De Novo Classification Final Rule Comes Into Effect Next Year – Food, Medicines, Healthcare, Life Sciences

United States: The final rule of the De Novo classification will come into force next year

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Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York City, contributed to the writing of this article.

On Tuesday, December 14, 2021, the United States Food and Drug Administration (FDA) hosted a webinar on the final rule, the medical device de novo classification process, and related guidance document updates. The final rule, which comes into effect on January 3, 2022, codifies the De Novo medical device classification process by adding new regulations to 21 CFR Part 860, Subpart D. Dr. Peter Yang, De Novo Program Lead at the FDA Center for Devices and Radiological Health (CDRH), led the webinar. Dr Yang described the new De Novo regulations, explained how regulations may or may not change the current De Novo review process, and answered questions from various interested parties.

A De Novo application is a type of pre-market submission, asking the FDA to classify a new device as Class 1 or Class 2 based on a determination of reasonable assurance of safety and efficiency (RASE). If the De Novo application is accepted, the FDA creates a new classification rule and the De Novo device can serve as the first predicate device of its kind. Subsequent requests will be a 510 (k). While the final rule largely reflects the current review process, the FDA has highlighted a few areas that may be of interest to stakeholders.

  • Refusal to Accept (RTA) Checklist. The most significant change is the updated Acceptance Checklist. 21 CFR 862.220 lists the contents of the De Novo application, and 21 CFR 862.230 provides the acceptance review process. The current RTA checklist has two parts: a mandatory checklist (Annex A) and a recommended checklist (Annex B). With this new regulation, almost all the elements of Annex A and Annex B are now mandatory elements. Specifically, the new checklists add things like pre-submission, classification summary (eligibility analysis), and device labeling. The FDA will perform an acceptance review within 15 days of receipt. The file is automatically accepted if the recipe review is not carried out.
  • Classification procedure. The FDA aims to achieve three objectives when considering a De Novo application: (1) determine whether the likely benefits outweigh the likely risk, (2) identify the likely health risks of the device / product, and (3) based on health risks, determining the level of regulatory control needed to mitigate the risk. If the FDA concludes that general controls or both general and special controls will provide reasonable assurance of safety and efficacy, a De Novo application will be granted. The full review will take 150 FDA days, a performance target set by MDUFA IV, which is different from the statutory 120-day FDA deadline.
  • Manufacturing inspection before marketing. The final rule gives the FDA new authority to perform a pre-market manufacturing inspection, codified in 21 CFR 860.240. The FDA specifies that the inspection will only affect “a small percentage” of De Novo requests and is limited to (1) data integrity issues and (2) quality system regulation when devices have processes. critical or new manufacturing processes that may affect the safety and effectiveness of the product. For example, if a device proposes to use a new sterilization technique, the FDA may want to inspect the facility to understand how the sterilization process works. Sponsors will receive notification prior to any inspection without specific delay.
  • Marketing language. It is important to remember that a De Novo application is not a pre-market approval (PMA) and is not subject to the same approval requirements as in a PMA. The FDA has recommended that De Novo marketing language include “de Novo granted”, “De Novo granted” or “market authorization granted”. Similar to other non-PMA devices, the FDA does not recommend “FDA approved” for De Novo devices.

Due to the general nature of this update, the information provided here may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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