mdi ConsultantsFDA requests your comments!!
With concern about the quality, safety and continued effectiveness of medical devices which have been subjected to continued servicing, maintenance, refurbishment and possible alteration by Original Equipment manufacturers(OEMs) or 3rd party entities, FDA is finally reviewing its policy and is re-approaching the issue. FDA has asked for comments about the Regulations and also wants assistance in defining certain relevant terms.
The main focus of FDA is on 3rd party activities as they may use unqualified person for the job and don’t have proper documentation which might lead to potential public health hazards. FDA also wants to determine the risks associated with the activities when performed by the OEMs. This was of major concern in 1997 with the revised QSR but never made the final regulations. Well, it is back again and the FDA is again looking at this topic seriously.
If you have any comments now is the time to get it in.
Submit either electronic or written comments on the topic by May 3, 2016 to Docket FDA-2016-N-0436. Follow the instructions and Submit electronic comments at Federal eRulemaking Portal.
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No. FDA-2016-N-0436 for “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing and Servicing od Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
? For any assistance or questions or clarification please contact us at [email protected] or use our Contact form. Ref: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments.