510(k) Submissions: CDRH Releases Four Final Guidances

Regulatory NewsRegulatory News | 12 September 2019 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviated 510(k)s and CDRH’s refuse to accept policy for 510(k)s.

As part of a wider, ongoing push to modernize FDA’s 510(k) program, the final guidance documents provide more clarity on several programs the agency has been working on for the last couple of years.

Special 510(k)

For the Special 510(k) program, which offers an optional pathway for manufacturers to make modifications to marketed devices, CDRH says in the final guidance that the program was previously “limited to review of changes that did not affect the device’s intended use nor alter the device’s fundamental scientific technology,” but now its focus is on “whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.”

The final version also adds that a Special 510(k) “would generally not be appropriate for devices that manufacture a biological product at the point of care, because there would likely be no well-established method to evaluate such changes and/or the performance data would not be reviewable in a summary or risk-analysis format.”

Appendix B in the final guidance, which includes examples of changes that can be submitted as a Special 510(k), includes five additional examples (B.11-B.15) that were not included in the draft version of the guidance.

But the final guidance only revises the wording around how a submitted special 510(k) would be converted into a traditional 510(k) and does not address questions raised by manufacturers with the draft.

The release of the final guidance also follows CDRH’s launch of a pilot program in October 2018 related to the expansion of the Special 510(k) program.

Abbreviated 510(k)

Following efforts to further expand the Abbreviated 510(k) program in April 2018, CDRH published a 7-page guidance on Thursday that supersedes the Abbreviated 510(k) content from the March 1998 guidance, “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”

The Abbreviated 510(k) program is centered on the use of an efficient submission preparation and review process that relies on guidance documents, special controls and/or voluntary consensus standards.

FDA says in the guidance that it “believes that, within the Abbreviated 510(k) Program, the use of guidance documents may facilitate the review of 510(k)s through a reliance on a ‘summary reports’ that briefly describe and summarize the testing performed to support the submission as recommended in relevant guidance document(s). These reports summarize the device description, the manufacturer’s device design requirements, risk management information, and a description of test methods used to address performance characteristics.”

Comments on the draft version to expand the Abbreviated 510(k) questioned the benefit of such a program and wondered if manufacturers would use it.

Format for Traditional and Abbreviated 510(k)s

Superseding a previous guidance released in 2005, this 21-page final guidance explains how to format an original submission for a traditional or abbreviated 510(k) submission.

The guidance outlines and describes the 20 sections for traditional and special 510(k)s, which includes information on animal and clinical performance testing, proposed labeling, biocompatibility and software, among others.

Refuse to Accept Policy for 510(k)s

This 103-page final guidance explains the procedures and criteria that CDRH intends to use in assessing if a 510(k) submission can be accepted for review. FDA’s current 510(k) Refuse to Accept (RTA) policy includes an early review of criteria and the agency will inform the submitter within the first 15 calendar days after receipt of the submission if it is administratively complete, or if not, what the missing element(s) are.

Most of the guidance is made up of checklists in its appendices, which clarify the necessary elements and contents of a complete 510(k) submission.

CDRH also clarifies that the new policies regarding the factors to consider when determining if a change to an existing device is appropriate for submission through the Special 510(k) pathway will be operationalized immediately.

“However, we recognize and anticipate that both FDA and industry may need up to 60 days to operationalize the associated updates to the 510(k) RTA guidance. As a result, if a 510(k) is received by the FDA before or up to 60 days after the publication of this guidance and does not include all criteria necessary to meet a minimum threshold of acceptability as outlined in the updated RTA guidance, the FDA may decide not to refuse to accept,” the agency adds.

FDA also says: “Until November 13, 2019, once FDA has determined a submission is appropriate for review as a Special 510(k) as described in the Special 510(k) Program guidance, and for all other 510(k) submission types, FDA intends to utilize the prior final RTA guidance to assess whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.”

The Special 510(k) Program

The Abbreviated 510(k) Program

Format for Traditional and Abbreviated 510(k)s

Refuse to Accept Policy for 510(k)s

Webinar - The Special 510(k) Program: Final Guidance


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