USA – Senators urge FDA to clarify difference between servicing, remanufacturing

  • A bipartisan pair of senators is urging FDA to provide details on its forthcoming draft guidance on the difference between medical device servicing and remanufacturing in a new letter to the agency.
  • Medical device remanufacturers perform maintenance activities that « significantly change » the safety, performance or intended use of a product, while servicers « provide preventive or routine maintenance » to a used device to return it to the safety standards of its original intended use. In its recently published fiscal year 2020 guidance priority list, the agency placed the development of draft guidance on the subject on its A-List, indicating FDA intends to publish it by next September.
  • Sens. Elizabeth Warren, D-Mass., and Bill Cassidy, R-La., write while they are « pleased FDA plans to issue guidance » to clarify the issue, the lack of data on firms that perform medical device servicing may hinder regulatory efforts to oversee the sector. The agency does not require servicers, who face fewer regulatory requirements than remanufacturers, to register ​with the agency, but FDA estimates the number of servicers in the United States to be between 16,520 and 20,830…