Final Guidance on Medical Device Reporting Issued by FDA
On November 8, 2016, the Food and Drug Administration (FDA) issued a final guidance on Medical Device Reporting for Manufacturers. The draft guidance was issued on July 9, 2013.
This new guidance document is intended to assist medical device manufacturers in meeting applicable reporting and recordkeeping requirements for device-related adverse events and certain malfunctions. There have been numerous changes to the Medical Device Reporting (MDR) requirements since the Federal Food, Drug, and Cosmetic Act first described them and MDR regulations became effective more than 20 years ago. The FDA’s final guidance on MDR for manufacturers updates its policy and clarifies the agency’s interpretations of the regulatory requirements under 21 CFR part 803. This new guidance supersedes the 2013 draft guidance and the 1997 manufacturer MDR guidance document.
The new guidance includes an explanation of the following MDR-related topics, which are not all inclusive:
- Manufacturer Reporting Requirements
- Written Procedures, Recordkeeping and Public Disclosure
- Specific Issues and Situations
- Questions Concerning Completion of the MDR Report
- Appendix A.1 – Basic Requirements for User Facilities
- Appendix A.2 – Basic Requirements for Importers
- Appendix A.3 – Basic Requirements for Distributors
The guidance is written in a question-answer style, providing detailed answers to questions relevant to the interpretation of 21 CFR part 803. Among the topics addressed by the guidance are the following:
- Every manufacturer (unless exempted) must develop, maintain and implement written MDR procedures that directly address all requirements of the MDR regulation.
- All complaints, which may be received from a number of sources (e.g., written correspondence, email notification, sales representative reports, service representative reports, scientific articles [literature], internal analyses, and legal documents), must be reviewed and evaluated to determine whether the complaint represents an MDR-reportable event. Complaints involving adverse events may not require reporting if the complaint is determined to be erroneous. Documentation must be maintained to support the decision for not reporting the event.
- Manufacturers must submit reports for adverse events involving their devices that appear in reports in medical or scientific literature. Manufacturers must be sure to obtain a reporting exemption from the FDA by written request on company letterhead with an original signature.
MDR follow-up investigations should involve a “good faith effort” to obtain information, and documentation of evidence of the attempts must be maintained. In situations where a manufacturer is unsure as to whether or not to report, err on the side of reporting.
If an MDR guidance document is required, there are three types:
- A 30-day (initial) report.
- A 5-day report (for events that require remedial actions to prevent an unreasonable risk of substantial harm to the public health or events for which the FDA requests such a report to be submitted).
- A supplemental or follow-up report that may be needed to provide information to the FDA that was not available during the time the initial 30-day or 5-day report was submitted.
The FDA’s guidance documents, including the one mentioned in this blog, do not establish legally enforceable responsibilities. Instead, guidance documents describe the FDA’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 FDA guidance documents means that something is suggested or recommended, but not required.
If you need any assistance with implementing or interpreting this guidance document, relating to Medical Device Reporting, contact ICON at www.iconplc.com/devices for more information. Our medical device experts have direct experience in the application of the recommendations contained within this document. We can assist in determining the process for submitting a report and conducting an investigation, and whether the event is reportable. We also have experience assisting manufacturers with developing and implementing the required procedures. We highly recommend putting a robust process in place to avoid a 483 observation or Warning Letter.
Melvin G. Fletcher III
ISO 13485, CMDR, and MDD/CE Marking Certified Lead Auditor
Cynthia Nolte, Ph.D., RAC
Director, Regulatory Affairs