FDA adds Class II Device 510 (k) Waiver Review Channel modernization steps.

Under the 21st Century Cures Act, the FDA should publish a list of Category I and Class II devices exempt from the 510 (k) exemption at least every five years.
2017, the FDA waived 510 (k) requirements for more than 70 Class I devices and 1,003 Class II devices under the Act.
July 22 this year, the FDA confirmed the addition of five Category II medical devices 510 (k) requirements, and detailed the exemption of four of them.
exemptions would ease the regulatory burden on device manufacturers.
FDA also said it has assigned new codes to the types of devices that are partially exempt to the waiver, ensuring that they can be separated from devices that are not partially exempt under the current code system.
the FDA regulates approximately 6,500 medical devices under the Risk Classification System.
this risk classification system, according to the reasonable security necessary for the level of regulatory control and effectiveness, the risk is divided into low, moderate, high three levels.
devices classified as moderate risk, such as spinal fixers, soft digestive endoscopy, etc., account for nearly half of all device types.
FDA review of such devices, known as the 510 (k) channel.
the pace of reform of the 510(k) channel, which has attracted much attention because of the significant safety risks that preceded the listing of devices that were licensed for the market through the review channel, such as pelvic patches and metal-metal hip implants.
source of data: References, Pharmaceutical Mingconcontent Content Team Mapping On the other hand, because low-risk devices are basically not subject to pre-market review, and relatively few devices are classified as high risk, the number of medical devices entering the market through the 510 (k) channel exceeds 90 percent of the medical devices reviewed by the FDA.
Photo Source: References In 2011, the American Academy of Medicine (IOM) recommended to the FDA that the channel should be replaced after concluding that it does not adequately ensure the safety, effectiveness, and technological innovation of the device.
FDA responded at the time by choosing to improve existing channels because of a lack of viable alternative shipping lanes.
September 2019, the FDA issued four guidelines, taking steps to reform the 510 (k) channel.
source of images: References, scholars from the Massachusetts Eye and Ear Hospital, Harvard Business School, Yale University School of Medicine, yale-New Haven Hospital, wrote in the New England Journal of Medicine in October last year that there are several issues that need to be addressed if expectations of impending changes can actually change the regulation of devices that serve patients and clinicians.
510 (k) Review Channel Development Review The 1976 Medical Device Amendment Bill marks the beginning of modern medical device regulation.
, Congress established a 510 (k) channel, established a risk classification system for medical devices, and authorized the FDA to develop appropriate review standards.
under this law, the FDA generally does not require pre-market clinical evidence to support licensing of medical devices with a moderate risk level;
, however, the 510 (k) channel requires the device manufacturer to certify that the device is "indeed equivalent" ("vally ally" in terms of intended use and technical characteristics (with the exception of permitted exceptions) to the device currently on the market (the "reference" device/predicate that has been listed).
1998, the FDA introduced a special 510(k) program and a simplified 510(k) program that allows device manufacturers to obtain permission by proving that the device meets pre-specified performance standards (for example, a bile duct stent test must be performed using a standard method to prove adequate corrosion resistance).
Photo Source: References: The FDA has made the 510 (k) device application review channel successful by taking specific measures.
Despite the increasing number and complexity of applications, the FDA has achieved a low recall rate (about 1 to 2 percent per year) and a short review time frame (approximately 60 days).
FDA's commitment to review at least 95 percent of 510 (k) applications within 90 days to promote market access and ultimately achieve the goal of promoting innovation.
in addition, in recent years, the FDA has eliminated some of the troublesome practices permitted by the 510 (k) channel, such as the removal of exemptions that would have helped grant permits to some high-risk devices;
, for example, an automatic in vitro defibrillator fails, leading to death.
photo source: References, devices rarely require clinical evidence until they are licensed, but this approach is often prudent.
manufacturers frequently submit 510 (k) applications for device label descriptions (e.g., changes to use instructions), design changes (e.g., routine software updates), or manufacturing changes that do not require clinical testing assurances,' but the regulator is not expected to require clinical testing of these changes.
note, the FDA does not require pre-market clinical testing for approval of similar modifications to high-risk devices.
can demonstrate that the evaluation of the potential impact of these changes, especially for rare adverse events, is sufficient or superior to clinical studies through non-clinical studies such as laboratory, animal, and modeling studies.
, mandatory pre-market clinical studies do not prevent devices associated with long-term adverse events from being licensed, nor from recalled devices due to post-market issues, such as manufacturing errors.
these devices account for the majority of device Class I recalls.
