FDA Transition to ISO 13485:2016

In Spring 2018, FDA announced it intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016.

See https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201804&RIN=0910-AH99

At a recent MDSAP meeting FDA provided an update on its intention.


FDA estimates it will issue the proposed rule in the Fall 2019.

FDA recognizes the significant impact for implementation. For example:

  • Training on ISO 13485 requirements, interpretation, best practices, etc. to CDRH staff and ORA investigators and compliance officers
  • Changes to the inspection model (QSIT)
  • Revisions/updates to numerous documents
  • Changes to IT systems

FDA suggests the transition period will likely be a few years.