Breaking News
Comments
Newest First | Oldest First | Threaded View
przem
User Rank
Manager
re: FDA rules may create "innovation wasteland"
przem   11/12/2010 2:00:22 PM
NO RATINGS
One can't help but note a strange correlation of the number of warning letters with the US election cycle: dramatic decrease in 2001-2 and pickup in 2009. A cynical person might conclude that there was a deregulatory period driven by politics.

Sheetal.Pandey
User Rank
Manager
re: FDA rules may create "innovation wasteland"
Sheetal.Pandey   11/12/2010 3:33:14 AM
NO RATINGS
Looks like more politics than actually trying to make some real difference.It would be interesting to know how much delay these procedural changes have made in time to market a device. And whether these process changes have actually brought in any values.

Code Monkey
User Rank
Rookie
re: FDA rules may create "innovation wasteland"
Code Monkey   11/11/2010 11:42:31 PM
NO RATINGS
The FDA, being a govt agency, naturally ends up greasing the skids for big money medicine so that in a few years the recalls and lawsuits start coming. The days when lawsuits were a sufficient deterent are gone, since they are factored into the cost of doing business. So as much as tighter regulations are despised, they are needed. Although copying Europe outright might be a good idea if they have a better system.

sharps_eng
User Rank
Rookie
re: FDA rules may create "innovation wasteland"
sharps_eng   11/11/2010 10:53:43 PM
NO RATINGS
How else do we balance raw market forces flooding the market with incompatible and unsafe products other than by some kind of legislation? We as consumers need protection, unless you think a 'devil take the hindmost' society represents the pinnacle of civilization? And if we don't apply and enforce standards in medical care, why bother anywhere else?

elctrnx_lyf
User Rank
Manager
re: FDA rules may create "innovation wasteland"
elctrnx_lyf   11/11/2010 6:36:22 PM
NO RATINGS
The regulation of medical devices is already a throttle for the innovation. The propsed changes by FDA will make it much more harder for the medical device manufacturers to get the agency approvals and to deliver the products into the market. The US companies trying to reaach the global market with their products may have to put in lot of effort to design the products when compared to the european counter parts.



EE Life
Frankenstein's Fix, Teardowns, Sideshows, Design Contests, Reader Content & More
Max Maxfield

Fist Bumps & the Zombie Apocalypse
Max Maxfield
38 comments
Are you concerned about the possibility of a Zombie Apocalypse or do you scoff at the thought of such an eventuality? If the latter, would you be surprised to hear that the US military has ...

Rishabh N. Mahajani, High School Senior and Future Engineer

Future Engineers: Don’t 'Trip Up' on Your College Road Trip
Rishabh N. Mahajani, High School Senior and Future Engineer
8 comments
A future engineer shares his impressions of a recent tour of top schools and offers advice on making the most of the time-honored tradition of the college road trip.

Larry Desjardin

Engineers Should Study Finance: 5 Reasons Why
Larry Desjardin
41 comments
I'm a big proponent of engineers learning financial basics. Why? Because engineers are making decisions all the time, in multiple ways. Having a good financial understanding guides these ...

Karen Field

July Cartoon Caption Contest: Let's Talk Some Trash
Karen Field
151 comments
Steve Jobs allegedly got his start by dumpster diving with the Computer Club at Homestead High in the early 1970s.

Top Comments of the Week
Flash Poll
Like Us on Facebook
EE Times on Twitter
EE Times Twitter Feed

Datasheets.com Parts Search

185 million searchable parts
(please enter a part number or hit search to begin)