Last Friday I had the chance to participate in the FDA-Industry IVD Roundtable Meeting held at FDA’s White Oak Campus in Maryland. It was a great opportunity to hear speakers from CDRH, OIVD and CBER talk about what they are working on and their current thinking regarding policy issues. It was also a chance to hear the concerns of industry representatives at the meeting. Even though they may work for different companies, and have different technologies and products, many share the same concerns about changes in regulation.
During the OIVD update given by Dr. Alberto Gutierrez, it was clear that the new RUO/IUO draft guidance document was the hot topic. One attendee commented that the first feedback they wanted to provide on the guidance was regarding the title “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only”. How could a product be an “IVD” and at the same time “RUO” or “IUO”? While I see their point, the RUO and IUO labeling that the guidance refers to is from 21 CFR 809, In Vitro Diagnostics Products for Human Use. For me, the point of the draft guidance is to address the use of RUO and IUO products which are being promoted and used for in vitro diagnostic testing. So maybe that’s not such a bad title after all.
It sounds like FDA plans to work with RUO manufacturers to help bring them into compliance, much like they did when the ASR Guidance was published in 2007. Dr. Gutierrez commented that FDA has shown willingness to collaborate with RUO manufacturers through their efforts with the array CGH meetings, and in their handling of the direct to consumer genetic test market.
That said, if the new RUO/IUO guidance is applicable to a company’s products and practices, FDA strongly encouraged manufacturers to take advantage of the agency’s current offer to help. Waiting to approach FDA on the issue might result in a letter in the future.
Almost all of the FDA speakers mentioned the Pre-IDE process as a key part of a solid regulatory strategy for companies bringing their products to FDA for clearance or approval. Two key take-home points were:
- The input FDA provides manufacturers through the Pre-IDE process is only as good as the questions asked by the manufacturer. Asking vague questions will not lead to in-depth input from the agency. One speaker recommended including a summary and/or the minutes from Pre-IDE meeting(s) in the 510(k) or PMA submission.
- A presenter from CBER commented that FDA can’t, due to resource constraints, provide in depth review and feedback on responses submitted by the manufacturer when they are “off the clock”. This means if you have received questions from the FDA regarding your submission, and you have either draft responses or questions that you would like addressed before you formally respond, FDA is open to having a phone call or email exchange, but not much else. For more in depth review and feedback from FDA, you need to submit your response formally to FDA through the Document Mail Center, so the submission is officially back “on the clock”.
I was happy to hear that the agency has been extremely busy writing new guidance documents on some hot topics. However, the bad news is they can't predict when they will be published, as that’s not really in their control due to the lengthy public and agency review process that is required.
There was some exciting news that guidance has been drafted and/or is under internal review on Companion Diagnostics and Drug/ Diagnostic Co-development. We were told at the meeting not expect these to be “how-to guides”, but rather were focused on FDA policy and process. FDA noted that they could not really provide a “how-to” guide at this time as they are still encountering new situations that they had not considered previously.
Finally, FDA mentioned that there will be a guidance issued on the regulation of LDT’s but there was no clear sign of when this can be expected.
Even after all my years in the industry I always learn something new at these meetings, and I find the open discussion between FDA and industry refreshing and helpful. Thank you FDA for a great meeting!