The FDA issued new recommendations for improving the 510(k) medical device review process by installing a pre-review assessment that would check applications and reject submissions dubbed incomplete.
The proposal is one of the FDA’s attempts to make good on the promises it made to the medical device industry in the latest iteration of the Medical Device User Fee & Modernization Act. The federal watchdog agency vowed to streamline its application review process in exchange for a doubling of fees that companies pay when submitting for review.
"FDA agreed to performance goals based on the timeliness of reviews," the agency wrote in the new proposal. "Acceptance review therefore takes on additional importance in both encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions."
The agency is eager to improve its medical device application review times in order to meet the goals it agreed to in MDUFMA III, which President Barack Obama signed into law last month.
Industry stakeholders and FDA representatives came to terms on a tentative agreement early in February to double the user fees medical device companies pay for agency review, from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.
The FDA aims to introduce a new pre-review assessment that will evaluate specific aspects of each application and inform the submitted within 15 calendar days whether the submission is "administratively complete" or else identify the missing factors.
The pre-review will not consider quality of clinical data or questions of submission quality, but will stick to purely to "objective criteria," the agency wrote.
The FDA’s existing protocol for 510(k) refusal "deals largely with administrative elements but it does not address specific content that is essential for 510(k) review," according to the agency. "As a result, FDA accepts many inadequate submissions for review and FDA staff invests significant time in constructing extensive letters requesting all of the additional information needed to conduct a substantive review."
The agency provided an early version of the new checklist it plans to use to assess applications, which includes basic criteria such "Submission contains table of contents" and "All pages of the submission are numbered," as well as noting the inclusion of engineering drawings and identification of predicate devices.
Missing 1 or more organizational elements, such as the table of contents or page numbers, will not generally result in a a "refuse to accept" decision, the FDA noted, but details outlined in the checklist’s "Elements of a Complete Submission" area are individually grounds for rejection.
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