FDA in 2018 - Obstructing and Over-regulating 510(k)

robert.beck

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Has anyone else found the 510(k) process more difficult now than in the past? I recently submitted a 510(k) for a very low risk device, and got 17 major deficiencies and 1 minor deficiency. Some of them are incredibly picky and several do not have any regulatory or guidance document basis. Further, the reviewer was slightly sarcastic, and has not responded to an email. The deficiency letter gave us 10 days to request a teleconference then went on state limitations about what could be asked during the teleconference, and strongly suggested using the Q-sub process. The Q-sub process involves more paperwork and bureaucracy.

It's going to take a lot of work to respond to some of these 'deficiencies.' One in particular is plainly ridiculous. I am wondering if there is some internal turf battle within FDA that is driving this change.
 

DEVigil

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Actually, my experience was the polar opposite. I submitted a 510(k) for a new device of moderate concern, and received approval less than 30 days later with no communication in between (other than the usual milestones of acceptance, reviewer assignment, etc.). No one was more shocked than I was. Perhaps our device went to a different review panel.

Not all deficiencies relate back to a regulatory or guidance document directly, which the agency's guidance document on deficiencies takes into account. However, if the reviewer is claiming deficiencies based on regulations/guidelines, he's supposed to include a reference to them. Personally, I'd push back on those to get at least that much clarification. In theory, his letter had supervisory approval before it was sent, so if it's as bad as you say it seems like that might have been little more than a rubber stamp process :(.

I'm sorry you're going through this experience, it sounds very aggravating and stressful.
 

robert.beck

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when did you get your approval? i have a colleague who sent in a 510(k) for an updated version of a previously approved device, and got a worse letter back than I did. That company took it to a lawyer, and now they are going through the Q-sub process for several responses. For obvious reasons, I don't have much detail, but that letter has 22 deficiencies. So it's just not an isolated case.
 

DEVigil

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We submitted March 6, 2018, and were approved April 4, 2018.


Wow. I really do wonder if it's a different classification panel. Ours went to RA.
 

Mark Meer

Trusted Information Resource
Has anyone else found the 510(k) process more difficult now than in the past?...

I've had both experiences: difficult, drawn out process, and approval without issue, and I'd say there are two uncontrollable variables:
1. Reviewer's disposition
2. State of the art, level of concern

The first, unfortunately, there is nothing you can do about. Luck of the draw. I also have had an obsessive reviewer with a bad temperament that nit-picked and was generally difficult to deal with. Our policy was to "just do as they say", so in this case we did the leg work to respond to all deficiencies at great expense and a slightly over-engineered product. To the extent that FDA employees are more likely to have this disposition (may or may not be the case) then yes, I guess you could say the probability of the process being more difficult has increased.

The second variable you can, to a certain degree, anticipate and prepare for. For example, back a few years, safety of lithium batteries became a big concern, and we hence made sure that our battery-safety documentation was very (overly?) robust. Nowadays, I'd guess that software might be something reviewers may be likely/instructed to fixate on.

I definitely share your frustration that the difficultly of the process does appear to be quite variable.
 

robert.beck

Involved In Discussions
thanks for you information. when did these good and bad experiences happen? and what was the panel? i am trying to understand whether FDA is different under current commissioner, or if the variability is due to specific device types/panels?
 

Mark Meer

Trusted Information Resource
I've only been through two so far: one (the more difficult) was back in 2013, the other (smoother) was 2016.
Both were Physical Medicine panel, both were Class II, both shared same ProCode & regulation. We used the same format as per guidance, and provided essentially the same documents/report/standards (differences between the two products and updated standards, notwithstanding).

Granted, this is only an n of 2...hardly enough to make any definitive conclusions.
But the similarity of the two applications yet very different experiences, combined with testimonials from others 510(k) applicants, leads me to suspect that experiences can indeed vary, and the variance is often due to some combination of the two factors I mentioned.
 

robert.beck

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I've done about 15-20 for various companies as a consultant. Many of them had significantly higher risk profiles and were more complex than the one I'm now struggling with. This is the first time I've gotten requests for additional information that are not sane.
 

Sidney Vianna

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Leader
Admin
I am wondering if there is some internal turf battle within FDA that is driving this change.
For outsiders, it is impossible to know exactly the reason behind the perceived overly strict review. It is possible that different reviewers set different level of expectations. Consistency is not always possible, when we are dealing with people and their intrinsic differences.

I have no experience dealing with the FDA, but I would hope that submitters of 510k packages would have some escalation recourse if and when they are dealing with unreasonable reviewers. I would pursue that avenue if I really believe that the review is being unfairly performed.
 
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