Category I recall is the most relevant to the health hazard.
in fact, it is estimated that less than 10% of the category I recalls of devices relate to clinical risks that may be identified in pre-market testing.
source of data: References, Potions and Kant Content Team Mapping However, there are several reasons why 510(k) channels may cause under-tested devices to be licensed: relying on loose standards that are "true equivalent" to help obtain licenses for inadequate devices;
, the FDA is expanding the simplified 510(k) channel based on performance standards and the extended simplified 510(k) channel, renamed the Safety and Performance Channel.
this method can alleviate the important limitations of pre-market device testing.
traditional 510 (k) channels, which objectively result in device manufacturers tending to choose the most advantageous reference devices, performance standards, and performance thresholds to meet the minimum requirements for obtaining a license, while other reference devices, performance standards, and thresholds are ignored, but safety and performance-based channels (the Safety and Performance Based Pathway) can use pre-specified standards and thresholds to raise the bar for evidence that is permissible.
pre-specified performance standards to help ensure consistency assessment sourcing devices based on the technologies or clinical specifications that are most critical to safety and efficacy.
pre-specified performance thresholds to help prevent over-use or unsafe reference devices.
to publish the performance of devices related to these standards can promote innovation by promoting data-driven competition among device vendors or by speeding up review times.
the authors of three recommendations on the 510 (k) channel reform In order to maximize the potential of the reform channel, the authors of the above-mentioned article argue that the FDA should implement three other measures.
first of all, this channel may be mandatory for all eligible devices.
device manufacturers rarely use simplified 510 (k) channels, indicating the possibility of avoiding more stringent, voluntary pre-market reviews.
, for the types of devices that are frequently recalled, such as catheters for transdermal coronary arterial aphorismsandala and antibacterial susceptibility testing, priority can be given to extended channel supervision.
15 types of devices accounted for about 60 per cent of the category I recalls of moderate risk devices between 2001 and 2018, according to the International Consortium of Investigative Journalists.
, regulators can use the best standards obtained from literature reviews and FDA internal data to establish methodologies.
these pre-established performance standards may reflect the average relative to the average of the existing reference devices rather than the improved performance, thus maintaining a relaxed standard for device manufacturers.
other strategies the FDA is considering to improve the safety of moderately risky devices, such as publishing a list of reference devices or device vendors that rely on longer than a specified year, such as 10 years.
However, some older reference devices may be required as high-performance reference standards for new devices;
, the fact that reference devices with older references may be less likely to be recalled, may be contrary to intuition, compared with reference devices with newer references.
better solution would be for Congress to authorize the FDA to take full advantage of regulatory expertise and ban outdated devices as reference devices.
as the FDA considers additional measures to strengthen the 510(k) channel, it should be enhanced for post-market assessments to match more stringent pre-market testing.
The FDA's pre-market research of 510(k) devices is currently for limited clinical and regulatory purposes due to the scope, duration, and delays of post-market research.
using real world data (RWD) national health technology assessment system (RWD) may help clarify the broader safety and efficacy of medium-risk devices.
FDA could also seek authorization to conduct post-market studies to verify the relationship between pre-market technology and patient outcomes.
data generated by these studies, it can better inform patients, clinicians, payers, device manufacturers, and FDA decisions.
the FDA has taken an important step in addressing long-standing weaknesses in the 510 (k) channel.
however, voluntary security and performance channels will be similar to the previously used simplified 510 (k) channels.
regulatory agencies must take additional mandatory measures to meet their commitment to this reform.
all stakeholders, especially device manufacturers and legislatures, should support the FDA in better protecting patient and public health.
References: (HHS). Fda. Medical Devices; Exemptions from Premarket Notification: Class I Devices. Apr 7, 2017. Retrieved Jul 25, 2020 from .2 HHS, FDA. Medical Devices; From The Sves from Premarket Notification: Class II Devices. Jul 5, 2017. Retrieved Jul 25, 2020 from [3] HHS, FDA. Medical Devices; From The Sves from Premarket Notification: Class II Devices. Jul 22, 2020. Retrieved Jul 25, 2020 from .4 Medical Devices and the Public's Health: The FDA 510 (k) Clearance Process at 35 Years. July, 2011. Retrieved Nov 3, 2019 from ./media/files/report%20Files/2011/medical-Devices-and-the-Public-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Times 202011.20Report 20. The FDA Medical Device User Fee Program: MDUFA IV Reauthorization. June 6, 2016. Retrieved Nov 4, 2019 from the FDA CDRH, CBER. The Special 510(k) Program: Guide for Industry and Food and Drug Administration Staff. Sept 13, 2019. Retrieved Nov 4, 20.