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

Creating a Vetinari Clock Using Antique Analog Meters
Max Maxfield
25 comments
As you may recall, the Mighty Hamster (a.k.a. Mike Field) graced my humble office with a visit a couple of weeks ago. (See All Hail the Mighty Hamster.) While he was here, Hamster noticed ...

EDN Staff

11 Summer Vacation Spots for Engineers
EDN Staff
11 comments
This collection of places from technology history, museums, and modern marvels is a roadmap for an engineering adventure that will take you around the world. Here are just a few spots ...

Glen Chenier

Engineers Solve Analog/Digital Problem, Invent Creative Expletives
Glen Chenier
11 comments
- An analog engineer and a digital engineer join forces, use their respective skills, and pull a few bunnies out of a hat to troubleshoot a system with which they are completely ...

Larry Desjardin

Engineers Should Study Finance: 5 Reasons Why
Larry Desjardin
45 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 ...

Flash Poll
Top Comments of the Week
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)