Medical Device Reporting

FDA Guidance on Medical Device Reporting for Manufacturers has been updated.  The Guidance was originally issued in 1997.  This recent 2016 Edition provides manufacturers with insight into the 21 CFR Part 803 regulation’s requirements.  It is organized as a series of questions and answers.

Medical Device Reporting (MDR) is the methodology for identifying and monitoring adverse events like deaths and serious injuries.  Certain malfunctions of medical devices will also fall into this category.  Not only are manufacturers required to keep such records, but so are facilities where medical devices are in use (like hospitals, nursing homes, and so on).

What are the MDR requirements of Part 803?  This part of the FDA regulations requires submission of “MDR” reports by manufacturers (including non-U.S. companies).  This means such manufacturers will have to develop, maintain, and implement written procedures for identifying and evaluating MDR events.  It also means that records must be kept for all complaints regarding possible MDR applicable situations.

With this type of regulation, there can sometimes be a lack of clarity in the types of events that should or should not be reported.  So this FDA guidance document is really helpful.  It walks through the various questions that can arise from the implementation requirements of the applicable sections associated with the Federal Food, Drug and Cosmetic Act.  So you will have a chance to see what types of issues can be brought up.  And you will see the usual way that the FDA handles each one.

How can you get a copy of this new guidance document, “Medical Device Reporting for Manufacturers”?  Consider using Document Center Inc. for your purchase.  Our notification service is best-in-class, so customers who purchased the original issue in 1997 were informed of both the draft from 2013 and this new edition in 2016.  You can search for and order standards and other compliance documents at our webstore, www.document-center.com.  Here is a direct link to the order page for Medical Device Reporting for Manufacturers.

Document Center Inc. has a number of other services that are particularly useful to medical device manufacturers and others in the industry.  Check in with our staff on our auditing, reporting and company-wide solutions.  You can reach us by phone (650-591-7600) and email (info@document-center.com).  We have been working with compliance information since 1982.  Make us your Standards Experts!