Pulse Check: FDA Provides Clarification on the "Add-to-File" Process
Michelle's Moment: For those of you who follow my newsletters, blogs, and webinars, you will be familiar with my commentary on FDA's recent final guidance Safety Considerations to Mitigate the Risk of Misconnection with Small-bore Connectors Intended for Enteral Applications. This guidance recommended industry use an "add-to-file" pathway to submit design changes needed to comply with the new connector standards. I don't know about you, but this was the first I had heard of an "add-to-file". I went on a mission to find out more about what the FDA expects this process to look like.
Allow me to briefly recap my communication chains:
I initially sough clarification from DICE on this new way o fusing add-to-file. DICE told me that add-to-file did not exist on the device side and was a tool on the drug side only. The DICE personnel were not aware of the new requirement in the guidance. I was passed to the Gastroenterology division, where the guidance originated, for further assistance. The division provided a very lengthy but contradictory response. In the response, the FDA recommended an add-to-file contain among other things, identification of deviations from and adaptations to the standard. However, the next section of FDA's response contradicted itself by asserting "Deviations from, or adaptions to, the standard are not anticipated... if devices are found to not be in full conformity with the standard, a 510(k) may be requested".
Needless to say, the response answers some questions, but begs others.
Last month I attended MedCon, which the FDA attended in force. Again, "add-to-file" was casually mentioned by a presenter as "a good way to keep FDA updated on design changes not requiring a submission". I had an opportunity to ask my questions about add-to-file directly to the director of the Premarket Notification [510(k)] Program who was a panelist taking questions. At the time, the FDA was still stumped about how to explain what an add-to-file was, the proper contents given the new guidance requirements, and boundaries between an add-to-file and letter to file. The director took an action item to follow up after the conference to provide an answer.
For the full dialogue that ensued with the FDA download the May Pule Check! I highly recommend it as an entertaining read!
After several back and forth exchanges, the FDA responded as follows:
I do agree with what you are stating and it seems we have an issue here. Believe it or not the division using the non-existent [their words, not mine] add to file program was actually an attempt at the way around not having the industry submit thousands of 510(k)s for companies to comply with the connector issue. We believed that this would be a one-off solution that would be beneficial to the industry and FDA. We still have the same concerns with add to files because of the whole change of ownership issue and the FDA not updating the database. I guess my answer should have been we do not want add to files unless we specifically ask for one.
For what it is worth, that reflects that FDA's current thinking, and lack thereof, on the add-to-file process. Be sure to download May's Pulse Check for the answers to more questions on the add-to-file process. In summary, it seems the FDA could have just said, "we don't want them except when we do. Which we really don't. But we kinda do". It would have offered just as much insight.
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