• FDA Issues Rule to Regulate Medical Device Data Systems
  • March 2, 2011
  • Law Firm: King Spalding LLP - Atlanta Office
  • 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.i 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.