30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
This guidance clarifies what manufacturing method or process changes qualify for submission as 30-day notices versus other types of submissions (135-day PMA supplements or 75-day HDE supplements) for devices with approved PMAs or HDEs. It provides details on the content requirements and submission process for these notices.
Recommended Actions
- Determine if manufacturing change qualifies for 30-day notice versus other submission types
- Prepare complete submission package including:
- Clear identification as 30-day notice
- Description of change and rationale
- Validation data summary
- Quality system compliance statement
- Process monitoring procedures
- Supplier controls if applicable
- Submit electronic copy with paper cover letter and applicable user fee
- Wait 30 days before implementing change unless FDA indicates inadequacy
- If FDA deems notice inadequate, prepare 135-day PMA or 75-day HDE supplement as directed
- Document changes in annual report if they do not affect safety or effectiveness
- Maintain all validation data and quality system records related to the change
- Monitor implemented changes through routine quality system procedures
Key Considerations
Non-clinical testing
- Validation studies must be completed to demonstrate the manufacturing change does not significantly impact device operation
- Statistical rationale for sampling methods must be provided
- Test data analysis using valid statistical methods required
Labelling
- Labeling changes combined with manufacturing changes require 180-day PMA or 75-day HDE supplement instead of 30-day notice
Safety
- Changes must not affect device safety and effectiveness
- Quality control and process monitoring procedures must be established
- Purchasing controls required for new suppliers of critical components
Other considerations
- Complete description of change required
- Summary of supporting data/information needed
- Statement of compliance with 21 CFR Part 820 required
- User fees apply except for HDEs, pediatric devices, and government entities
- 30-day waiting period before implementing changes
- Changes involving finished device manufacturing sites do not qualify
Relevant Guidances
- Quality System Information Requirements for Premarket Submissions
- Design Controls for Medical Device Manufacturers
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
Related references and norms
- ISO 14644: Cleanrooms and associated controlled environments
- 21 CFR 820: Quality System Regulation
Original guidance
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- HTML / PDF
- Issue date: 2019-12-16
- Last changed date: 2021-01-26
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket Approval (PMA), Device & Drug Safety, Premarket, Biologics, HUD/HDE, Administrative / Procedural
- ReguVirta summary file ID: b484e27f5b2a62b0527ed8720b7a8224
This post is licensed under CC BY 4.0 by the author.