Draft Guidance on Medical Device Reporting for Manufacturers - Issued 07/09/13

Earlier last month, FDA released a new draft guidance that addresses many questions and answers pertaining to the sometimes tricky world of medical device reporting for medical device manufacturers. ^(1-4) The draft guidance, “Draft Guidance on Medical Device Reporting for Manufacturers⁽³⁾,” aims to clarify a wide array of requirements of the MDR. It has been over 15 years since the last MDR draft guidance was published by the FDA.^(1-3) Since 1997, industry has seen a variety of “text book” examples of medical device reporting - some good and some bad – and many lessons have been learned.When the draft guidance that was issued on 07/09/13 is final, it will supersede “Medical Device Reporting for Manufacturers” issued in 1997.(^3-4)

Points of Interest / Notes:

⧠ Applies to domestic & foreign medical device manufactures

⧠ Defines reporting responsibilities

- §2., page 4 - 36

- §4.12.1, page 41

⧠ Marketed device that is still in commercial distribution, but no longer is being manufactured

- §4.12.1, page 41

⧠ Manufacturing responsibility example between two firms

- §4.12.2, page 41

⧠ Provides guidance on MDR form completion

- §5., page 38 - 44

- §5.1.2, page 38 (common problems with filling out Form 3500A)

⧠ Requirements for written MDR procedures, records, and files

- §3., page 24 – 7

⧠ Examples of specific issues/situations

- §4., page 28 - 36

The draft guidance is open for public comment for 90 days. If you have appropriate and constructive commentary, make sure your voice is heard by submitting a public comment! Open comments are not left unheard, nor are they left unread. For more information on how to comment, feel free to take a look at my “New Year, New Resolutions⁽⁵⁾” blog from January or visit the Federal Register⁽⁴⁾.

Do you have any questions or comments? Please, leave your feedback!

-RSpelich ^_^

References

1.) FDA. Medical Devices – Medical Devices Reporting for Manufacturers. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094529.htm. Last updated on 08 July 2013. Accessed on 30 July 2013.

2.) FDA. Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359130.htm. Last updated on 08 July 2013. Accessed on 30 July 2013.

3.) DHHS and FDA. Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufactures. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094530.pdf. Last updated on 09 July 2013. Accessed on 30 July 2013.

4.) Federal Register. Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Drug Administration Staff; Availability. Available at: https://www.federalregister.gov/articles/2013/07/09/2013-16395/medical-device-reporting-for-manufacturers-draft-guidance-for-industry-and-food-and-drug. Accessed on 05 Aug. 2013.

5.) Spelich R. Available at: http://rqteam.com/2013/01/new-year-new-resolutions/. Accessed on 05 Aug. 2013.

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