is believes are associated with the device. Representative examples include U.S. Patent Nos. 8,889,305, 9,000,929, and 9,014,774.
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.
According to Commissioner Gottlieb, the FDA regulatory processes for medical devices have remained relatively unchanged for over 40 years. Under a commonly used clearance pathway, device manufacturers are required to submit a Premarket Notification, known as a 510(k). The 510(k) constitutes a premarketing submission demonstrating substantial equivalence of a new device to a similar, legally marketed “predicate” device. The FDA explains that the submission allows the FDA to determine whether the device is as safe and effective as an equivalent device already placed into one of the three FDA classification categories.
However, Commissioner Gottlieb believes that “there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies, and how we must evaluate those technologies.” Similarly, he states that the current 510(k) requirements fail “to realize the full potential of the FDA’s consensus standards program, which was established through the Food and Drug Administration Modernization Act of 1997, and will be refined and expanded as a result of provisions in the 21st Century Cures Act of 2016.” To address these shortcomings, the FDA plans to offer an alternative pathway for demonstrating substantial equivalence in a 510(k) submission.
Under the new pathway, Commissioner Gottlieb states that manufacturers could obtain clearance without direct comparison testing to a predicate device. Instead, substantial equivalence could be established by meeting objective safety and performance criteria, including FDA-recognized standards, FDA-developed guidance documents, or a combination of the two. The pathway would only be available for pre-specified categories of mature devices – those for which safety and performance criteria that meet or exceed the performance of existing, legally marketed devices can be identified.
Commissioner Gottlieb believes that this alternative pathway:
[H]olds tremendous promise to further streamline device review for sponsors and FDA and allow new innovations to get to patients more quickly; to allow more advanced technologies to be efficiently incorporated into new devices; and to foster greater confidence in the FDA’s ability to efficiently evaluate safety and benefits of technologies cleared under this pathway – all while maintaining the same gold standard that we apply to existing review processes.
The FDA will release its draft guidance on the new 510(K) pathway in the first quarter of 2018.
The reSET® mobile app, developed by Pear Therapeutics, is approved to assist individuals undergoing outpatient therapy for alcohol, cocaine, marijuana, and stimulant addictions. The application is not intended for use in treating opioid dependence, however.
The reSET® application is designed to provide a form of treatment called cognitive behavioral therapy. It teaches SUD patients practical skills that help them abstain from using drugs and stick with their rehab programs, and provides a series of reward-based incentives. reSET® is not approved as a standalone treatment. Instead, it is designed to be used in conjunction with outpatient addiction therapy.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to improve outcomes, including abstinence, for patients with substance use disorder.”
reSET® was reviewed through the FDA’s de novo premarket review pathway, a regulatory scheme for low- to moderate-risk devices for which there is no legally marketed predicate to which the device can claim substantial equivalence. The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients. In this trial, patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET® demonstrated statistically significant greater adherence to abstinence (40.3 percent) compared to patients not using reSET® (17.6 percent).
We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas.
Regulatory approval of reSET® may represent an important step forward in the use of mobile applications to treat people with psychological, neurological and substance abuse disorders.
The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to submit a report within 30 days of a problem. Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months instead. Additionally, these reports will be able to “summarize previously reported product malfunctions, rather than filing detailed reports on each case” as reported by the StarTribune. However, this does not affect the 30-day reporting requirement for medical device companies to report “adverse events” or anything that result in actual injury to consumers.
This measure is part of a piece of legislation that must be renewed every five years and which sets the fees that device makers pay the FDA to review their products. The goal of the agreement from the device maker’s perspective is to reduce the time it takes for the FDA to review products and get them to market. According to the New York Times, this bill “compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever.” But this may not be in patients’ best interest, because medical device malfunctions are already “vastly underreported” as acknowledged by the FDA.
StarTribune reports that proponents of the change say that it would “simplify the needlessly repetitive process of reporting known product problems.” Minneapolis-based med-tech regulatory attorney Mark DuVal said that “A lot of MDRs (Medical Device Reports) are really boilerplate and repetitive,” and that “[i]t would be nice to be able bundle them.” According to the StarTribune, DuVal thinks that the current system of reporting MDR’s creates a lot of work for companies while doing little to inform doctors about issues that are known. Janet Trunzo, a senior executive vice president with the lobbying group AdvaMed, said in a statement that the reporting provision “will allow the agency to better focus its resources on more serious reportable events.” According to Trunzo, the quarterly summary reporting only applies to well-understood and familiar malfunction incidents. Medical device companies would still be required to file an individual report on any malfunction incident that had not been previously reported.
