USA – FDA finalizes contentious guidance on third party 510(k) reviews

  • FDA formalized guidance on its 510(k) Third Party Review Program this week after a consultation that saw some patient and industry groups criticize varying aspects of the policy allowing some manufacturers to be accredited by outside reviewers.​ The program is designed to enable faster 510(k) decisions and free up FDA to focus on reviewing higher risk devices. 
  • The final guidance issued Wednesday hews closely to the partly disputed draft, with the most common change being the adoption of 3P510k, rather than 3P, as the abbreviation for the program. FDA did acquiesce to the pushback in some areas, for example by clarifying that review organizations should do assessments equivalent to those carried out by the agency.
  • Other changes include a slight softening to FDA’s opposition to subcontracting by review organizations and the unpacking of the term “forum shopping” to explain companies cannot send the same 510(k) submission to multiple review organizations.​..