The Medical Devices Introductory Course 2020

Submission Route

Humanitarian Device Exemption

• HDE applies to “Humanitarian Use Devices” (HUD’s) intended for <8,000 patients in US / year

• Two stage process: (1) obtain HUD status from FDA Office of Orphan Product Development (statutory 45 day timeframe); (2) obtain HDE from CDRH

HDE filing: – Same as PMA, except: exempt from user fee and from effectiveness requirements (i.e.: clinical evidence limited to show probable benefit outweighs risk)

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– 105 day review cycle (assuming no additional data requirements or amendments)

• Must label as “HUD” and limited effectiveness data

• Requires IRB approval for use in facilities and profit restrictions apply based on research and development and fabrication / distribution costs

The Organisation for Professionals in Regulatory Affairs

Implement Quality Systems

Quality System Regulations (“QSRs”) [21 CFR 820]

• Apply to all devices (excluding specific elements for some “Exempt Devices”) • Includes requirements for: – Management Responsibility – Design Controls – Document Controls – Purchasing Controls – Identification and Traceability – Acceptance Activities – Non-Conforming Product – Corrective and Preventive Action (CAPA) – Labeling and Packaging Controls – Handling, Storage, Distribution and Installation – Records (including Complaint Handling) – Servicing – Statistical Techniques • QSRs apply post-market but also need to be in place for clinical supplies and product development (use of design controls and human factors) • FDA inspections (periodic or for cause) conducted against QSRs