Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule,” by Nick Paul Taylor.

Following is an excerpt:

Dive Brief:

  • FDA has issued a final rule intended to clarify and formalize the De Novo process that allows some medical devices without a predicate to bypass the premarket approval pathway.
  • The medtech industry welcomed the broad goals of the proposed rule published late in 2018 but pushed back hard against some of its provisions, notably with regard to FDA's plans to carry out premarket manufacturing inspections.
  • FDA, while making some tweaks to the draft, held firm on the main points of friction with the medtech industry, arguing that it is legal and necessary to inspect some facilities as part of the De Novo process.

Dive Insight:

Early last year, AdvaMed sent feedback that welcomed FDA's aim to enhance the "regulatory clarity and predictability" of the De Novo pathway through the proposed rule but found fault with the specifics. The medtech trade group raised concerns the rule would impose requirements that replicate the PMA process. As AdvaMed saw it, a "drift towards PMA review is discordant with the De Novo classification process' purpose" and would lead to "unnecessary expenditures."

"The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green in an email.

Thompson called that "a real stretch," but the FDA resisted siding with industry.

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