A Promise Kept? FDA Gives Some Leeway On 'Promissory' Statements In Consensus Standards Final Guidance
A final guidance from US FDA details when underlying data or supporting documentation must accompany a declaration of conformity to a consensus standard in a pre-market submission, and it offers a bit more wiggle-room than the agency previously proposed on the prospect of a promissory note pledging future conformance with a standard.
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The agency has republished two guidance documents outlining conditions for when it could not accept a 510(k) or PMA application for review to incorporate regulatory updates. While the changes are minor, FDA hopes they will continue to give sponsors enough detail to reduce the number of applications that get turned away for lack of basic information.
Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot
FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.
A draft guidance from the agency would give companies less leeway on declaring conformance to a voluntary standard as a way to sidestep certain premarket data submission requirements.