Embedded Systems Conference
Breaking News
Comments
Newest First | Oldest First | Threaded View
Warren3
User Rank
Author
re: FDA to change 510(k) process 25 ways
Warren3   1/20/2011 5:33:51 PM
NO RATINGS
The response I'm seeing on the web is well described by another's wrap-up as the industry being "cautiously optimistic". There are a lot of changes under review and there is some dissappointment that only a small portion of which is covered by these recent proposed changes. But, again, the indications are positive. On a different note, I found it interesting that in the Medtronic "complaint" piece on 1/11/2011 it is the CEO expressing his concerns, while in this article the "FDA improvements look promising" Medtronic statement is supplied by their chief regulatory officer. For now I'm choosing to consider this as Medtronic's way of saying "we're seeing changes that make us feel optimistic but there's much more that should be done."

rick merritt
User Rank
Author
re: FDA to change 510(k) process 25 ways
rick merritt   1/20/2011 3:24:29 PM
NO RATINGS
@Selinz: The FDA has long had two parallel paths--PMA for new devices and 510(k) for devices similar to approved ones. Yes, PMA is longer and more rigorous. The goal is safety, but it no doubt impacts speed of innovation, too.

selinz
User Rank
Author
re: FDA to change 510(k) process 25 ways
selinz   1/20/2011 1:17:21 AM
NO RATINGS
Well, if I'm interpreting this correctly, similar devices by presumably other companies require less qualification. DOesn't this mean the first company that creates a new technology will bear the burden of all of the initial qualification? Subsequent companies can make similar devices and not have to go through the same level of qualificaiton? It seems that could have the effect of stifling new, innovative products...



Radio
LATEST ARCHIVED BROADCAST
As data rates begin to move beyond 25 Gbps channels, new problems arise. Getting to 50 Gbps channels might not be possible with the traditional NRZ (2-level) signaling. PAM4 lets data rates double with only a small increase in channel bandwidth by sending two bits per symbol. But, it brings new measurement and analysis problems. Signal integrity sage Ransom Stephens will explain how PAM4 differs from NRZ and what to expect in design, measurement, and signal analysis.

Datasheets.com Parts Search

185 million searchable parts
(please enter a part number or hit search to begin)
Like Us on Facebook
Special Video Section
The LTC®6363 is a low power, low noise, fully differential ...
Vincent Ching, applications engineer at Avago Technologies, ...
The LT®6375 is a unity-gain difference amplifier which ...
The LTC®4015 is a complete synchronous buck controller/ ...
10:35
The LTC®2983 measures a wide variety of temperature sensors ...
The LTC®3886 is a dual PolyPhase DC/DC synchronous ...
The LTC®2348-18 is an 18-bit, low noise 8-channel ...
The LT®3042 is a high performance low dropout linear ...
Chwan-Jye Foo (C.J Foo), product marketing manager for ...
The LT®3752/LT3752-1 are current mode PWM controllers ...
LED lighting is an important feature in today’s and future ...
Active balancing of series connected battery stacks exists ...
After a four-year absence, Infineon returns to Mobile World ...
A laptop’s 65-watt adapter can be made 6 times smaller and ...
An industry network should have device and data security at ...
The LTC2975 is a four-channel PMBus Power System Manager ...
In this video, a new high speed CMOS output comparator ...
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 ...