Interactive Review May Be Revamped In 2012 User Fee Agreement

Article preview from "The Gray Sheet"- May 2, 2011

Acknowledging the shortcomings of the program, FDA is considering improving the interactive review process as part of its negotiations with industry on reauthorizing the medical device user fee program.

Interactive Review May Be Revamped In 2012 User Fee Agreement

Article preview from "The Gray Sheet"- May 2, 2011

Acknowledging the shortcomings of the program, FDA is considering improving the interactive review process as part of its negotiations with industry on reauthorizing the medical device user fee program.

Interactive review describes a policy of informal communications between FDA and sponsors during pre-market reviews, when possible, in lieu of official requests for additional information that eat up more time. It was established as an official policy in the 2007 device user fee agreement in conjunction with the elimination of complex mid-review-cycle goals. (See " New Interactive FDA Device Review Is Significant, But Goes Only So Far " – "The Gray Sheet" Oct. 1, 2007.)

But both FDA and industry now admit: interactive review is not working as planned.

For instance, interactive review is only employed in about one-third of 510(k) reviews, according to FDA data.

A careful look "reveals a number of challenges with the program as designed and as implemented," FDA said in meeting minutes from a March 30 user fee negotiation meeting, released to the public last week.

Continued...

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