Blog Tag: FDA
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.” The FDA provides this draft guidance following a December 2017 Government Accountability Office (GAO) report assessing the FDA’s application of the “least burdensome” approach to regulation.
The least burdensome mandate for medical devices has been a part of the FDA’s governing law since Congress’ passage of the FDA Modernization Act of 1997. Its intent is to eliminate unnecessary delays for approving new devices, while still maintaining the statutory requirements for approval. The GAO report found that, between 2013 and 2016, device sponsors had appealed FDA staff decisions to agency management a total of 63 times. Of these 63 appeals, 33 raised issues related to the FDA’s application of the least burdensome approach, and the FDA at least partially agreed in 11 of these cases. The GAO report further notes that the FDA has not evaluated its compliance with the least burdensome mandate and suggests the development of performance metrics to meet this end.
FDA Commissioner Scott Gottlieb states that he is “fully committed” to implementing the least burdensome mandate. The draft guidance defines least burdensome to be the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.” The guiding principles espoused in the draft guidance include the FDA’s intent to require the “minimum information necessary to adequately address the regulatory question or issue at hand,” a call for industry sponsors to submit “well-organized, clear, and concise information” for the FDA to review, and the FDA’s commitment to apply regulatory approaches that “fit the technology, taking into account its unique innovation cycles, evidence generation needs, and timely patient access.”
The draft guidance also provides examples of how the least burdensome approach can be applied. For example, it suggests that:
- Computer modeling and simulations “should be used to support medical device safety and effectiveness as alternatives to traditional benchtop or animal performance testing in appropriate circumstances.”
- “Alternative approaches should be considered, when appropriate, to optimize the time and resources of FDA and industry. Both FDA and industry should understand that there are often
multiple ways to satisfactorily address a particular regulatory issue. The resolution of the regulatory issue should be based on a discussion about which method is least burdensome, while still satisfactorily addressing the regulatory issue.”
- “Bench performance testing should be considered to address preclinical or clinical endpoints,
when appropriate. This may include bench models for anatomy, such as evaluating tortuous
paths for catheters used across many clinical applications.”
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 FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves. The American Clinical Laboratory Association describes LDTs as:
[T]ests that hospitals, academic, and clinical laboratories develop as testing services according to their own procedures. These tests are often created in response to unmet clinical needs, and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment.
The organization believes that the ability to innovate and design custom diagnostic tests has been critical to the growth of personalized medicine and keeping pace with the changes in the medical profession.
According to Sean Khozin, associate acting director of the FDA’s Oncology Center of Excellence, the program will be modeled after the FDA’s pilot approval process for digital health products. This process functions as a stamp of approval by the FDA, Mr. Khozin explained that:
The precertification program represents a modern approach to regulation, shifting the focus from the product, to the developer of the product . . . . That product then doesn’t necessarily have to go through analytical validation process.
This program may be compared to to the Digital Health Software Precertification (“Pre-cert”) Program that was announced in July, 2017. The agency picked nine companies for the program, including Alphabet Inc. (Google’s parent company), Apple Inc., and Fitbit Inc. Under the Digital Health SOftware Pre-cert program, the FDA will examine the software (rather than the device itself) and inspect facilities to ensure they meets the FDA’s standards. If the companies pass the audit, the companies will attain pre-certified status and their products will be pre-cleared in lieu of being examined by the FDA’s traditional regulatory framework.
Regulating LDTs has been an issue that the FDA has considered in response to a “boom” in the diagnostics industry and as more physicians demand complex tests to screen for diseases like breast cancer and Alzheimer’s.
The medical device and clinical laboratory industries have been at odds over the question of LDT regulation since 2014, when the FDA first sought to regulate LDTs. Device makers supported the FDA’s regulation-based approach while clinical labs, which were already regulated by the Clinical Laboratory Improvement Amendments (CLIA) under the Centers for Medicare & Medicaid Services, disagreed. The FDA dropped its enforcement proposals in 2016. The American Clinical Laboratory Association, whose members traditionally have been regulated under CLIA, said:
[The ACLA] has consistently maintained that LDTs are not medical devices and cannot be regulated as such. The decision by the FDA last year to not issue final guidance to regulate LDTs was a victory for diagnostic innovation and for patients.
