Medical device manufacturers puzzling over FDA reporting and recordkeeping requirements, the draft guidance issued on July 11, 2013 will come as a welcome insight into FDA’s current thinking on this issue and some practical advice for completing medical device reports (MDR) submitted to the agency in regard to certain device-related adverse events. Comments on the draft guidance may be made at any time but are requested by October 9, 2013. The draft is available on FDA’s website at http://www.fda. gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359130.htm.

The guidance applies only to medical device manufacturers, including foreign manufacturers and US manufacturers of medical devices that are not cleared or approved in the US, but which are exported to foreign locations. However, the draft includes an Appendix A of summarized requirements applicable to user facilities, importers, and distributors because manufacturers may receive information about MDR reportable events from these entities.

The term "manufacturer" includes persons who repackage or otherwise change the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture; persons who initiate specifications for devices manufactured by a second party for subsequent distribution by the person initiating the specifications; and persons who manufacture components or accessories that are medical devices and that are (1) ready to be used and are intended to be commercially distributed and intended to be used as is, or (2) processed by a licensed practitioner or other qualified person to meet the needs of a particular patient. Further, any person who reprocesses a single use device for reuse in human beings becomes the manufacturer of the device and is subject to all the requirements applicable to the original manufacturer, including the requirements of the MDR regulation [69 Fed. Reg. 7490].

At present, manufacturers of medical devices cleared for marketing in the United States are required to:

  • Report to FDA any MDR "reportable events" medical device involving their medical devices [21 CFR §803.10(c) and §803.50];
  • Develop, maintain, and implement written procedures for the identification and evaluation of all adverse medical device events to determine whether the event is an MDR reportable event [21 CFR §803.17], and
  • Establish and maintain complete files for all complaints concerning adverse medical device events [21 CFR §803.18].

"MDR reportable events" are events of which that manufacturers become that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur [see 21 CFR §803.3].

MDR submissions are made using FDA Form 3500A (MedWatch) or an electronic equivalent approved by FDA. The guidance provides useful advice on completing the form, including clarification about the information that must be included in the report, when MDR reports must be submitted to FDA, how to evaluate complaints received by the manufacturer, and an explanation of special considerations for manufacturers of medical devices used in clinical trials.

Interested parties may also consult FDA’s other guidances issued related to medical device reporting requirements, including:

  • Medical Device Reporting - Alternative Summary Reporting (ASR) Program.
  • Medical Device Reporting - Remedial Action Exemption; Guidance for FDA and Industry [RAE Guidance Document].
  • Needle sticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers [Needle sticks].
  • MDR Guidance Document No. 1 - IOL - E1996004 [IOL Exemption].
  • Variance from Manufacturer Report Number Format (Variances Nos. 1-4) - [Report Number Variance].
  • Variance from Manufacturer Report Number Format - No. 5 [Report Number Variance 5].
  • Draft Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting.
  • Draft Guidance for Industry and FDA Staff: Medical Device Reporting for Manufacturers (superseded by this guidance when final).