FDA will exempt more consumer health devices from pre-market review

The Food and Drug Administration issued a new guidance in August 2014 that exempts still more medical devices, some of them consumer devices, from its regulatory scope.  This means the manufacturers of these devices, some of which are connected to apps, no longer have to go through the FDA’s 510(k) review process before they bring their product to market.

FDA announces intention to comprehensively regulate lab-developed tests

The FDA announced July 31, 2014 that it intends to issue a draft guidance soon that would require moderate- and high-risk diagnostics to obtain 510(k) or premarket approval, regardless of their place of origin, putting an end to a battle to regulate laboratory-developed tests (LDTs) that’s been waged for several years.  The planned draft guidance on the regulatory oversight of LDTs ,had been held up by the White House Office of Management and Budget since 2010.

Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say ‘Yes’

Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events?  In a new research letter published this week in Clinical Pharmacology & Therapeutics, two FDA researchers argue that “Internet search logs” could be substantially useful to the agency’s drug regulatory staff in determining which drugs might have unforeseen adverse events.

A Promising Universal Test for Cancer Targets DNA with UV Light

Every type of cancer is unique depending on which cells are affected, how it spreads, and what causes it to arise in the first place.  That has been the basic understanding that has marked cancer as an overarching concept for a variety of uniquely different diseases and so each cancer required its own diagnostic mechanism and treatment regimen.