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Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers. Notification; order granting alternative.

08:00 EDT 17th August 2018 | BioPortfolio

Summary of "Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers. Notification; order granting alternative."

The Food and Drug Administration’s (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program." This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).

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This article was published in the following journal.

Name: Federal register
ISSN: 0097-6326
Pages: 40973-85

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Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

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