Medical device

Definition and stakes

United States. Congress,  America’s Affordable Health Choices Act of 2009…

“ The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that— `` (A) is or has been used in or on a patient; and `` (B) is— `` (i) a class III device; or `` (ii) a class II device that is implantable, life-supporting, or life-sustaining. ”
Source: Wikisource

Portrait of George W. Bush George W. Bush,  Presidential Radio Address (2002)

“ Medical devices are often very complex and require careful testing before they're approved by the Food and Drug Administration. But the FDA is overwhelmed by the volume of new technologies, making delays more frequent, and undermining the quality of device reviews. ”
Source: Wikisource

Portrait of Anthony Kennedy Anthony Kennedy,  Eli Lilly and Company v. Medtronic Inc…

“ Congress did not act in an irrational manner when it drew a distinction between drugs and medical devices. True, like medical devices, some drugs have a very high cost. See ante, at 673, n. 5. Testing a patented medical device, however, often will have greater effects on the patent holder's rights than comparable testing of a patented drug. As petitioner has asserted, manufacturers may test generic versions of patented drugs, but not devices, under abbreviated procedures. ”
Source: Wikisource

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