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FDA Focuses On Weeding Out Deficient PMAs

A draft guidance document designates “acceptance” criteria that when not met by a PMA will allow a reviewer to send the submission back to the sponsor more quickly.

FDA issued a draft guidance document July 30 intended to establish a quicker mechanism for reviewers to weed out certain deficient device pre-market approval applications, with the aim of focusing the agency’s limited review resources on applications that meet at least bare-minimum requirements for completion and data validity.

The draft guidelines, “Acceptance and Filing Review for Pre-Market Approval Applications,” update FDA’s 2003 PMA filing guidance

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