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FDA Issues Guidance Document On Benefit-Risk Determination, De Novo Decisions

Tuesday, March 27, 2012   (0 Comments)
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The FDA issued a new guidance document this week designed to clarify the principal factors CDRH will consider when making benefit-risk determinations in premarket approvals (PMAs) and de novo classifications.

The document, "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications" is another part of the plan CDRH announced last year when it undertook a review of the premarket review process.

The FDA noted that it would "increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMAs and the decision summary review memos for de novo decisions."

To view this new guidance document, click here.

MDMA continues to highlight the importance of not only issuing new guidance documents, but ensuring that they are implemented in a reasonable and predictable manner.