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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 to allow outside experts to access data with research value in a way that would protect patient privacy and the commercial investments of product sponsors. In initial comments, however, the device industry questioned FDA’s legal authority to make public such masked clinical data

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