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Regulatory Briefs: Comment Period For Masked Data Release Reopened; Studies On 510(k), Post-Market Programs

FDA has reopened the comment period for its proposal to release masked trial data. The HHS Office of Inspector General released a study on FDA classification of class III pre-amendment devices. More regulatory news.

In response to requests, FDA has added 30 days to the public comment period for its June 4 proposal to release masked and/or de-identified nonsummary safety and efficacy data from marketing applications. (See Also see "FDA Wants To Release “Masked” Marketing Application Data To Researchers" - Medtech Insight, 10 June, 2013..) The new deadline for submitting comments on the proposal is Oct. 31.

FDA is seeking comments on the concept of making masked and/or de-identified pre-clinical and clinical data from marketing applications available to third parties for independent research. The goal would be...

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