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FDA extends comment period on guidance for diagnostic devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 24, 2007

In our September 3 issue we told you about draft FDA guidance for device manufacturers who develop In Vitro Diagnostic Multivariate Index Assays (IVDMIA). That guidance addresses the definition and status of pre- and post-market requirements for these devices including when the FDA requires pre-market notification submissions (510K) and applications for pre-market approval.

On September 17, the FDA announced it is reopening the comment period for this draft guidance. Comments can be submitted until October 17, 2007. An earlier version of the draft guidance was introduced in September 2006 with a 90-day comment period that was extended to 180 days. Additionally, a February 2006 public meeting was held concerning the guidance.

The FDA's federal register notice about the re-opened comment period indicates that because of the extensive comment period already provided on the issue, the FDA had only assigned a 30-day comment period for the most recent version of the draft guidance issued in July 2007. The extended comment period is being provided in response to requests from "in vitro diagnostic device stakeholders" who claimed the 30-day period wasn't enough time to evaluate and respond to the current draft, the FDA said.

Click here to read the FDA notice of re-opened comment period. Click here to read the draft guidance issued in July.

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