Final Rule Updates and Clarifies Medical Device Classification



The U.S. Food and Drug Administration (FDA) published a Final Rule to the Federal Register on December 17, 2018. It will update 21 CFR 860: “Medical Device Classification Procedures” and will implement changes required by the 2012 FDA Safety and Innovation Act’s (FDASIA) amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new name of the rule is “Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures”. Preamendment devices are those that were legally marketed before the Medical Device Amendments of 1976 (“The 1976 Amendments”), transitional devices were regulated by the FDA as new drugs before the same Amendment, and postamendment devices are marketed after. FDASIA also authorizes the FDA to require a premarket approval (PMA) application for a preamendment class III device (“call for PMA”).

Major Provisions of the Rule:

  • Currently decided by rulemaking, reclassification of devices and call for PMA will be by administrative order.

  • Defines the process for a call for PMA. The FDA will:

    • publish a proposed order in the Federal Register,

    • hold a device classification panel meeting, and

    • take comments into consideration.

  • A call for PMA must allow the manufacturer to request a change in classification based on new information. This can lead to:

    • finalizing the call for PMA, or

    • closing the call for PMA and starting a reclassification.

  • Clarification of when the FDA may begin the reclassification process for a postamendment or transitional device rather than by manufacturer petition.

  • Updates the process for the FDA to reclassify a postamendment or transitional device to:

    • a proposed reclassification order,

    • optional panel consultation, and

    • a final Federal Register published reclassification order after consideration of comments and any panel recommendations.

  • Reclassification of postamendment devices may include special controls as needed.

  • Removes the requirement for a hearing to reclassify a transitional device.

The proposed rule was initially issued March 25, 2014 with a 90 day comment period and was extended for another 90 days on June 12, 2014. The effective date of the final rule will be March 17, 2019. The rule will decrease financial and regulatory burdens for the FDA and device manufacturers and improve consistency for device reclassification while maintaining assurance of device safety and effectiveness.


- The Clinical Pathways Team

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