According to the New York Times, critics of the change do not think relaxing the rules is proper when so much already goes unreported. Jack Mitchell, director of health policy for the National Center for Health Research, said that “[p]ost-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” Mitchell thinks that loosening up the reporting rules will “exacerbate the tendency to underreport.” Ms. Tomes, who is now the chief executive of Device Events, which mines FDA’s device data to find signals of problems, also does not think this loosening of the reporting rules is in the public’s best interest. Ms. Tomes pointed out that last year, many reports about battery depletion of cardiac defibrillators were reported as “malfunctions.”
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”
According to the Notice, the exemptions from the 510(k) requirements do not apply to other statutory or regulatory requirements. Further, the Notice indicates there are limitations on some of the exemptions. Table 1 in the Notice lists exempt devices that are subject to general limitations of certain sections of the Code of Federal Regulations (CFR). Table 2 lists exempt devices subject to those general limitations and that must comply with partial exemption limitations as indicated in the table. Table 3 lists exempt devices classified as “radioallergosorbent (RAST) immunological test systems” but which are only a subset of all devices in that classification.
The FDA claims the exemptions “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.” Further, the Notice states, “regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”
The Notice was published in accordance with procedures established by the 21st Century Cures Act, which was signed into law December 13, 2016. According to the Notice, the 21st Century Cures Act requires the FDA to publish a list of each type of exempt class II device within 90 days after enactment of the Act and at least once every 5 years thereafter. The Notice reflects the FDA’s final determination regarding a proposed list of devices for exemption issued earlier this year. The relevant codified language for each listed device will be amended by the FDA in a “future action.”
It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of Medtronic’s recent interactions with the FDA.
First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action for its Newport HT70 and HT70 Plus ventilators over the potential for unexpected shutdowns, which it believes are due to software issues in the devices. MassDevice reports that is recalling well over 7,000 of the affected devices.
Next, the FDA cautioned healthcare providers against using Medtronic’s NavLock Tracker with instruments not cleared to be used with the device. The NavLock Tracker is an accessory to Medtronic’s StealthStation navigation system for use during spinal fusions. As a result, Medtronic is updating its labels on the devices to indicate that only Medtronic instruments should be used.
In early May, Medtronic received official FDA approval for a new drug-eluting stent (DES) known as Resolute Onyx. According to FierceBiotech, the stent is formed from a single strand of a cobalt alloy wire with a platinum-iridium core and can provide physicians with stent sizes up to 4.5-mm and 5.0-mm. This newly approved stent is available for use in the United States, Europe, and countries that recognize the Conformité Européene (CE) mark.
In addition, Pat Shrader, Medtronic’s Vice President of Global Regulatory Affairs, appeared on Capital Hill to request changes in device manufacturing facility inspections by government officials due to the short notice that the manufacturing facilities receive prior to inspection. Shrader was speaking on behalf of the Advanced Medical Technology Association, which includes other companies such as 3M, St. Jude Medical, and Boston Scientific. Ms. Shrader called for standardization of inspections by the FDA.
On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the FDA predicts will reach 1.7 billion smartphone or tablet users by 2018.
According to Bayer, the myBETAapp connects their BETACONNECT autoinjector (for delivering BETASERON®, a therapeutic agent for multiple sclerosis) to a patient’s mobile device or computer, and the BETACONNECT Navigator functions as a tool to view data uploaded by the myBETAapp.
According to the myBETAapp user instructions, the application will:
- Display scheduled injections according to an injection routine
- Allow the user to determine when an injection is scheduled
- Display suggested injection sites based on the injection sites shown in the prescribing information for BETASERON®
- Display a monthly calendar of recorded, missed, and scheduled injections
- Transfer and sync data recorded by the autoinjector to the corresponding injection in the calendar
- Send a notice to record injection data to the patient via email
In the press release, Bayer describes the myBETAapp and BETACONNECT Navigator as allowing further connection between the patient and the healthcare team by, with the patient’s permission, providing access to the patient’s injection history. The application is also advertised as providing further connectivity to a BETA Nurse for patients enrolled in BETAPLUS®, Bayer’s patient support program.
According to Dr. Kantor, President Emeritus, Florida Society of Neurology:
The myBETAapp and BETACONNECT Navigator work cohesively together to support communication and connection between people living with relapsing remitting multiple sclerosis and their BETA Nurse and health care team.
Bayer reports that the myBETAapp will be available for free download from the Apple app store, Google Play Store, or Betaseron.com by mid-July 2017.