The U.S. FDA has extended the commentary period for feedback regarding its December workshop to differentiate between medical device servicing and remanufacturing by one month. HTM professionals, independent service organizations, and original equipment manufacturers can now comment on the workshop, as well as its associated white paper, Evaluating Whether Activities Are Servicing or Remanufacturing, until February 25.
December’s public workshop—titled “Medical Device Servicing and Remanufacturing Activities” and held in Gaithersburg, Md., over a two-day period—was organized to help the agency gather feedback for a future draft guidance, something discussed in the agency’s May 2018 servicing report. Follow these links for 24×7 Magazine’s inside look at day one and day two of the FDA’s workshop, as well as webcasts of the event.
“The discussions at the workshop and comments received in the docket will be considered when developing draft guidance as noted in the ‘Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices’ (‘FDA Report on Device Servicing’) in accordance with section 710 of the FDA Reauthorization Act of 2017,” FDA officials said in late 2018.
To submit a formal comment regarding medical device servicing and manufacturing, click here.