Minor Updates To US FDA Guidances Aim To Clarify What PMA, 510(k) Applications Should Include
Executive Summary
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.
You may also be interested in...
US FDA Now Requires GCP Statement For Foreign Trial Data
A regulation finalized last year kicks in today requiring companies to either include along with US FDA submissions a statement affirming Good Clinical Practice compliance for any data collected outside the US, or get a waiver.
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.
More Leeway For Reviewers In Updated 510(k) 'Refuse-To-Accept' Policy
An updated 510(k) “refuse to accept” guidance document gives FDA staff more opportunity to work with sponsors to smooth out product submissions without repeatedly halting and restarting the review clock with RTA determinations.