On February 15, 2011, the Federal Food and Drug Administration (FDA) published a final rule that defines Medical Device Data Systems (MDDSs) and establishes the regulatory requirements applicable to MDDSs. Historically there has been confusion about the regulatory status of these products (and certain other kinds of software); FDA’s rule clarifies the agency’s view of this subset of computer products.

The final rule makes clear that FDA considers MDDSs to be medical devices and expects manufacturers of these products (including, in certain circumstances, health care institutions or providers) to comply with certain requirements applicable to medical devices, including requirements for medical device listing and establishment registration, adverse event reporting (Medical Device Reporting), and current good manufacturing practices, including design development requirements—but not including premarket review or clearance requirements (i.e., 510(k) clearance). Products falling within FDA’s definition of MDDSs, and parties required to comply with the MDDS requirements announced in the rule, are described below.

Please see full Alert below for further information.