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As I said repeatedly, I'm reading the law as it is written, agreeing strongly with the dissenting judge's opinion in this case. I work in medical device manufac
by jjk166 5y ago
As I said repeatedly, I'm reading the law as it is written, agreeing strongly with the dissenting judge's opinion in this case. I work in medical device manufacturing, and everyone I know in the field considers devices to be usage specific - that's how they're designed and that's how they're regulated. The FDA has only ever banned 3 devices, and all of them have been banned only for specific use cases.
You seem to be mistaking the argument as saying the FDA has authority to regulate the practice of medicine. No one is saying that. I am saying that the FDA has the authority to ban a device, and that the device's use is a part of it, a point you say you agree with.
At issue here is the definition of legally marketed device. If you hold that an ESD for smoking is the same device as an ESD for self injury, then the legal availability of the former means that the latter is also legally available, and thus physicians may use it. However, my argument, which is also the FDA's argument, is that these are clearly two separate devices. They're not buying an ESD for smoking and using it off-label to treat self injury, they are making a custom device with a different control scheme to do a different task.
If these are two distinct devices, the FDA unambiguously has the authority to ban one of them. And if it is banned, it is not a legally marketed device available for off-label use.
Both common sense and precedent indicate devices with different intended uses are different devices which ought to be regulated differently. Paraphrasing from the FDA's ban: the reason that this device needed to be banned in the first place instead of just modifying the label is that the source of the risk is the labelled use, not an off-label use that would be covered by the exemption. Off-label use of a different type of ESD device is fine, but on-label use of this type is not.
[1] https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior https://www.federalregister.gov/documents/2020/03/06/2020-04...
- s1artibartfast 5y agoI violently agree with you on the topics of intended use. >You seem to be mistaking the argument as saying the FDA has authority to regulate the practice of medicine. No one is saying that. The majority opinion believed this ban crossed over. If I understood your statements correctly, you also objected to FDA jurisdiction over off-label prescription of Viagra, or off-label use of hammers. apologies if not. >Paraphrasing from the FDA's ban: Off-label use of a different type of ESD device is fine, but on-label use of this type is not This is perhaps the only point where we disagree. The ban seems to cross into the practice of medicine by my reading. Particularly the part that mandates a physician-directed transition plan within 180 days of publication. It also applies to devices already in commercial distribution and devices already sold to the ultimate (end) user. As the court majority points out: "seizing existing devices both “limits” and “interferes” with a physician’s ability to prescribe or administer them." I disagree with the majority opinion to the extent it groups ESDs together as a legally marketed products. However, I sympathize with the majority misunderstanding because ESDs for SIB and AB were classified as substantially equivalent to other 510(k) predicate ESDs for behavior modification purposes per CFR 882.5235 and not subject to pre-market approval. Furthermore, matters are even more complicated in that many of the ESDs subject to ban are not even 510(k) registered! The FDA previously ruled them exempt from 510(k) registration per CFR 807.65(d). 807.65(d) exempts physicians who manufacture or otherwise alter devices solely for use in their practice from 510(k) registration or pre-market approval. [1] CFR 807.65(d) comes straight from the Federal Food, Drug, and Cosmetic Act (see section 21 USC 360(g) [2] [1] https://ecfr.federalregister.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-D/section-807.65 https://ecfr.federalregister.gov/current/title-21/chapter-I/... [2] https://uscode.house.gov/view.xhtml?req=%22solely+for+use+in+the+course+of+their+professional+practice%22&f=treesort&fq=true&num=0&hl=true&edition=prelim&granuleId=USC-prelim-title21-section360 https://uscode.house.gov/view.xhtml?req=%22solely+for+use+in...