Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers." This final guidance document is intended to help manufacturers better understand and use the VMSR Program. This guidance describes and clarifies several aspects of the VMSR Program, including the FDA's approach to determining the eligibility of product codes for the program and the conditions for submitting medical device reports (MDRs) for device malfunctions in summary format under the program.
Abstract as published in the Federal Register.
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