The Medical Devices Introductory Course 2020

Submission Route

Exempt Devices:

• Exempt from Premarket Notification or Approval (no pre-market submission to FDA required) • Most Exempt Devices fall in Class I but some are Class II devices • Establishment Registration and Device Listing is required • Quality Systems Regulations: – Class I devices may also be exempt from some elements of the Quality Systems Regulations, such as Design Controls – General Controls and Complaint Files, however, apply to all devices – General Controls and Complaint Files include labelling and medical device reporting (MDR) requirements

The Organisation for Professionals in Regulatory Affairs

Submission Route

Premarket Notification “510(k)”

• Determination of Substantial Equivalence (SE) –

Based on intended use and technological characteristics of “Predicate” 510(k) device(s) (or “ Pre- amendment ” device in commercial distribution before 1976)

• 510(k) filing: –

Key content: substantial equivalence discussion , indications for use, summary of technical characteristics (clinical data not mandatory) – Fee (FY 2020) ~ $12K [small business (<$100K sales) fee ~ $3K] – 90 day review cycle (clearance usually within 3-9 months) • Constitutes FDA “ clearance ” not approval for placing device into interstate commerce • Most 510(k) devices fall in Class II but some are Class I, Class III or Unclassified devices

• Quality Systems Regulations apply, including design controls • Establishment Registration and Medical Device Listing is required

The Organisation for Professionals in Regulatory Affairs