The AffiliateMarketIngtools of Sciences, Engineering and Medicine
Office of Congressional and government Affairs
At A Glance
 
 
Briefing
: Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35
Dates:
Thu, Jul 28, 2011   305 Hart Senate Office Bldg. -- 11:00 a.m.
Fri, Jul 8, 2011   309 Hart Senate Office Bldg. - 12:00 p.m.
Fri, Jul 8, 2011   430 Dirksen Senate Office Bldg. - 2:00 p.m.
Fri, Jul 8, 2011   G31 Dirksen Senate Office Bldg. - 3:00 p.m.
Fri, Jul 8, 2011   2321 Rayburn House Office Bldg. - 4:30 p.m.
Mon, Aug 1, 2011   430 Dirksen Senate Office Bldg. 10:00 a.m.

 

THE NATIONAL ACADEMIES
Institute of Medicine
Board on Population Health and Public Health Practice
Committee on the Public Health Effectiveness of the FDA 510 (k) Clearance Process

*****

Congressional Briefings

on

Medical Devices and the Public's Health:
The FDA 510(k) Clearance Process at 35 Years

At the request of the Food and Drug Administration, the Institute of Medicine examined the 510(k) clearance process, which requires device manufacturers to demonstrate that their new product is substantially equivalent to an already approved device. This report looks at that process, evaluating whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process.

These series of briefings were for members of Congress and congressional staff only. The report was publicly released on July 28, 2011 and can be found, in its entirety, on the .

 


 

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