Design Con 2015
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.



Most Recent Comments
David Ashton
 
prabhakar_deosthali
 
Crusty1
 
Rama Murthy
 
David Ashton
 
GeoffBoyd
 
moronda
 
seaEE
 
Joe.Sleator
Top Comments of the Week
Flash Poll
Like Us on Facebook

Datasheets.com Parts Search

185 million searchable parts
(please enter a part number or hit search to begin)
EE Life
Frankenstein's Fix, Teardowns, Sideshows, Design Contests, Reader Content & More
Max Maxfield

Feast Your Orbs on My Vetinari Clock Prototype
Max Maxfield
13 comments
Well, I have to admit that I have a great big Cheshire Cat-type grin plastered on my face at the moment, because the prototype for my Vetinari Clock project is now well underway.

Jack Ganssle, Embedded.com

Open Office: Your Fart is My Problem
Jack Ganssle, Embedded.com
11 comments
A Washington Post article, Google got it wrong. The open-office trend is destroying the workplace, describes how the author's ad agency moved her from a private office to an open space ...

Rich Quinnell

Bloopers Book Helps Improve GUI Development
Rich Quinnell
2 comments
Courtesy of fellow editor "Max" Maxfield (aka Max the Magnificent), I recently acquired a copy of GUI Bloopers 2.0 by Jeff Johnson of UI Wizards. I found it an interesting read chock full ...

Rich Quinnell

Making the Grade in Industrial Design
Rich Quinnell
16 comments
As every developer knows, there are the paper specifications for a product design, and then there are the real requirements. The paper specs are dry, bland, and rigidly numeric, making ...

Special Video Section
The LT8640 is a 42V, 5A synchronous step-down regulator ...
The LTC2000 high-speed DAC has low noise and excellent ...
How do you protect the load and ensure output continues to ...
General-purpose DACs have applications in instrumentation, ...
Linear Technology demonstrates its latest measurement ...
10:29
Demos from Maxim Integrated at Electronica 2014 show ...
Bosch CEO Stefan Finkbeiner shows off latest combo and ...
STMicroelectronics demoed this simple gesture control ...
Keysight shows you what signals lurk in real-time at 510MHz ...
TE Connectivity's clear-plastic, full-size model car shows ...
Why culture makes Linear Tech a winner.
Recently formed Architects of Modern Power consortium ...
Specially modified Corvette C7 Stingray responds to ex Indy ...
Avago’s ACPL-K30T is the first solid-state driver qualified ...
NXP launches its line of multi-gate, multifunction, ...
Doug Bailey, VP of marketing at Power Integrations, gives a ...
See how to ease software bring-up with DesignWare IP ...
DesignWare IP Prototyping Kits enable fast software ...
This video explores the LT3086, a new member of our LDO+ ...
In today’s modern electronic systems, the need for power ...