News · Right to Repair

What Is The FDA Docket Really Looking For?


Posted March 22, 2016 on the MedWrench Blog

In today’s edition of the MedWrench blog I want to touch on the recent FDA Docket requesting information and comments on the medical device industry and healthcare community that “refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices including radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)”. Essentially the FDA wants information concerning the “third-party entity or entities” because of expressed concerns about the “quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments.” This request for information came as a surprise to the industry and left many parties confused as to what the outcome of this request would/could be.  

After reading over the docket and sitting in on a teleconference that was a “preliminary call to discuss key points and gain input”, I believe the docket can be taken at face value. The teleconference included AAMI President and CEO Mary Logan, ECRI Institute staff members and several representatives from third-party and independent service organizations. It appears the FDA is simply trying to collect information to get a better understanding of third-party entities and the details concerning what exactly it is they do. Initially, I believe this request for information by the FDA may have been worrisome to the third-parties and could have been viewed as a legitimate threat to their industry.  However, as with all things in life, it is never good to assume. My personal opinion is that the 3rd party entities do not need to come off as being defensive, but rather should give the exact information requested by the FDA. No more, no less.

For those wanting to educate themselves further on this matter, TechNation is hosting a “Special FDA Webinar for Medical Equipment Sales and Service Industry”. This webinar will take place on March 31, 2016 at 2:00pm EST and will feature an Expert Panel from all segments of the industry (hospital technicians/engineers, ISO’s, third party parts/equipment providers, Associations, etc.) to help inform you and what your next steps should be. Click here to register today!

Other opportunities concerning this matter include a Special FDA Panel Discussion for the Medical Equipment Sales and Service Industry at the MD Expo in Dallas on April 21-23, 2016. The MD Expo will feature a special meeting hosted by expert panelists to discuss the FDA docket that is open for comments concerning the service, maintenance, refurbishment, and alteration of medical devices, by third-party entities, as well as challenges third-party entities face in maintaining or restoring devices to their original or current specifications. These devices include endoscopes, and radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the FD&C Act. Time is of the essence, deadline for comments on the FDA website is MAY 3, 2016.

CLICK HERE to read the FDA Docket.

CLICK HERE to for the details on the Special FDA TechNation Webinar.

To Be Held: Online March 31, 2016 @ 2:00 pm EST

CLICK HERE to learn more about the Special FDA Panel Discussion.

To Be Held: At MD Expo in Dallas Texas on April 21-23, 2016