FDA’s Refuse to Accept Policy for 510(k)s and Acceptance Review Process for PMAs

Erika Huffman, M.S., RAC

Medical Research Manager

NAMSA

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Overview What is the Acceptance Review? Most Frequently Missed Criteria (510k) Commonly Missed Criteria (PMA) What Happens Next?

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What is the Acceptance Review?

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The Acceptance Review is a “pre-review” step in FDA premarket review process

Traditional, Special, Abbreviated 510ks Refuse to Accept Policy

Original PMAs, Panel-track PMA Supplements Acceptance Review

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The Acceptance Review is also a quality control process for submissions

Limited to “general completeness” of submission Checklist of required information

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After a submission is accepted by the FDA’s Document Control Center (DCC), the Acceptance Review will occur within the first 15 calendar days of FDA review cycle

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Most Frequently Missed Criteria (510k)

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Shelf Life Proposed shelf life/expiration date explicitly stated Summary methods used to establish that device

performance is not adversely affected by aging Or, rationale for why the storage conditions are not

expected to affect device safety or effectiveness

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Biocompatibility Patient-contacting device components and

materials identified Biocompatibility assessment of patient-contacting

components provided

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Administrative 510(k) Summary or Statement provided Prior submissions (for same device) identified Indications for Use Complete Standards Data Report (FDA Form

3654) for each standard referenced submission Engineering drawings, figures, schematics

provided 510k number provided for each

component/accessory with prior clearance

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Commonly Missed Criteria (PMA)

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Manufacturing

Device Manufacturing information provided

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Supporting Data Full test reports provided Final versions of clinical protocols provided Results of all statistical analyses identified in the

protocol(s) included

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Administrative

All required FDA forms included

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What Happens Next?

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Accepted Notification of successful

acceptance review FDA review clock started FDA may request information

required as part of acceptance review during subsequent review process

Rejected Notification of unsuccessful

acceptance review Submit additional information

under originally issued submission number

Repeat Acceptance Review process

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