Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot
Executive Summary
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.
You may also be interested in...
Draft Guidance Doc From FDA Details Lab Accreditation Pilot
The US FDA detailed its proposed approach to the Accreditation Scheme for Conformity Assessment in a new draft guidance document. The ASCA will allow accredited labs to certify that manufacturers meet international conformance standards, which the agency hopes will help streamline the device approval process.
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.
Proposed FDA Guidance Would Provide Alternate Route For 510(k) Applications
US FDA has proposed new requirements for its abbreviated 510(k) program that could help certain sponsors get clearance for their products without having to compare to predicate devices.