If you’ll indulge a little humblebragging, this is something for my career scrapbook.
leanRAQA led a successful initiative to overturn an FDA rule to down-classify nearly 90 devices to either Class 1 or Class 2 and make them 510(k) exempt.
I shared the story, transcript below, with Medical Devices Group Chairman Joe Hage.
Joe Hage: Tell me about Docket No. FDA-2021-Z-0025. You shared this the other day and what are we looking at?
Michelle Lott: This is FDA’s final response to a rule published mid-January that proposed to down-classify nearly 90 devices to either Class 1 or Class 2 and make them 510(k) exempt.
Download the spreadsheet for reference.
I was really passionate about this project: I took every single one of these devices and analyzed it against the FDA databases. I made this giant spreadsheet and posted on LinkedIn.
I encouraged people to read, educate themselves, and comment. 39 people commented on the rule between January and March, when the comment period closed – and of the 39 comments, 30 were from my campaign on LinkedIn.
It was just a example of getting to have a voice and your voice getting heard because the Federal Register withdrew the proposed rule and made it null and void.
Not only did they do that – they could’ve done that fairly quietly – but they did it with one of the most scathing and critical withdrawals I’ve ever seen.
Some of my favorite comments were,
- “We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the notice.”
- “The notice was published without adequate scientific support.”
- “The notice contained errors and ambiguities.”
- “The notice is otherwise flawed.”
- “HHS has received dozens of inquiries about the January 15th notice.”
THAT WAS US! We were the dozens of inquiries to HHS!
Then it calls us out in at least three or four places:
- “For example, there were many comments…. “
- “… as noted in several comments…”
- “… as some comments noted…”
- and then it concluded with, “These errors and ambiguities make it difficult or impossible in some circumstances to discern which Class 2 device, the notice is even proposing to exempt(!), as noted by some commentators.”
“For these reasons, HHS and FDA are withdrawing the proposed exemption.”
Joe Hage: Oh wow. That’s pretty damn big.
Michelle Lott: I’m very proud of this. This is going to go in my career scrapbook for sure.
Joe Hage: So each of the devices on that terrific list are staying right where they were?
Michelle Lott: And the seven that were already Class 1 that required a 510(k), they’re pulling those out and analyzing them on a separate bill.
Joe Hage: That’s fantastic. For clarity, what exactly did you help stop from happening?
Michelle Lott: There were several moderate-to-fairly high-risk devices they were proposing to remove from most of FDA-direct oversight, making them 510(k) exempt where FDA didn’t have to review their performance data, including catheters that go in the interstitial space between your brain and your skull!
I would want FDA to verify the performance and safety and sterility and biocompatibility data of anything going to go next to my brain!
My favorite: Anti-microbial surgical masks that require currently about $500,000 worth of testing to demonstrate they are safe and effective were on the list, plus a lot of cancer-diagnosis devices.
It was nonsensical. The devices they were proposing.
They did it just by doing a MAUDE database search to see if the devices had killed anybody. They didn’t look in the databases to see if they’d hurt anybody.
And one of the devices that hadn’t killed anybody hurt 72 people.
Joe Hage: That’s just a fantastic story. Thank you so much on behalf of the industry.