The FDA is now expected to announce a new pilot plan soon to certify laboratories that develop diagnostic tests in lieu of drafting rules for the tests themselves. The plan for the LDTs do not seem to conflict with CLIA rules as the CLIA rules does not concern manufacturers, the CLIA rules concern labs.
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.
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the “IlluminOss System”). According to the FDA, the de novo clearance is reserved for new, novel devices whose type has not been previously classified.
IlluminOss, a privately held commercial-stage medical device company based in East Providence, Rhode Island, describes itself as being involved in the development and commercialization of minimally invasive fracture fixation techniques. The company explains that the newly-approved IlluminOss Bone Stabilization System is used for the treatment of impending and actual pathological fractures of the humerus, radius, and ulna resulting from metastatic bone disease.
Traditional bone stabilization procedures utilizing invasive techniques and intramedullary rods can risk causing extensive soft tissue damage and reduced patient mobility. Moreover, the metal plates and rods may increase patients’ risk of cortical porosis, delayed bridging, and refractures upon removal. Regarding its IlluminOss System, IlluminOss states:
The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.
In contrast to traditional fixation techniques, the IlluminOss explains that its System uses a small-diameter PET balloon and visible light fiber, each of which may be threaded through a 4.5 mm pathway into the medullary canal through a small incision in the patient’s skin. Once inserted, the PET balloon is filled with a photoactive liquid monomer, causing the balloon to expand and conform to the specific shape of the patient’s bone. With the liquid-filled balloon in place, the photoactive monomer is polymerized utilizing the visible light fiber, resulting in a hardened implant which conforms to the patient’s specific bone structure within 90 seconds. The hardened implant stabilizes the fracture by providing both longitudinal and rotational stability across the length of the implant.
The IlluminOss System has been available internationally since 2010. IlluminOss reports success in international markets: surgeons have reported smaller incisions, shorter procedure times, and a faster return to the patient’s daily living activities. Reduced complication rates, and shorter hospital stays have also been observed.
With marketing clearance in hand, IlluminOss plans to initiate U.S. commercialization efforts in the second quarter of 2018.
The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via taking fingertip blood samples using a fingerstick.
Traditionally, fingersticks required one to prick their finger to obtain blood droplets for diabetes monitoring devices to work. The Libre flash instead uses a more discreet method of operation–a small sensor wire is inserted below the skin’s surface which continuously measures and monitors glucose levels. According to Abbott, a mobile reader is used to measure glucose levels when a user waves the mobile reader above the sensor wire. It is intended for use in people 18 years of age and older with type I or II diabetes. After an initial 12-hour acclimation period, it can be worn for up to 14 days. Because a diabetic patient’s pancreas can not produce insulin, those patients frequently must monitor their blood sugar and regularly inject themselves with insulin when their blood sugars spike.
Bloomberg and Reuters report that other companies have been left behind. Johnson & Johnson is closing its insulin-pump unit after failing to keep up with Medtronic Plc. DexCom Inc., the current leader in glucose-monitoring systems, which, in turn, lost a third of its market value on Sept. 28 after Abbott’s Libre got approval.
The Centers for Disease Control and Prevention notes that more than 30 million people in the U.S. have diabetes. People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). When the body doesn’t have enough insulin or cannot use it effectively, sugar builds up in the blood. High blood sugar levels can lead to heart disease; stroke; blindness; kidney failure; and amputation of toes, feet or legs.
According to Bloomberg, “the bulk of the sales are to the 1.25 million American diabetes patients with the most severe form of the disease, type 1. There’s a larger, mostly untapped market: the about 20 million Americans with type 2, whose body’s ability to use insulin fades slowly over time and who don’t regularly use tools to manage their disease.”
The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG within 30 seconds and display the results on the Apple Watch or iPhone. In conjunction with the KardiaBand, AliveCor is introducing “SmartRhythm, a new feature within the Kardia app for the Apple Watch.”
