"Catchup" 510(k)s

This issue was posed by an attendee at my recent webinar on Device Changes and the 510(k),
discussing FDA's K97-1 and their two new August 8, 2016 draft guidance documents.

We have several older devices that were cleared in the late 90's. These have gone through several changes over the years that were all justified as being not significant, so no new 510(k)'s were filed. We have heard about companies in our industry doing what they would consider "catchup" 510(k)'s where they are essentially submitting a 510(k) every so often since the creep effect tends to happen even if they do not see all of the changes as necessarily justifying a new 510(k) per the regs. We would like to do this with some of our products. My questions are 1. Have you ever seen/heard of this approach and would you recommend it and 2. If we did this, obviously it would be for all of the changes that have already taken place on the device so how would that affect the marketing of your device during the review? I know you mentioned that if you had a change and decided to submit a new 510(k) you would obviously have to wait on the FDA's approval before enacting that change, but all of our changes have already been enacted. Would you need to wait until your next change/come up with a small change to submit a new 510(k)?

My responses:

QUES 1. Have you ever seen/heard of this approach and would you recommend it?

ANS:  Tho I've heard of it occasionally I don't recommend it.  I view it as a waste of the company's money and the FDA's time.  

I've repeatedly seen FDA Investigators have no problems with routine changes to devices having the last 510(k) dated from the early 1990's, subject to the following caveats:  

IF the principles of design control are used for the changes (820.30)(remember design control came on in 1996-7, so while a DHF and the other 8 elements weren't a requirement before the mid-90's, they would  be for the changed device after); 

AND/OR CGMP document / production process change control is rigorous (820.40 and 820.70), well documented; 

AND fully supported by patient risk management (ISO 14971), usability (human factors) engineering (IEC 62366-1, -2); 

AND applicable verifications (tests) and validations (sum total of tests for a device/process/equipment), as appropriate, fully / scientifically support the decision; 

AND the points in the webinar per K97-1 (and the drafts) are followed / documented;

AND all the above lead to an honest decision that each change, And the cummulative changes, DO NOT raise new issues of safety / effectiveness (or the mandatory issues for a new 510(k) like Indications for Use, Performance ... aren't applicable...).  

"Catchup" is not an FDA term or requirement per se.  It is only applicable if one of the two points emphasized in the FDA memo / guidances and the webinar apply:  

1) the last change is major enough to raise new issues of safety /  effectiveness; or 

2) all the cummulative minor changes, with the last one being the "tipping point" considered together, now raise new issues of safety / effectiveness. 

The K97-1 and the two drafts emphasize that it is the company's responsibility to make the decision re: need for a new 510(k), and that most device changes handled under the QS Regulation (21 CFR 820) will not require a new 510(k).

To do "catchup" just to play it safe to me is a cop out (trying to push the company's responsibility to make that decision into the FDA's lap) against the above disciplines that have to be in force at a company anyway for it to be CGMP compliant.  My opinion. 

QUES 2. If we did this, obviously it would be for all of the changes that have already taken place on the device so how would that affect the marketing of your device during the review? I know you mentioned that if you had a change and decided to submit a new 510(k) you would obviously have to wait on the FDA’s approval before enacting that change, but all of our changes have already been enacted. Would you need to wait until your next change/come up with a small change to submit a new 510(k)?

ANS:  My answer to the above is the same as my discussion on the slide about a "wrong" decision, tho in this case it is the company, not the FDA, that thinks the company should have filed a new 510(k) for an earlier change. 

Again, the issue is if the last change(s) raised new issues of safety and efficacy that cannot be fully settled by test (V&V) data, or are expressesly called for in the K97-1 / guidances (as mentioned in 1 above), then a new 510(k) is required.

If a new 510(k) is required for safety / efficacy issues, or the other reasons mentioned in K97-1 / draft guidances (not just a general "catchup"), then the version(s) having the new safety / efficacy issues cannot be marketed until cleared (by a cleared 510(k)) by the FDA. 

The version of the device having those previous changes up to the point where those new issues are raised can continue to be marketed / sold.

If the decision to file a new 510(k) is based on new safety / efficacy issues (not just "catchup"), you would file at the point of that finding, e.g., due to an internal audit, FDA audit, etc., and not wait to have another change before filing.

Any time a new 510(k) is filled, all changes to the device, from  the last cleared company 510(k) to the time of filing the new would be included in the new submission.

Once the new 510(k) is cleared by the FDA, the cycle above (and as discussed by the webinar and in the guidances) starts over, with the new, cleared 510(k) as your new device "baseline".

[note:  K 97-1 and the two draft guidance documents on device / software changes have been replaced by two new guidance documents (on devices, and on software in devices or as a device) on evaluating changes as to need to file a new 510(k)]

John E. Lincoln    jel@jelincoln.com

Updated: 06/20/2022