This rule proposes to implement provisions of the FD&C Act by requiring firms to electronically submit to FDA the device labels and package inserts of certain home-use medical devices. In particular, all devices regulated by the Center for Devices and Radiological Health (CDRH) as Class II and Class III devices and labeled for use in any environment outside a professional healthcare facility would be covered by this rule. FDA intends to make the labeling of these devices available to the public in a searchable FDA-managed or partner Internet website. Firms would be required to submit the device labeling to FDA, initially in Portable Document Format (PDF) but later in Structured Product Labeling (SPL) format.
Regulatory Impact Analysis
Federal Register: 81 FR 71415, October 17, 2016