FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

Oracle February 2019

Matthew Sprankle, Associate in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in the Delphi Consulting Group (DCG) newsletter, Oracle, titled “FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices.”

Following is an excerpt:

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability… [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.

Related reading:

January 16, 2019 – Health Law Advisor, “FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices,” by Matthew Sprankle.