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FDA's Response to the Proposed Exemption of Section 510(k) Requirements

By Richard Morroney, RAC, CQA

On January 15, 2021, the Department of Health and Human Services (HHS) issued a Notice in the Federal Register that, among other things, proposed to exempt 83 class II devices and 1 unclassified device from premarket notification. Digital pathology was among the devices covered by this proposal. 

Over the past 90 days, many pathologists -- as well as the technology industry providing digital hardware and software tools to that profession -- waited with muffled excitement on the sidelines, to see if the proposed exemptions will become permanent. Through one of our "pulse" surveys, we at Inspirata found certain confidence in public opinion weighing in favor of passing this proposal. In fact, 50% of the participants in our survey were "somewhat confident" with another 22% being "confident" or "very confident" in a positive outcome stemming from the January 15 proposal. (See our past blog post for more insights from this survey.)

After careful consideration of publicly submitted comments as well as a review of the supporting data, the FDA published a new Notice on April 16, 2021, pronouncing the withdrawal of the proposed exemptions of 83 class II devices and 1 unclassified device.

Despite the fairly confident opinions voiced by our survey takers, we are not surprised by this outcome.

FDA considers a number of factors to make determinations of this sort:

  1. The device does not have a significant history of false or misleading claims or risks associated with the inherent characteristics of the device;
  2. Characteristics of the device necessary for its safe and effective performance are well established;
  3. Changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and
  4. Any changes to the device would not be likely to result in a change in the device’s classification.

These factors are key to understanding whether a premarket notification is necessary to assure the safety and effectiveness of a device.

The January 15 Notice solely relied on a tally of adverse events (AEs) reported in FDA's MAUDE database, which houses medical device reports submitted to the FDA by mandatory reporters (i.e., manufacturers, importers, and device user facilities) as well as voluntary reporters, such as health care professionals, patients, and consumers.

The MAUDE database has certain limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biassed data. In addition, the incidence or prevalence of an event cannot be determined from AEs alone due to the underreporting of AEs, inaccuracies in AE reports, lack of verification that the device caused the reported event, and lack of information about the frequency of device use.

As a result, a low number of reports in the database could be due to a low number of marketed devices and not necessarily the risk of injury. In addition, relying exclusively on MAUDE data leaves out other important information regarding risk.

Not only is AE data inadequate on its own for assessing safety. It may provide little or no information about effectiveness for the purposes of proposing exemptions.

One additional factor that may have played a role in FDA's response relates to whether the HHS consulted with or otherwise involved, or even notified the FDA before issuing the January 15 notice. The Act provides that the Secretary (HHS) “shall be responsible for executing” the Act “through the [FDA] Commissioner.” The January 15 Notice is clearly an action “executing” the Act.

The FDA must have at least some level of involvement in this type of action given the expertise needed in evaluating whether a premarket notification submission is necessary to assure the safety and effectiveness of a device.

In summary, those were the key reasons contributing to the FDA's withdrawal of the proposed permanent waiver of premarket notification for the devices covered in the January 15 notice.

Despite the relative setback, the whole team at Inspirata strongly believes that digital pathology has passed an important milestone in its lifecycle where adoption in the near future will proceed at a much faster pace than what we have seen so far.

We are certainly not alone in our expectations. More than half of the respondents to our recent "pulse" survey agree or strongly agree with the statement that the recent developments on the regulatory front are an "attestation that digital pathology has reached maturity". 

What is coming next?

Stay tuned to our blog for more news on that topic. And feel free to check out our Dynamyx solution and its growing ecosystem of WSI scanning, image analysis, and other types of partners. This will help you understand what makes Dynamyx one of the most comprehensive workflow solutions in digital pathology. 

Tags: digital pathology, regulation, FDA, 510(k) requirements