Comments on: FDA 2010 Weather Forecast: Tougher Regulatory Scrutiny, More Medical Device Inspections http://blog.assurx.com/2010/01/25/fda-2010-weather-forecast-tougher-regulatory-scrutiny-more-medical-device-inspections/ Compliance, quality and risk: Straight talk for regulated industries Tue, 07 Feb 2012 22:43:09 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: FDA 2011 Regulatory Climate: Cloudy, With a Chance of More Regulation http://blog.assurx.com/2010/01/25/fda-2010-weather-forecast-tougher-regulatory-scrutiny-more-medical-device-inspections/#comment-3349 FDA 2011 Regulatory Climate: Cloudy, With a Chance of More Regulation Tue, 28 Dec 2010 19:07:17 +0000 http://blog.assurx.com/?p=1367#comment-3349 [...] Last year we put on our weather forecaster’s hat and called for greater FDA enforcement of medical devices in 2010. For the most part, I’d argue we got that right. [...] [...] Last year we put on our weather forecaster’s hat and called for greater FDA enforcement of medical devices in 2010. For the most part, I’d argue we got that right. [...]

]]> By: Michael Causey http://blog.assurx.com/2010/01/25/fda-2010-weather-forecast-tougher-regulatory-scrutiny-more-medical-device-inspections/#comment-67 Michael Causey Mon, 25 Jan 2010 20:54:50 +0000 http://blog.assurx.com/?p=1367#comment-67 I agree that these are interesting times for medical device companies, Brad. I can also see it going either way here: an over reaction and a lot of regulation, or perhaps industry comments will temper the FDA's approach. I hope that the FDA remembers that it way over reacted with electronic records in the 1990s. Unintentionally, the agency actually slowed the adoption of such technology with its stringent 21 CFR Part 11 regulation. After a few bumpy years, as you'll recall, the agency stepped back quite a bit and adoption of the technology then increased. Will this be a case of history repeating itself or learning from history? We'll find out, won't we? Thanks for the comment. Michael I agree that these are interesting times for medical device companies, Brad.

I can also see it going either way here: an over reaction and a lot of regulation, or perhaps industry comments will temper the FDA’s approach.

I hope that the FDA remembers that it way over reacted with electronic records in the 1990s. Unintentionally, the agency actually slowed the adoption of such technology with its stringent 21 CFR Part 11 regulation. After a few bumpy years, as you’ll recall, the agency stepped back quite a bit and adoption of the technology then increased.

Will this be a case of history repeating itself or learning from history? We’ll find out, won’t we?

Thanks for the comment. Michael

]]> By: Brad http://blog.assurx.com/2010/01/25/fda-2010-weather-forecast-tougher-regulatory-scrutiny-more-medical-device-inspections/#comment-66 Brad Mon, 25 Jan 2010 19:00:29 +0000 http://blog.assurx.com/?p=1367#comment-66 With all of the increased chatter around a new order in the FDA, it's only a matter of time before the public demands evidence of action. To the FDA this evidence will be in the form of increased enforcement, through 483's, fines, and even consent decrees. Some unlucky company is going to be the new "poster child" for this administration, and it is anyone's guess who ends up in the crosshairs. Here's hoping I'm wrong and that any new rules are applied evenly and rationally to encourage innovation while protecting public health and safety. With all of the increased chatter around a new order in the FDA, it’s only a matter of time before the public demands evidence of action. To the FDA this evidence will be in the form of increased enforcement, through 483′s, fines, and even consent decrees. Some unlucky company is going to be the new “poster child” for this administration, and it is anyone’s guess who ends up in the crosshairs. Here’s hoping I’m wrong and that any new rules are applied evenly and rationally to encourage innovation while protecting public health and safety.

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