Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
This guidance provides recommendations for determining the type of regulatory submission required when modifying a PMA-approved Class III medical device. It covers changes to device design, labeling, manufacturing process, or manufacturing location that may affect safety and effectiveness. The guidance explains the decision-making process and criteria for selecting between different types of submissions: traditional PMA, panel-track supplement, 180-day supplement, real-time supplement, special PMA supplement, 30-day notice, manufacturing site change supplement, or periodic reports.
Recommended Actions
- Identify the modification and reason for change
- Conduct risk analysis to assess impact on safety and effectiveness
- Define required testing data to demonstrate continued safety and effectiveness:
- Clinical data needs
- Preclinical testing requirements
- Manufacturing validation needs
- Select appropriate submission type based on:
- Extent of clinical/preclinical data needed
- Significance of the change
- Impact on safety and effectiveness
- Manufacturing considerations
- Prepare submission with:
- Clear description of changes
- Supporting test data
- Risk analysis
- Updated labeling if needed
- Consider consulting FDA before submission if unclear about appropriate pathway
- Monitor implementation and document changes according to quality system requirements
- Report minor changes in annual reports if no supplement needed
Key Considerations
Clinical testing
- Substantial clinical data needed for panel-track supplements involving new indications or significant changes
- Limited confirmatory clinical data may be needed for some 180-day supplements
- No clinical data typically needed for real-time supplements
Non-clinical testing
- New preclinical testing needed for traditional PMAs and 180-day supplements
- Limited preclinical testing may be needed for panel-track supplements
- Single discipline preclinical testing acceptable for real-time supplements
Software
- Software modifications may require 180-day supplements if significant
- Minor software changes may qualify for real-time supplements
Labeling
- Significant labeling changes require 180-day supplements
- Minor labeling changes may qualify for real-time supplements
- Safety-enhancing labeling changes may use Special PMA Supplement - Changes Being Effected
Safety
- Changes that enhance safety without affecting effectiveness may use Special PMA Supplement
- Safety-related manufacturing changes may qualify for 30-day notice
Other considerations
- Manufacturing site changes require specific manufacturing site change supplements
- Minor changes not affecting safety or effectiveness can be reported in annual reports
- Pre-approval inspections may be required for some manufacturing changes
Relevant Guidances
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- Quality System Information Requirements for Premarket Submissions
- Content of Premarket Submissions for Device Software Functions
Related references and norms
- IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety
Original guidance
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- HTML / PDF
- Issue date: 2008-12-11
- Last changed date: 2022-02-08
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Premarket Approval (PMA), Biologics
- ReguVirta summary file ID: 6ed6b419b5f1b628f51b76b9c507a326
This post is licensed under CC BY 4.0 by the author.