Julie Omohundro In the article, you are quoted as saying that FDA's updated model for the pre-cert program violates the current 510(k) regulation. Could you expand on this?

Stephen Allan Weitzman Absolutely correct. The program can only be implemented with new legislation.

Bradley Merrill Thompson, RAC Julie, it's a bit complex for a brief comment, but at a high level, the 510(k) requirement is a binding legal requirement. So any new program such as the precert program would need to either meet the terms of that legal requirement, or meet the terms of a specific exemption from that legal requirement. The precert program does neither. I will be expanding on this in the coming days in a separate article.

Julie Omohundro So, in essence, FDA doesn't have the legal authority to override the requirement to demonstrate substantial equivalence?

Julie Omohundro PS I'm leaning toward the idea that Congress might do well to establish a separate center for standalone medical software products, as they did for tobacco products. What do you think?

Bradley Merrill Thompson, RAC Correct, at least without rulemaking and perhaps without statutory authority. There is a regulation on the books that FDA can't simply just ignore.

Julie Omohundro I'm not sure about the latter. What's to prevent FDA from ignoring it? If they ignore it, then I think someone would have to pursue this in court? And who would have the motivation to do that? My impression is that the software industry would prefer pre-cert.

Bradley Merrill Thompson, RAC There are always unhappy parties with any major change. Consider patient groups, provider groups, insurers and others.

Julie Omohundro Agreed, but I'm wondering which, if any, of these unhappy parties might be likely to pursue the matter in court?

Patient groups will sometimes go to court, but they tend to coalesce around a particular disease, condition, or device, rather than this type of broader regulatory issue.

If providers and insurers decide they don't trust products coming through FDA via pre-cert instead of 510(k), I wouldn't think they'd go to court. I think they would just not buy/cover them.

Gran información