Portable EKG readers for smart phones are not new; several are on the market already. However, none of them can tell the patient when to take an EKG. The KardiaBand solves that problem. The combination of the KardiaBand and SmartRhythm will use the Apple Watch’s sensors “to continuously evaluate the correlation between heart activity and physical activity,” and alert the user to take an EKG using the KardiaBand when the “heart rate and activity are out of sync.” According to Dr. Eric Topol, director of the Scripps Translational Science Institute,
[The KardiaBand] is continuously monitoring your heart rate to let you know if something is potentially off track. That’s the big difference.
AliveCor eplains that the Kardia app will display the results of the EKG on the Apple Watch and alert the patient if atrial fibrillation (Afib) is detected. If necessary, the results of the EKG can be emailed directly to a physician. Dr. Topol believes that this technology will “markedly increase the number of EKGs taken,” which will potentially save lives, because Afib often goes undetected.
The news of KardiaBand’s approval comes within days of Apple’s announcement of the Apple Heart Study in conjunction with Stanford Medicine, which will investigate the detection of Afib using the sensors already embedded in the Apple Watch. However, in a recent interview, AliveCor’s CEO, Vic Gundotra, distinguished the KardiaBand from the heart rate and activity sensors already found on the Apple Watch:
Apple might be able to say ‘oh your heart rate is high’ …but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do?. Any doctor will say ‘ok come in, let’s get an EKG reading.’ . . . It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.
AliveCor touts the FDA’s approval of KardiaBand as a reason patient’s can be confident in the results of AliveCor’s mobile real-time EKG technology. In another interview, Mr. Gundotra stated
The average consumer doesn’t know what a normal sinus rhythm looks like or what atrial fibrillation looks like. Yet the FDA has cleared our individual algorithms. The consumer can have confidence that this is FDA-cleared. And frankly, we have the clinical studies to prove it.
The results of a recent study showed a 4-fold increase in Afib detection when using AliveCor’s mobile 30-second EKG technology. That same study showed that when using mobile EKG technology, such as the KardiaBand or AliveCor’s other device, fewer cases of Afib went undiagnosed.
The KardiaBand is available on AliveCor’s website for $199.
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices currently on the market that are manufactured using 3D printers. Importantly, many of these devices can be tailored to fit a specific patient’s anatomy. For example, the FDA has reviewed 3D-printed knee replacements and implants for facial reconstruction.
The new guidance gives the FDA’s recommendations regarding the content of FDA submissions, device testing, and manufacturing considerations for 3D printed devices.
[This guidance] will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.
The new guidance comes on the heels of recent FDA approvals for several 3D-printed devices, including Medicrea’s 3D-printed titanium interbody device for spinal surgery. The FDA also recently approved a 3D-printed drug tablet, the epilepsy drug Spritam, marketed by Aprecia Pharmaceuticals.
Commissioner Gottlieb further opined that “3D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them.” He noted that 3D printing could one day be used to treat burn patients by printing their own skin cells onto their wounds or used to grow replacement organs.
Commissioner Gottlieb noted, however, that the FDA’s new guidance is intended only “to provide the FDA’s initial thoughts on an emerging technology” and that the FDA’s recommendations likely will change as 3D-printing technology develops.
A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s Unique Device Identification (UDI) system.
According to the post, Dutch hospitals agreed to use UDI codes exclusively for identification and traceability of medical devices, and industry promised to place only UDI codes on device labels. According to the Emergo post, this means that every manufacturer that wants their devices used in Dutch hospitals now needs to provide UDI codes on those devices.
An article from Securing Industry cites to the the Dutch Ministry of Health as saying that the decision to use the FDA’s UDI system was made to avoid adding complexity for manufacturers by requiring a separate system. According to the article, the Netherlands is the first in the EU to adopt the FDA’s UDI system, a decision that some believe may increase the chances of the UDI system being adopted elsewhere in the region.
In 2013, the US published the rule requiring UDI codes to be assigned by device manufacturers to each version or model of a device. Under the published rule, the codes must be in both human and machine readable formats. According to the FDA, implementation of UDI codes improves patient safety, modernizes device postmarket surveillance, and facilitates medical device innovation.
On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or rapid depletion of the devices’ batteries, according to the FDA’s statement. Instead of removing and replacing the pacemakers, the recall is designed so that doctors will install a firmware upgrade that removes the vulnerability.
