FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020)

[Ajit Basrur]

The US Food and Drug Administration has identified several final rules, guidances and other actions the agency plans to pursue as part of its Spring 2020 Agency Rule List, including revised quality standards to align with ISO 13485:2016

See View Rule

 

[Ajit Basrur]

Update:

The US Food and Drug Administration has selected February 2021 as the latest target date for releasing a draft of its QSR.

View Rule (reginfo.gov)

 

[Kuldeep Singh]

Hello Ajit basrur,

Can you help me to understand this , From Feb 2021, FDA now using ISO 13485:2016 rather than 21 CFR 820?? Please guide if i am wrong.

As we are ISO 13485 certified company and plan to implement 21 CFR 820. May this information will help us.

 

[Watchcat]

Update:

The US Food and Drug Administration has selected February 2021 as the latest target date for releasing a draft of its QSR.

Where did you get this information? The link just shows the Unified Agenda, back when they were aiming for this fall.

 

[Watchcat]

Hello Ajit basrur,

From Feb 2021, FDA now using ISO 13485:2016 rather than 21 CFR 820??

This has been the subject of wild rumors for 2-3 years now,, but all the best sources I can find indicate that FDA most likely plans to revise the QSR to be more consistent with ISO 13485:2016. However, nothing will be known until FDA releases a draft (probably of a Proposed Rule). When it does, it will undoubtedly open a public docket on regulations.gov, and accept comments on the draft for 2-3 months. It will probably receive more than a few (heh). How long it will take to review those comments, no one can say. What it will do after it reads them all, no one can say. The most common next step is to finalize the Rule, addressing whatever comments it felt like addressing, however it felt like addressing them. But every now and then, upon reading all the comments, it decides it needs to rethink the whole idea.

 

[Ajit Basrur]

Hello Ajit basrur,

Can you help me to understand this , From Feb 2021, FDA now using ISO 13485:2016 rather than 21 CFR 820?? Please guide if i am wrong.

As we are ISO 13485 certified company and plan to implement 21 CFR 820. May this information will help us.

Yes, Watchcat has provided the right response. To add from my side, if you see the link I forwarded, the stage is NPRM that stands for Notice of Proposed Rulemaking. This is the first public step in the notice and comment rulemaking process is for FDA to issue a proposed rule. Its still a long way to go before a Final Rule is published. See this link for The Rulemaking Process (federalregister.gov)

So for you, continue with the ISO 13485:2016 and if you are in US, or supply medical devices to US, follow the 21 CFR Part 820.

 

[Watchcat]

the link I forwarded, the stage is NPRM that stands for Notice of Proposed Rulemaking. This is the first public step

I think this has been included in the Unified Agenda for a couple of years now, maybe longer, with the deadline for the Proposed Rule having been pushed forward numerous time. This is one of a number of efforts that struck me as cans FDA was kicking down the road...I though maybe because it was trying to hold out for a political climate more likely to be supportive of what it wanted to do.

Given that the new date suggests FDA may publish a Proposed Rule within weeks of Inauguration Day, perhaps my instincts were on target. If so, we may see FDA issue a lot of long-discussed, but never issued, initial and final guidances and rules during the first and second quarter of this year.