Medical Device Registration - FDA (510(k), De Novo and PMA), with AI

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01

Course description

A comprehensive course on the FDA (CDRH) medical device regulatory system, including risk classification, 510(k), De Novo and PMA regulatory pathways, the Quality Management System Regulation (QMSR, formerly 21 CFR 820), establishment registration and listing.

02

Course objective

Prepare participants to manage FDA medical device regulatory processes, selecting the appropriate pathway, preparing robust submissions and anticipating technical and review requirements (AI requests).

03

Course programme

40h of in-depth learning
  1. 01

    FDA and CDRH structure

  2. 02

    Classification (Classes I, II, III) and product codes

  3. 03

    The 510(k) pathway: predicate devices and substantial equivalence

  4. 04

    The De Novo pathway for low- to moderate-risk devices without a predicate

  5. 05

    The PMA pathway and clinical requirements

  6. 06

    QMSR (harmonisation with ISO 13485) and 21 CFR Part 11

  7. 07

    Establishment registration, listing and UDI in the USA

04

Who can attend?

  • Regulatory Affairs, Quality and R&D professionals, consultants and manufacturers seeking to market medical devices in the United States.