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FDA Issues New List of 510(k) Exempt Medical Devices

FDA Issues New List of 510(k) Exempt Medical Devices

New Class II 510(k) Exempt Medical Devices As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and effectiveness of these devices can be provided by other regulatory controls. By issuing exempt status for these devices, the FDA can redirect resources that would have been spent reviewing these submissions to more significant public health issues. In March of this year, the FDA published a draft of their proposed Class II devices to be exempted in accordance with the 21st Century Cures Act. FDA is now required to publish a list of Class II devices that no longer require premarket notification, also known as 510(k) exempt medical devices, at least once every five years. 93 product codes are now 510(k) exempt subject to partial exemption limitation in addition to general limitations. So, it will be important for manufacturers to confirm if their device is indeed exempt. For example, FDA exempted devices regulated under product code DHB (Radioallergosorbent immunological test system), but they do not believe all products with the product code DHB meet the partial exemption limitation. Therefore, you are still required to file a 510(k) submission if your device falls under product code DHB and is not identified on the list. Pending 510(k) Submissions Medical device manufacturers with pending 510(k) submissions that are now on the list of exempted devices are directed to withdraw their submission. This is great news for these...
FDA to Create a Digital Health Unit

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital health premarket review timelines. Digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. The creation of this unit is part of the Medical Device User Fee Act (MDUFA). MDUFA is the program that authorizes FDA to collect user fees from medical device manufacturers in support of streamlining the regulatory approval process. Negotiations between FDA and the medical device industry regarding the fourth version of MDUFA are currently underway. As part of the negotiation process, FDA proposed to hire technical experts to staff the new digital health unit. In addition to MDUFA, the 21st Century Cures Act requires FDA to develop a framework for evaluating real world evidence. FDA envisions that the digital health unit will monitor and implement the use of real world evidence to support the regulatory approval process. FDA issued a draft guidance in July 2016, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, that identifies how real world data will be evaluated to determine if it is sufficiently relevant and reliable enough to be used. While the FDA sees the digital health unit as a means of streamlining the regulatory approval process, it also recognizes it will require coordination with industry and other government agencies because digital health touches on...
Cybersecurity’s Impact on Health Systems

Cybersecurity’s Impact on Health Systems

We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient. In recent years, researchers have demonstrated the potential threat of medical device and healthcare system hacking. They have been able to tamper with pacemakers, insulin pumps and other devices, which, if hacked, could cause serious harm, including death, to a patient. Recently, the FDA identified cybersecurity vulnerabilities in St. Jude Medical’s implantable cardiac devices and the corresponding Merlin@home Transmitter. These vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient’s physician, to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. While no patients were harmed, this serves as a warning that similar devices containing configurable embedded computer systems can be vulnerable to cybersecurity intrusions and exploits, as well. To address these technological risks, in December 2016, the FDA finalized the guidance, “Postmarket Management of Cybersecurity in Medical Devices.” In reference to the guidance, Suzanne B. Schwartz, M.D., M.B.A., FDA’s Associate Director for Science and Strategic Partnerships, at the Center for Devices and Radiological Health stated that, “manufacturers should build in cybersecurity controls when they design and develop the device to assure proper device performance in the face of cyber threats, and then they should continuously monitor and address cybersecurity concerns once the device is on the market and being used by patients.” The new guidance...
Obama Signs the 21st Century Cures Act into Law

Obama Signs the 21st Century Cures Act into Law

Last night, President Obama signed the 21st Century Cures Act into law. Most of what people will be hearing from the media will be focused on the Act’s support of cancer research, mental health policies, brain research to tackle diseases like Alzheimer’s and the funding allocated for these initiatives. However, the 996-page bill also includes major changes that impact the way the FDA regulates drugs, devices and biologics. Those who have spoken out against the Cures Act have done so out of fear of a weakened system that would allow for less rigorous examination of products before they go to market. While there are sections of the act that appear to streamline submission and review processes, until the FDA develops the necessary guidances based on their interpretation of the requirements, the industry will not know what to expect. The best way to approach these pending changes is to become familiar with the areas that might impact your device. The following summarizes provisions relevant to medical device companies: Sec. 3001 Patient Experience Data Under the Cures Act, FDA would be required to include a statement regarding any patient experience data that was used at the time of a drug’s approval. The bill defines patient experience data as “data collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers).” While this section specifically refers to drugs, this may come into play for combination products, as well. This requirement, as well as section 3002, is one to watch to determine if it affects your product commercialization goals. Sec. 3033 Accelerated...
What Happens When the FDA says, “I don’t know”

What Happens When the FDA says, “I don’t know”

The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to fully characterize the causes, incidence, and short- and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment.” This basically equates to the FDA saying, “I don’t know.” The FDA has recently released a guidance, which will formalize its practice on notifying the public of situations when the agency is monitoring risks that have not yet been fully validated, and therefore, do not have FDA recommendations. Historically, the FDA has communicated important medical device post-market information after having analyzed available data and, in most cases, after having reached decision about relevant recommendations and about whether or not further regulatory action is warranted. According to the guidance, timely communication about emerging signals is intended to provide health care providers, patients, and consumers access to the most current information concerning the benefits and risks of marketed medical devices so they can make informed treatment choices based on all available information. Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated. Considerations for Determining FDA Public Notification will include: Seriousness of the adverse event(s) relative to the known benefits of the device Magnitude of the risk (e.g., likelihood of occurrence) Magnitude of the benefit Strength of the evidence of a causal relationship...