Newsfactor reports that there have been no reported exploits of the vulnerability and no devices have yet been compromised.
The recall highlights that medical device manufacturers are beginning to take a more focused approach to cybersecurity. Mac McMillan, CEO of privacy and cybersecurity firm Cynergistek, told Modern Healthcare that “If devicemakers didn’t already have developers sitting around looking at cybersecurity, they now have to incur the costs of making sure their devices stay current. In the past, they’ve developed devices and put them on the market and moved onto the next device. This is a new thing for them.”
Mike Kijewski, CEO of medical device security company Medcrypt, also suggested that the FDA should update its regulations to help medical device companies stay on top of cybersecurity threats. “If the FDA can say you’re just doing the update for cybersecurity and the changes are minimal and the functionality of the device isn’t changing, they can make the update happen faster,” Kijewski suggested.
Canada’s equivalent of the FDA, Health Canada, is still looking into the vulnerability and its proposed solution, and has set a target of 75 days to resolve the situation.
According to the press release, the Speedboat RS2 device and the associated CROMA energy platform received premarket clearance through the 510(k) process by demonstrating that the device is substantially equivalent to an existing legally marketed device. According to Creo, the FDA clearance was received earlier than expected. Expected to take roughly six months, the 510(k) process was completed just 49 days after submission.
The Speedboat RS2 device for endoscopic submucosal dissection is said to be the first of several devices planned for use with Creo’s CROMA radiofrequency and microwave generator. According to the announcement, the Speedboat RS2 is intended for removal of early stage cancerous and pre-cancerous lesions, and combines bipolar radiofrequency cutting and microwave coagulation for precise dissection and controlled hemostasis. The combined functionality is said to reduce the risk of puncturing tissue and enhances the safety profile of endoscopic lesion removal. According to Creo’s CEO Craig Gulliford,
Over the coming weeks, we will be looking to bring forward the development of our US capabilities whilst continuing with the promising training programme underway in Europe.
The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care. The FDA defines “pediatric” as encompassing devices used for patients who are 21 years of age or younger at the time of diagnosis or treatment.
Many of the consortia hold innovation competitions where winners are awarded grants and support services. For example, PR Newswire reports that the New England Pediatric Device Consortium (NEPDC) has awarded three companies grants and in-kind services for products aimed at preventing the dislodgement or unintended removal of catheters or tubing. According to NEPDC’s Request for Abstracts, the grants are up to $50,000 each. NEPDC offers quarterly grant opportunities; the next abstract deadline for grant funding is October 9, 2017, with applications due on October 23, according to PR Newswire.
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) has narrowed a record number of 98 applications from across the globe down to twelve finalists, according to PR Newswire. This is the 5th annual Pediatric Device Innovation Symposium hosted by NCC-PDI, a FDA-funded consortium led by the Sheikh Zayed Institute for Pediatric Surgical Innovation and A. James Clark School of Engineering at the University of Maryland according to the competition’s homepage. NCC-PDI highlights that up to six finalists will be awarded up to $50,000 each after the presentations held on September 24, 2017.
Another consortia, the Atlantic Pediatric Device Consortium (APDC), announced that it will hold Round 1 winner presentations at its 7th annual Pediatric Device Innovation Competition on September 25, 2017. The proposal deadline was July 31, 2017, and award winners will be notified on October 30, 2017, according to APDC.
Also, in January of 2017, the Philadelphia Pediatric Medical Device Consortium (PPDC) announced that it chose three companies from eight finalists to receive seed grants of $50,000 each. The PPDC announced that the Request for Applications for its next Sponsored Project Proposals begins on September 11, 2017.
According to a 2016 FDA review, the FDA-funded pediatric consortia have advised 406 pediatric device projects and innovators since 2013, and as of the first fiscal quarter of 2016 there were 10 patents obtained and 5 devices available for use in the care for pediatric patients.
Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
Globus Medical, which describes itself as a musculoskeletal implant manufacturer, acquired the robotics developer Excelsius Surgical and its robotic guidance device Excelsius GPSTM three years ago according to press releases. The Excelsius GPSTM platform is said to function as a robot-assisted surgery guidance system “designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement,” according to the press release. Globus Medical further describes the platform as being compatible for use with pre-operative CT, intra-operative CT, and fluoroscopic imaging modalities.
