FDA's stakeholder meeting on the 510(k)-changes issue offered a range of views, but the agency's representatives indicated their interest in the issue has not waned despite pushback from Capitol Hill last year. FDA's Michael Ryan, a regulatory advisor, said the current regulatory regime "is a little open to interpretation" as to what sort of changes might trigger a new 510(k) filing, and indicated the agency will press the matter with Congress by remarking that some of the changes FDA would make to a 1997 guidance could require new legislation.

The Supreme Court returned its verdict in the Myriad gene patenting case, declaring in a 9-0 decision that isolated DNA is not patentable, but that complementary DNA (cDNA) is, a verdict that left Myriad Genetics (Salt Lake City, Utah) with a bump on Wall Street. The decision closes months of intense anticipation on the parts of the diagnostics and biotechnology industries, which were trying to anticipate how the outcome might affect their futures. Myriad's share prices at Nasdaq rose almost 10% upon the announcement, making clear that investors are happy with the outcome.

We all know there’s no such thing as a free lunch, but what’s not always clear is the cost. The U.S. federal government in two of its incarnations recently put those in the life science industries on alert that the cost of doing business might go up to a degree that may surprise anyone who hasn’t been paying attention. FDA proposed recently to make freely available “de-identified and masked data derived from medical product applications,” citing as a “national priority” the need to improve “the efficiency and effectiveness of...

There’s an old story about a farmer who lost a horse, and the neighbor said “such bad news.” Then the horse came back with a bunch more in tow, and the neighbor said “such good news!” Then the farmer’s son broke his arm breaking one of the new horses and … well you get the idea. Sometimes you can tell the difference, sometimes not. With that in mind, we examine two stories appearing recently in the pages of Medical Device Daily. CMS; Trustees report is happy, happy The Centers for...