Draft Guidance for Industry and Food and Drug Administration Staff
Medical Device Reporting for Manufacturers
This guidance document is being distributed for comment purposes only.
Document issued on: July 9, 2013
This draft guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. These requirements are contained in our Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), part 803, as authorized by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). References to FDA regulations and Federal Register documents, as well as cross-references within this guidance document, are hyperlinked for your convenience.
Read the Section 519 of the FD&C Act
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in guidance documents means that something is suggested or recommended, but not required.
What is the purpose of the MDR regulation?
The MDR regulation provides a mechanism that allows us (the FDA), as well as you (the device manufacturer), to identify and monitor adverse events (deaths, serious injuries and malfunctions) involving your medical devices. The goal is to detect and correct problems in a timely manner. The requirements of the MDR regulation are enforced under the authority of the FD&C Act. The enforcement mechanisms include seizure, injunction, civil money penalties, and criminal prosecution.
The MDR regulation also includes adverse event reporting and recordkeeping requirements for medical device user facilities (e.g., hospitals, nursing homes) and importers of medical devices, as well as recordkeeping requirements for medical device distributors.
Manufacturers, including foreign manufacturers, of medical devices cleared for marketing in the United States are required to:
- Submit to us reports of MDR reportable events 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] (for related information, see sections 2.10 and 3.1 of this guidance); and
- Establish and maintain complete files for all complaints concerning adverse medical device events [21 CFR 803.18] (for related information, see section 3.2 of this guidance).
For manufacturers, “MDR reportable events” are events that manufacturers become aware of 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] (see Chapter 2 of this guidance document for a description of “serious injury” and “malfunction” and information for determining when a device malfunction must be reported to us as an “MDR reportable event”).
Electronic Medical Device Reporting (eMDR)
Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff
Document issued on: February 13, 2014
- Read more about eMDR here
Read the Appeals Court (Tenth Circuit) Decision for TMJ Implants, Inc. v. US DHHS
- Legal analysis
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Download 21 CFR Part 803 in PDF
Last Updated: 2015-07-26
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