Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are in the process of submitting a Class II medical device 510(k) and we are supporting the initial shelf life expiration dating with accelerated aging dating according to accepted procedures. We plan to extend the  expiration dating when the device is initially released to market. Can the extended expiration dating be based on accelerated aging data or is it required to be real time data? If medical device expiry dating extension is to be based on real time data,where is that stated in the regulations.

I know of no U.S. regulations that specifically address extensions of medical device shelf-life.  Perhaps other Forum members can offer additional insights on that.  Accordingly, it is necessary to consider other FDA precedents to understand FDA's corresponding enforcement approach.

A revealing precedent that I think is particularly useful for the question at hand is that, when a device's expiration date is extended beyond that which is described in a device's 510(k), FDA generally does not require a new 510(k) as long as the same shelf-life test method and protocol described in the 510(k) are employed when extending the shelf life.  This is established in FDA's guidance document for deciding when to submit a new 510(k) for a modified device and has always been honored by FDA in the 510(k)s I've done.

Because of this, we know that a shelf-life extension could indeed be based on subsequent/supplemental accelerated aging results as long the accelerated aging protocol (and I recommend an explanation of the Sponsor's intent to later extend the date based on subsequent accelerated aging data) are described in the 510(k).  But if the 510(k) only included a real-time aging protocol, then shelf-life extensions based on an uncleared accelerated protocol would not likely be accepted by FDA in the absence of corresponding 510(k) clearance.

All this said, be very careful to remember that medical device expiration dates derived via accelerated aging studies are generally considered to be only tentative in nature.  Accordingly, FDA generally requires such tentative expiration dates to be followed up and verified in timely fashion by real-time aging studies.  Consequently, even though FDA will allow expiration dates or extensions based on 510(k)-cleared accelerated aging protocols, those tentative expiration dates are not allowed to be used indefinitely unless backed up by real-time testing.

FDA's medical device requirement for real-time verification of accelerated aging expiration dates is modeled after the drug regulations in 21 CFR 211.166(b).  As far as I know, no analogous device regulations have been promulgated other than those for IVD reagents in 21 CFR 809.10.  Although Part 814 (for PMAs) includes a few brief sections about shelf life and expiration dating, those are not applicable to the question at hand, and so aren't further addressed in this narrative.

Although I know of no device regulations promulgating the tentative nature of expiration dates derived from accelerated aging studies, make no mistake:  FDA's corresponding enforcement approach is well established.  We can see this in some device-specific guidance documents (like those for contact lenses) where FDA echoes this general policy.  Another weighty authority is the FDA-recognized consensus standard ASTM F1980 which also prescribes that real-time aging studies are needed for confirmation of the tentative dates derived via accelerated aging.  And coincidentally, a few weeks ago I just had a call from an FDA Compliance Officer regarding a case in which FDA was preparing to pursue criminal action against a firm where such expiration dating problems were at the forefront of the issue.

So, for any firms still sporting those flashy 5-year expiration dates derived from accelerated studies where it's now more than 5-years after 510(k) clearance without a completed real-time study…beware.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com
© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 13-Dec-2019 14:16
From: Anonymous Member
Subject: Medical Device Expiration Dating

This message was posted by a user wishing to remain anonymous

We are in the process of submitting a Class II medical device 510(k) and we are supporting the initial shelf life expiration dating with accelerated aging dating according to accepted procedures. We plan to extend the  expiration dating when the device is initially released to market. Can the extended expiration dating be based on accelerated aging data or is it required to be real time data? If medical device expiry dating extension is to be based on real time data,where is that stated in the regulations.

Yes, I just posted this on a Friday night.
Yes I'm a regulatory geek.
No, I don't have a life...

Just kidding, I have a very blessed life and wish the same, along with abundant health and prosperity, to all of our Forum members in the coming New Year!

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com
© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 13-Dec-2019 21:11
From: Kevin Randall
Subject: Medical Device Expiration Dating

I know of no U.S. regulations that specifically address extensions of medical device shelf-life.  Perhaps other Forum members can offer additional insights on that.  Accordingly, it is necessary to consider other FDA precedents to understand FDA's corresponding enforcement approach.

