Article preview from "The Gray Sheet"- August 06, 2012
A draft guidance document designates “acceptance” criteria that when not met by a PMA will allow a reviewer to send the submission back to the sponsor more quickly.
Article preview from "The Gray Sheet"- August 06, 2012
FDA issued a draft guidance document
July 30 intended to establish a quicker mechanism for reviewers to weed out certain deficient device pre-market approval applications, with the aim of focusing the agency’s limited review resources on applications that meet at least bare-minimum requirements for completion and data validity.
The draft guidelines, “Acceptance and Filing Review for Pre-Market Approval Applications,” update FDA’s 2003 PMA filing guidance. The earlier document includes a set of basic criteria that a submission needs to satisfy before the agency will officially file the application and begin pre-market review.
The new draft includes essentially the same criteria as the 2003 version but breaks them into two distinct checklists: acceptance criteria and filing criteria.
The newly designated acceptance criteria create a shortcut for review staff to determine whether a PMA submission is basically complete, includes valid data and appears to address questions previously raised by FDA. A reviewer can send an application back to a sponsor as not accepted within 15 days without having to look through other components of the filing checklist.
Continued...
To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to "The Gray Sheet".
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments