How Do You Feel About FDA 510(k) Refuse to Accept?

Have you had any experiences regarding the new(er) FDA approach for reviewing 510(k) submissions? The approach I’m referring to is the “refuse to accept” or RTA checklist. In a nutshell, once a 510(k) submission is received by FDA, there is an initial RTA review conducted to ensure that all elements of the 510(k) have been provided. This initial review happens within 15 days of receipt, and the sponsor is notified that their submission has either been accepted or refused. If accepted, the 510(k) goes to the next reviewer who will dig into the substance. If refused, a RTA checklist is provided to the sponsor, indicating where the submission shortcomings are.

Pretty sweet, right? Quick feedback from FDA on your 510(k). Yeah, not so fast.

The RTA feedback is provided pretty quickly. However, this review is described as a more administrative type of review. And based on my own experience and some anecdotes provided by colleagues, FDA seems to be seeking reasons to refuse 510(k)s and push them back to the sponsor to correct or update. I can tell you from my own experience, it definitely seems as though there is some nitpicking going on. I’ll elaborate.

In early July, I submitted a 510(k) for a fairly simple and straight forward disposable, single use device. The predicate was a very good match. Of course I followed FDA guidance documents, checklists, etc. for what to put into a 510(k). I also reviewed the RTA checklist as I compiled the 510(k) documents. Of course I felt the submission was complete. Why would I send it to FDA if otherwise? A couple weeks after submitting, I received a “refuse” response from FDA. The response included the RTA checklist with reviewer comments. I reviewed and obviously had a difference of opinion. I scheduled a call with the reviewer, where we walked through each concern one by one. I discussed an action plan for each and got buy in from the reviewer. She even confirmed the buy via email. It took us a few weeks, but we were able to address the shortcomings and reviewer comments.

In early August, the RTA response was submitted. A couple weeks later, I received a phone call from a FDA reviewer–someone different than the person who first reviewed the submission. He had a few questions, I had a few of my own. He said he would get back with me and did so the next day, this time with a few more questions. I was kind of confused at this point. Some of the things he asked about was marked as fine by the first reviewer. Other points of discussion pertained to how we addressed the issues identified by the first reviewer. Keep in mind, we discussed the specific action plan with the first reviewer who agreed with our plan. Any way, the second reviewer said he needed to discuss the issues with the branch chief and would get back with me.

He did later that day by sending another “refuse” response and the RTA checklist. I reviewed his remarks and was kind of baffled. He marked a couple things as unacceptable that were non-issues for the first reviewer. And the he was not satisfied with the objective evidence provided to address reviewer one’s concerns. I requested a phone call to discuss each item, which he obliged. During the call, I asked why FDA had changed their response from acceptable to unacceptable on some of the items and why the evidence provided to address the first reviewer’s concerns was determined insufficient. The reviewer told me I should just disregard the first reviewer’s comments, indicating they did not count and that he started the review over from the beginning.

Really? The first review didn’t count. We’re starting over? Sorry, but WTF! Do you think I can just say to the startup “. . . ¬†Well, we the last month didn’t really count. Our project is delayed and we are no closer to getting to market. It’s no big deal though. We’re starting the review over from scratch.” And then I wonder if this is how it’s going to be when I send my next RTA response to FDA.

I decided to do something about it. I contacted the branch chief and FDA ombudsman. The concern I expressed is the inconsistency in responses and direction from one reviewer to the next. I’m waiting on a response and will let you know what I learn. The decision to send a message to the branch chief was a little difficult. I already have one submission with FDA. Two others are planned soon. But at the same time, just rolling over and taking it didn’t seem like an option either. It helped to learn that a few colleagues are also dealing with similar issues.

Let’s just say it seems as though FDA is still learning how to apply the RTA process. And it’s definitely clear the opinions vary from reviewer to reviewer. It also seems as though there is a decent about of review on the actual substance happening in this phase. I know it’s the FDA way these day, no matter how frustrating.

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