A revealing precedent that I think is particularly useful for the question at hand is that, when a device's expiration date is extended beyond that which is described in a device's 510(k), FDA generally does not require a new 510(k) as long as the same shelf-life test method and protocol described in the 510(k) are employed when extending the shelf life.  This is established in FDA's guidance document for deciding when to submit a new 510(k) for a modified device and has always been honored by FDA in the 510(k)s I've done.

Because of this, we know that a shelf-life extension could indeed be based on subsequent/supplemental accelerated aging results as long the accelerated aging protocol (and I recommend an explanation of the Sponsor's intent to later extend the date based on subsequent accelerated aging data) are described in the 510(k).  But if the 510(k) only included a real-time aging protocol, then shelf-life extensions based on an uncleared accelerated protocol would not likely be accepted by FDA in the absence of corresponding 510(k) clearance.

All this said, be very careful to remember that medical device expiration dates derived via accelerated aging studies are generally considered to be only tentative in nature.  Accordingly, FDA generally requires such tentative expiration dates to be followed up and verified in timely fashion by real-time aging studies.  Consequently, even though FDA will allow expiration dates or extensions based on 510(k)-cleared accelerated aging protocols, those tentative expiration dates are not allowed to be used indefinitely unless backed up by real-time testing.

FDA's medical device requirement for real-time verification of accelerated aging expiration dates is modeled after the drug regulations in 21 CFR 211.166(b).  As far as I know, no analogous device regulations have been promulgated other than those for IVD reagents in 21 CFR 809.10.  Although Part 814 (for PMAs) includes a few brief sections about shelf life and expiration dating, those are not applicable to the question at hand, and so aren't further addressed in this narrative.

Although I know of no device regulations promulgating the tentative nature of expiration dates derived from accelerated aging studies, make no mistake:  FDA's corresponding enforcement approach is well established.  We can see this in some device-specific guidance documents (like those for contact lenses) where FDA echoes this general policy.  Another weighty authority is the FDA-recognized consensus standard ASTM F1980 which also prescribes that real-time aging studies are needed for confirmation of the tentative dates derived via accelerated aging.  And coincidentally, a few weeks ago I just had a call from an FDA Compliance Officer regarding a case in which FDA was preparing to pursue criminal action against a firm where such expiration dating problems were at the forefront of the issue.

So, for any firms still sporting those flashy 5-year expiration dates derived from accelerated studies where it's now more than 5-years after 510(k) clearance without a completed real-time study…beware.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com
© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Dec-2019 14:16
From: Anonymous Member
Subject: Medical Device Expiration Dating

This message was posted by a user wishing to remain anonymous

We are in the process of submitting a Class II medical device 510(k) and we are supporting the initial shelf life expiration dating with accelerated aging dating according to accepted procedures. We plan to extend the  expiration dating when the device is initially released to market. Can the extended expiration dating be based on accelerated aging data or is it required to be real time data? If medical device expiry dating extension is to be based on real time data,where is that stated in the regulations.

It is not clear if you are discussing an in vitro diagnostic device. If you are, FDA has recognized CLSI standard EP25-A on Stability Testing of Diagnostic Reagents for instructions on how to perform this testing. 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=30533.
Real time stability testing on three lots of reagents is usually requested by FDA. Extending a reagent stability claim does not require a new 510k but do require documentation to support the new claim during an inspection. 

------------------------------
Christopher Bentsen FRAPS
retired
Redmond WA
United States
------------------------------

Original Message:
Sent: 13-Dec-2019 14:16
From: Anonymous Member
Subject: Medical Device Expiration Dating

This message was posted by a user wishing to remain anonymous

We are in the process of submitting a Class II medical device 510(k) and we are supporting the initial shelf life expiration dating with accelerated aging dating according to accepted procedures. We plan to extend the  expiration dating when the device is initially released to market. Can the extended expiration dating be based on accelerated aging data or is it required to be real time data? If medical device expiry dating extension is to be based on real time data,where is that stated in the regulations.