News about GMP/cGMP


CDRH works on blending ISO 13485 with 21 CFR 820

We have already reported about the intention of the US FDA/CDRH to changing its quality system requirements for medical device manufacturers and utilise the International Organisation for Standardization (ISO) updated quality management standard, 13485:2016. Obviously the intention has already been put into action.

This was one hot topic at the 12th MedTech Conference, which took place in Philadelphia from September 24 to 26, 2018. William Maisel, Chief Medical Officer of the CDRH, revealed that the agency's proposed plans to blend together certain provisions of 21 CFR Part 820 with ISO 13485 through new rulemaking are already well on their way.

According to RAPS, CDRH is currently mapping out the differences and similarities between the two systems in their approach to auditing MD quality management systems. Maisel already came up with some numbers:

there is roughly a 95 % overlap of the two systems. The 5 % that are not matching include

  • medical device reports,
  • the Medical Device Single Audit Program (MDSAP) and
  • unique device identification.

CDRH intends to enter its revised quality system regulation already by April 2019. This news raised some concern in the audience. Maisel stressed that there will be a public comment period after each step in the process to adopt the rule proposed in May.


RAPS: News

FDA: Proposed rule