“FDA Commissioner Scott Gottlieb says he’s rolling out a new approach aimed at modernizing the agency’s 510(k) clearance system—the abbreviated pathway it uses to approve the bulk of medical devices that resemble existing products. In a “Sunday tweetorial,” Gottlieb said…” Read the full article here.
Source: FDA READY TO MOVE ON 510(k) – By Arthur Allen, November 26, 2018. POLITICO.