The FDA’s decision is stated to allow the platform for use within minimally invasive and open orthopedic and neurosurgical procedures, including screw placement applications in spine and orthopedic surgery. This announcement also follows Globus Medical’s earlier news release announcing that the Excelsius GBSTM system received CE mark approval in the European Union.
Norbert Johnson, Vice President of Robotics, Imaging, & Navigation at Globus Medical, views these results as an example of Globus Medical’s developmental capabilities:
We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.
The Excelsius GPSTM received FDA 510(k) clearance after Globus Medical re-filed its 510(k) bid following an FDA decision that Globus Medical’s initial bid had not “sufficiently addressed the FDA’s questions,” according to Mass Device.
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 bill still needs to be passed in the Senate before being signed into law by President Trump.
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.”
Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees
The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the Prescription Drug User Fee Act, the Medical Device User Fee Amendments, the Generic Drug User Fee Amendments, and the Biosimilar User Fee Act.
The Trump Administration’s Statement includes the following recommendation:
“The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs. In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”
This call for the FDA to be fully funded by user fees paid by medical-device and pharmaceutical companies echoes previous statements from the Trump White House. In May, the Trump Administration released its budget proposal for Fiscal Year 2018, which called for the elimination of federal funding of premarketing review programs at FDA. Trump’s budget proposed that FDA user fees should be recalibrated from approximately $1.2 billion in 2017 to over $2.4 billion in 2018. The FDA currently receives about 60% of its funding for premarketing review from user fees.
Scott Gottlieb, the newly confirmed FDA commissioner, has expressed his support for increasing user fees as a way for funding FDA activities. FDA’s budget request for 2018 seeks $3.2 billion in user fees—a reported increase of 68 percent from 2017 levels.
Some industry experts have expressed concern that a large increase in FDA user fees could discourage innovation and keep smaller companies such as digital startups from entering the market. Increasing FDA user fees would also complicate existing user fee agreements that FDA negotiated with the medical device industry last summer.
While the future of user fees remains uncertain, the Trump Administration and FDA’s persistence in calling for higher user fees suggests that fee hikes could be looming—a development that could have major effects on the medical device industry.
The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define “what clinical validation looks like for software,” and will consider creating new premarket approval or clearance procedures for digital health products.
As Patel stated in an interview with Wired, the new unit will aim to keep up with emerging technology that uses artificial intelligence and machine learning to diagnose and treat patients. Patel noted that this kind of technology creates new and difficult challenges for regulators, who must figure out how to ensure that patients remain safe while keeping up with the increasing complexity and tighter release schedules that these new kinds of software bring.
“We’ve been trying to translate the current regulation paradigm for digital . . . [b]ut what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.” –Bakul Patel, Associate Center Director for Digital Health, FDA
Wired reports that Patel is working to develop new models for testing and approving digital health products. Patel told Wired that “the idea is to get safe products to market faster, by having people compete on excellence rather than compliance.” One way the FDA might do this is by providing faster review with lower scrutiny for manufacturers with a long track record of safety and compliance.
According to FierceHealthcare that the new digital health unit will be part of the FDA’s Center for Devices and Radiological Health. While the new unit won’t be officially open until October, hiring of key staff is underway. Wired notes that the unit will be funded by the Medical Device User Fee program.
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.
The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus is disconnected from the lower esophagus and the stomach. According to the FDA, babies with this condition require a feeding tube until surgery can be performed to connect the esophagus to the stomach.
According to Cook Medical, its pediatric esophageal atresia anastomosis device, called Flourish™, uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and one of the joint inventors listed on the patent on this technology (U.S. Patent No. 9,168,041), states:
“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases. Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”
Cook Medical’s press release notes that each of the 16 infant patients treated using this device had a successful joining of their esophagus with no remaining gap, within 3‑10 days after receiving the device.
According to the Cook Group, Cook Medical is a company that engages in “medical research and product development in minimally invasive medical device technology for diagnostic and therapeutic procedures.”