FDA Proposes Improvements in De Novo Pathway for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a proposed rule intended to streamline the current approval pathway for so-called novel medical devices employing new and advanced technologies.

The proposed rule, which was published in early December in the Federal Register, establishes regulations for the FDA’s De Novo classification process for medical devices. The De Novo process was initially introduced in 1997 and has been modified under both the FDA Safety and Innovation Act (FDASIA) and, more recently, the 21st Century Cures Act. Surprisingly, however, no specific regulations currently exist regarding the administration of the De Novo classification process.

The FDA says that the proposed rule sets out to establish the regulatory framework for the review and approval of medical devices under the De Novo process, thereby making the De Novo pathway “significantly more efficient and transparent,” and enabling the Agency to “protect patient safety while promoting innovations that can advance peoples’ health and function.”

Read the complete text of the FDA’s proposed rule on the De Novo classification process for medical devices as published in the Federal Register. Comments on the proposed rule must be filed by not later than March 7, 2019 through the Regulations.gov portal (www.regulations.gov). Commenters should reference docket number FDA-2018-N-0236.

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