FDA’s Spring Regulatory Agenda Flags Rulemaking for Devices

HHS unveiled its spring unified agenda for upcoming proposed and final rulemakings, including the following planned FDA actions for medical devices:

• A final rule on medical device classification procedures, expected in November 2018, requiring FDA to use administrative orders to announce or change the classification of devices instead of taking action by issuing regulation.
• A proposed rule, anticipated in July, to harmonize and modernize quality system regulations for medical devices. The revisions will replace existing requirements with specifications for an international consensus standard for medical device manufacture, ISO 13485:2016.
• A proposed rule on the De Novo classification process, anticipated in July, to establish procedures and criteria for the de novo process while making it more transparent and predictable for manufacturers. The De Novo classification reduces regulatory burdens on manufacturers by giving them a less burdensome application pathway for marketing devices.