Developing, maintaining, and implementing written MDR procedures

Aug 25, 2015 | News

With the issuance of the Draft Guidance  FDA Notification and Medical Device Reporting for LDT late last year, there have been a number of clarifications in its first major attempt to update the Medical Device Amendments (MDA) of the landmark Federal Food, Drug, and Cosmetic Act (FD&C Act) in years.

As we’ve covered in previous blog posts, one major revision is the FDA’s new approach to laboratory developed tests (LDTs) after determining that its position had not evolved as rapidly as the industry’s growing use of LDTs. Until recently the agency had not categorized and overseen LDTs the same way as traditional in vitro medical devices. With the growing concern regarding patient safety and the increased risk that comes with the increased use of LDTs, the FDA is now declaring any clinical laboratory that produces and sells LDTs is a medical device manufacturer – the same as any company that manufactures and sells stents, catheters, and cardiovascular monitoring equipment.

According to the Draft Guidance, clinical laboratories manufacturing LDTs for clinical use must now develop, implement, and maintain written Medical Device Reporting (MDR) procedures just like any other medical device manufacturer.  These procedures should include internal systems that provide clear instructions for the timely and effective identification, communication, and evaluation(including cause)  of any event that may be subject to MDR requirements. In addition, labs producing LDTs must also develop a standardized review process or procedure that will help determine when an event meets MDR reporting criteria; and, as a medical device manufacturer, they are required to establish and maintain MDR event files to be utilized in producing any necessary MDR reports. Finally, those clinical labs must make sure they get those MDR reports into the hands of the FDA in a timely manner per specific FDA timelines.

If you’re a clinical laboratory producing your own proprietary LDTs and are unsure of how the draft FDA guidelines might affect your business, download a free copy of Medical Device Reporting for Manufacturers for reference or contact us by emailing us or calling at 508-231-8842.