Industry Questions FDA’s Draft Guidance on Abbreviated 510(k)s

Stakeholders asked the FDA to clarify its proposal to expand the Abbreviated 510(k) program by allowing the use of performance criteria for demonstrating substantial equivalence.

Most comments on the agency’s draft guidance asked for clarity on how the program would be different from the existing 510(k) process.

One industry group, the Bringing Real-World Insight for Device Governance and Evaluation (BRIDGE) Coalition, said more public input is needed to decide which products should be eligible for the program.

The FDA should expand on the definitions and processes within the guidance, such as when additional data is required and how criteria will be established, it said in its comments on the draft guidance, the coalition said.

It urged the agency to explain how the expanded abbreviated 510(k) pathway differs from the existing system and whether there are expectations for the number of submissions the FDA expects to see.

The coalition also expressed concern over the flexibility of performance criteria and asked for clarity on how the criteria would be kept current.

It said it was “looking for information on why this new approach will be of use to FDA and stakeholders,” and it questioned whether there could be a performance standard in situations where there is no predicate device.

The Medical Imaging & Technology Alliance raised similar questions in its comments, saying it was concerned about the clinical and scientific evidence standards for validating equivalent analytical and clinical performance “despite the lack of direct comparisons with the predicate device.”

It said the benefit of using the program is unclear in that the Special 510(k) program is 30 days while both the abbreviated 510(k) and the traditional 510(k) program are 90 days. “A clearly stated reduction in review time would be helpful,” MITA said.

In addition, the association stressed that many devicemakers sell their products in global markets, and the FDA should approach proposed performance criteria and standards with “global harmonization in mind,” to reduce the burden on industry to comply with multiple regulatory requirements across different jurisdictions.

The Alliance for Quality Medical Device Servicing, which is comprised of independent service organizations that provide third party services to device manufacturers, said specific language should be added to include service and maintenance procedures, methodologies, tools and documentation that would be made available to all servicers, including end users and third-party service organizations.

The alliance said it “believes that by doing so the FDA will help address restrictive and anti-competitive practices that are deliberately limiting or preventing access to these materials.”

It stressed that providing such access would help ensure safety through the total product lifecycle of medical devices, adding that collaboration between independent service organizations and original equipment manufacturers is “paramount to providing safe, high quality and cost-effective service.”

To that end, the FDA should state in the guidance that OEMs submit service and maintenance materials as part of the device description in the 510(k) and make them available. This would not increase the burden on OEMs but “reinforces the need to make available these outputs which are already required as part of existing regulations.”

Read the full comments here: www.fdanews.com/07-19-18-Comments.pdf.