Regulatory Open Forum

This is just a heads up that I've been working on a summary of the comments that were posted to regulations.gov regarding FDA's proposal to publish a list of 510(k) devices with predicates that are more than 10 years old.

I'll be posting the summary here in the forum for those who are interested in this topic.  There were a lot of comments about multiple aspects of the proposal, so I will be breaking the summary across multiple posts, ideally at a pace of 2-3 a week for a couple of weeks, but we'll see how my schedule goes.

In reviewing the comments, I have been surprised by 1) the diversity of the perspectives represented, 2) the strong consensus among the commenters, given the diversity of perspectives, and 3) the time, considered thought, and effort that many commenters clearly put into their responses.

Personally, I was also surprised at how many of my own comments about the proposal were echoed by others.  I've never considered myself to be any kind of bellwether for the industry, and maybe more like the opposite.  But perhaps I've been swimming in the wrong tidepools.

This is just a heads up that I've been working on a summary of the comments that were posted to regulations.gov regarding FDA's proposal to publish a list of 510(k) devices with predicates that are more than 10 years old.

I'll be posting the summary here in the forum for those who are interested in this topic.  There were a lot of comments about multiple aspects of the proposal, so I will be breaking the summary across multiple posts, ideally at a pace of 2-3 a week for a couple of weeks, but we'll see how my schedule goes.

In reviewing the comments, I have been surprised by 1) the diversity of the perspectives represented, 2) the strong consensus among the commenters, given the diversity of perspectives, and 3) the time, considered thought, and effort that many commenters clearly put into their responses.

Personally, I was also surprised at how many of my own comments about the proposal were echoed by others.  I've never considered myself to be any kind of bellwether for the industry, and maybe more like the opposite.  But perhaps I've been swimming in the wrong tidepools.

This is just a heads up that I've been working on a summary of the comments that were posted to regulations.gov regarding FDA's proposal to publish a list of 510(k) devices with predicates that are more than 10 years old.

I'll be posting the summary here in the forum for those who are interested in this topic.  There were a lot of comments about multiple aspects of the proposal, so I will be breaking the summary across multiple posts, ideally at a pace of 2-3 a week for a couple of weeks, but we'll see how my schedule goes.

In reviewing the comments, I have been surprised by 1) the diversity of the perspectives represented, 2) the strong consensus among the commenters, given the diversity of perspectives, and 3) the time, considered thought, and effort that many commenters clearly put into their responses.

Personally, I was also surprised at how many of my own comments about the proposal were echoed by others.  I've never considered myself to be any kind of bellwether for the industry, and maybe more like the opposite.  But perhaps I've been swimming in the wrong tidepools.

This is just a heads up that I've been working on a summary of the comments that were posted to regulations.gov regarding FDA's proposal to publish a list of 510(k) devices with predicates that are more than 10 years old.

I'll be posting the summary here in the forum for those who are interested in this topic.  There were a lot of comments about multiple aspects of the proposal, so I will be breaking the summary across multiple posts, ideally at a pace of 2-3 a week for a couple of weeks, but we'll see how my schedule goes.

In reviewing the comments, I have been surprised by 1) the diversity of the perspectives represented, 2) the strong consensus among the commenters, given the diversity of perspectives, and 3) the time, considered thought, and effort that many commenters clearly put into their responses.

Personally, I was also surprised at how many of my own comments about the proposal were echoed by others.  I've never considered myself to be any kind of bellwether for the industry, and maybe more like the opposite.  But perhaps I've been swimming in the wrong tidepools.