FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

• By: Staff Editor
• Date: March 08, 2017
• Source: https://www.fda.gov

FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

The US FDA has recently finalized its 2013 draft guidance on the Medical Device Reporting (MDR) requirements for manufacturers. The guidance supersedes the 1997 MDR guidance document. The finalized guidance document addresses the reporting and recordkeeping requirements for device related adverse events and malfunctions.

The guidance requires the submission of three types of MDR reports. These include 30-day (initial) reports [21 CFR 803.10(c). 803.20 and 803.50], 5 - day reports [21 CFR 803.10(c), 803.20 and 803.53] and supplemental reports [21 CFR 803.10(c) and 803.56]. It further details the required information to be included in the each kind of report and the necessary time frame for submissions.

FDA Guidance Key Areas

The final guidance offers clarification on several key issues related to medical device reporting into a question and answer format. Some of the key questions answered in the guidance are related to:

• Manufacturer reporting requirements
• Requirements for developing and implementing written MDR procedures, maintaining MDR files and records, and information subjected to public disclosure.
• Specific issues and situations such as delay in surgery, expected life of the device, device labeling, devices under Investigational Device Exemption (IDE), etc.
• Questions concerning completion of the MDR report including patient information, adverse event or product problem, for use by user facility, and much more.

The guidance also addresses basic requirements for user facilities, importers and distributors for device manufacturers to ensure FDA regulatory compliance.