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FDA Update: Inspections Return, De Novo Classification and ISO 13485 Added to Agenda

FDA has made multiple announcements in recent weeks about its forthcoming priorities, including the return of domestic inspections and decisions on various final rules.

Domestic Inspections are Returning

FDA issued a statement about preparations to resume domestic inspections, guided by a new a risk-assessment system, using CDC guidance to inform efforts related to workplace exposures to COVID-19. FDA developed the COVID-19 Advisory Rating system to help determine when and where it is safest to conduct prioritized domestic inspections.

The agency seeks to restart on-site inspections during the week of July 20. However, resuming these inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines established by those state and local governments.

FDA’s Regulatory Agenda Update

One of the final rules of FDA’s Spring 2020 regulatory agenda relates to the medical device De Novo classification process, which has been on the agency’s list for several years. FDA seeks to publish a final rule on De Novo device classification in September.

A Notice of Proposed Rulemaking (NPRM) was published in late 2018, with comments required by 1Q19. Under the proposed rule, FDA set out procedures and criteria for the De Novo process, intending to increase transparency and predictability for device makers. By clarifying and making more efficient De Novo request requirements, FDA expects that the rule would reduce time and costs associated with reviewing requests and generate net benefits of cost savings.

The De Novo process provides a pathway to classify novel medical devices for which there is no legally marketed predicate device. De novo classification is a risk-based classification process, and devices granted a De Novo request can serve as a predicate device for a later 510(k) submission. 

In comments, device industry representatives expressed concerns that the proposed rule did not achieve what it set out to do, which was to “limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval.”

Further, commenters noted that the proposed requirements were either identical or nearly identical to those required of the premarket approval (PMA) process, potentially negating any advantage to De Novo.

Only three orthopedic products have received the De Novo classification: IlluminOss Medical's IlluminOss Bone Stabilization System, Intellirod Spine's LOADPRO™ Intraoperative Rod Strain Sensor and Woven Orthopedic Technologies' OGmend Implant System.

Two other proposed rules that FDA plans to issue in the next six months include:

  • Harmonizing and Modernizing Regulation of Medical Device Quality Systems. FDA intends to revise and update the quality standards for medical devices to ISO 13485:2016. Revisions will reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.
  • Biologics Regulation Modernization. Regulations will be updated to clarify existing requirements and procedures related to Biologic License Applications and to promote goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.

Additionally, in June, the Medical Device Innovation Consortium held a CDRH Town Hall where the agency discussed updates to multiple initiatives, including Advanced Manufacturing and Case for Quality. At the time, CDRH Director Jeffrey E. Shuren, M.D., J.D., stressed FDA will continue to prioritize important projects while juggling its response to COVID-19.



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