Regulatory Focus™ > News Articles > Filing Review Process to See Changes Under Proposed CDRH Guidance

Filing Review Process to See Changes Under Proposed CDRH Guidance

Posted 30 July 2012

The US Food and Drug Administration (FDA) on 30 July released new draft guidance aimed at reducing the variability and subjectivity of when premarket applications (PMAs) submitted to the Center for Devices and Radiological Health (CDRH) are deemed to be "administratively complete."

The draft guidance, Acceptance and Filing Review for Premarket Approval Applications, is particularly aimed at "assuring the consistency of our acceptance and filing decisions," FDA explained in its Federal Register notice.

The guidance, if adopted, would apply to both PMA's and panel-track PMA supplements reviewed at CDRH.

FDA said the newly redesigned process would, "provide a more efficient approach to ensuring that devices that have a reasonable assurance of safety and effectiveness reach patients as quickly as possible," by introducing two defined categories: acceptance criteria and filing criteria.

Acceptance criteria is characterized by a pre-review process in which FDA will notify an applicant if any administrative elements-are all sections accounted for, is the applicant's information complete, etc.-are missing from an application.

Filing decisions are looked at after a determination of administrative completeness is made, with CDRH officials checking the consistency of data relative to the protocol, final device design and proposed indications, among other considerations.

While the draft guidance does make some changes, FDA said it was "not significantly different" from an earlier 2003 guidance document of the same name. The largest change comes in the form of the differentiation of "filing review questions," which are now separated into the "acceptance" and "filing" criteria to better leverage agency resources and expedite the initial review process.

Comments on the draft guidance are due by 14 September 2012.

Read more:

Acceptance and Filing Review for Premarket Approval Applications


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