|Today’s Federal Register describes a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting Program would not apply to importers or device user facilities.|
This announcement 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 Act of 2017 (MDUFA IV Performance Goals and Procedures). These goals include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format. In addition, this proposed program reflects FDA’s findings from a pilot program the Agency conducted to study summary reporting formats for malfunction MDRs.
We welcome your comments and suggestions regarding this proposed program. The comment period will be open for 60 days (until February 26, 2018).
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or email@example.com.
Food and Drug Administration
Center for Devices and Radiological Health
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