The Medical Devices Introductory Course 2020

Submission Route

“ De Novo”

• Evaluation of automatic Class III designation - “ de novo ” is a reclassification petition procedure – Applies to low-medium risk devices where no “predicate” exists – Device is not subject to premarket approval – Filed directly with FDA (previously could only apply or “petition for reclassification of automatic class III” after FDA provided a “Not Substantially Equivalent” determination via the 510(k) process) – Fee* (FY 2020): ~ $102K [small business fee: ~ $26K] – Historically could be a slow process (usual range now variable 1-15m review, historically up to 36+m) • Special Controls apply for “de novo” devices, developed during the submission / classification process

• Quality Systems Regulations apply, including design controls • Establishment Registrations and Medical Device Listing is required * Fees were only introduced from FY 2018

The Organisation for Professionals in Regulatory Affairs

Submission Route

Pre-Market Approval

• PMA devices are Class III / high risk devices • PMA filing: –

Key content: all relevant technical, non-clinical and clinical data (mandatory) – Fee (FY 2020) ~ $341K [small business fee: $85K for <100K sales / if <30K sales, first PMA free] – 180 day review cycle (approval usually within 6-18 months) • Quality Systems Regulation apply - facility pre-market inspection • Establishment Registrations and Medical Device Listing is required • Constitutes FDA approval for placing device into interstate commerce • Provides PMA approval holder with stronger strategic market exclusivity position (no cross referencing or predication of PMA devices)

The Organisation for Professionals in Regulatory Affairs