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US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.

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July 21, 2020

The US Food and Drug Administration has identified several final rules, guidances and other actions the agency plans to pursue as part of its Spring 2020 Agency Rule List, including revised quality standards to align with ISO 13485:2016  as well as a finalized classification scheme for De Novo medical devices.

Harmonizing FDA QSR requirements with ISO 13485:2016

FDA first proposed revising its current Quality System Regulations (QSR) under 21 CFR Part 820 to more closely align with the international ISO 13485:2016 standard in May 2018. The ISO 13485 quality standard forms the basis for quality management system requirements in the European Union, Japan, Canada and other medical device markets; FDA plans to issue a notice of proposed rulemaking in October 2020 establishing US quality system requirements based more closely on ISO 13485:2016, according to the agency’s Rule List.

Through the proposed rule, FDA intends to provide less onerous medical device market pathways for manufacturers that currently must meet significant FDA QSR requirements particular to the US in order to obtain 510(K) premarket notification, Premarket Approval (PMA) or other registration.

More transparent De Novo classification processes for cutting-edge devices

Second, FDA is preparing a final rule to establish a more transparent classification scheme for premarket applicants filing De Novo requests for novel and cutting-edge devices. Expected in September 2020, the final De Novo classification rule will formalize processes, procedures and criteria for manufacturers whose devices do not fall clearly into existing FDA classification categories.

“By clarifying and making more efficient the De Novo request requirements, we expect the rule would reduce the time and cost associated with reviewing De Novo requests and generate net benefits in the form of cost savings,” states FDA.

First proposed in December 2018, the De Novo classification system was devised to help manufacturers better determine whether their devices warrant De Novo requests after FDA set hefty user fees for such requests in 2017.

Learn more about US FDA medical device regulations at Emergo by UL:

  • US FDA QSR consulting (21 CFR Part 820) for medical device manufacturers
  • US FDA medical device classification consulting

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