Anon,
You will find the list of recognised standards here (which you are probably aware): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Generally if the US FDA has put a transition period (grace period) on a standard, they will put this in the individual standard called "Transition Period." Some standards have a date, some have some explanation, and others do not have anything. So as stated, if there is no Transition Period, then it is presumed to be effective at that time. Typically there is some period of time like 1 or 2 years where reviewers or inspectors see companies needing to transition. It should be noted, regardless of a transition period stated by a regulatory agency (United States or others), a company should have a regulations, standards, and guidance process defined (a procedure) within their quality system to review newly published regulations or standards, complete an impact, and document if the company needs to implement a transition period,
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Mar-2023 10:10
From: Edwin Bills
Subject: FDA recognized standard- Grace period.
For a specific example of a grace period FDA Recognized ISO 14971:2019 within days of its publication and published it in their Recognized Standards database. On the Recognition page it then stated it would recognize the 2007 edition for product submissions until December 25, 2022-a three year transition. FDA understands that a product under development under a previous edition would be difficult to change to the new edition on the fly, and thus allowed the previous edition. HOWEVER, this is on a case-by-case basis as some standards may have need for some immediate updates for products under development. And as in the case of ISO 10993-1 a few years ago, FDA published a replacement table for testing as they had some concerns.
The bottom line is to read the Recognition page in detail to make sure you understand the extent of recognition and the date of withdrawal for the previous edition.
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Edwin Bills MEd, BSc, ASQ Fellow, CQE, CQA, CQM/OE, RAC
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
Original Message:
Sent: 14-Mar-2023 14:22
From: Anne LeBlanc
Subject: FDA recognized standard- Grace period.
Specifically about where to look...
In the US, the database of recognized consensus standards:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
In the EU, standards harmonisation lists for the applicable regulation(s) and/or directive(s):
https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en
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Anne LeBlanc
United States
Original Message:
Sent: 14-Mar-2023 13:43
From: Dan O'Leary
Subject: FDA recognized standard- Grace period.
In the US, generally, FDA recognized consensus standards do not have a grace period.
FDA recognized consensus standards are not requirements. A manufacturer could use them in a pre-market submission through a Declaration of Conformity. In some cases FDA will declare an overlap between two versions of a standard and would accept a Declaration of Conformity to either version. Eventually, the overlap ends.
If you have a cleared, for example, device based on a standard and the standard changes, you do not need to update the device.
The situation in the EU is different. There, state-of-the-art means that you should update the device when the standard changes.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 14-Mar-2023 12:42
From: Anonymous Member
Subject: FDA recognized standard- Grace period.
This message was posted by a user wishing to remain anonymous
Where do I see the grace period of a newly recognized standard (FDA)?
I am looking for the Grace period for 15223-1 but I want to understand in general where to look for it.
in the US and the EU.