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
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."