Skadden: An Exercise in Moderation: FDA's 510(k) Plan is Notable Mostly for What it Does Not Include | Practical Law
This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the Center for Devices and Radiological Health's (CDRH) Plan of Action regarding the 510(k) process, which commits to 25 action items during 2011, including three proposed regulations, seven new guidance documents and other administrative and regulatory initiatives.