30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices

What You Need to Know? 👇

What is the difference between a 30-day notice and a PMA supplement for manufacturing changes?

A 30-day notice is for manufacturing procedure or method changes that affect safety/effectiveness, allowing distribution after 30 days unless FDA objects. PMA supplements are required for changes affecting device design, performance specifications, or material specifications, requiring 135-180 days review.

When can I use a 30-day notice instead of submitting a full PMA supplement?

You can use a 30-day notice for manufacturing procedure changes like sterilization parameters, automation of existing processes, supplier changes (same specifications), quality control testing modifications, and environmental condition changes that don’t alter device performance or design specifications.

What happens if FDA finds my 30-day notice inadequate?

FDA will notify you within 30 days via email or letter that a 135-day PMA supplement (or 75-day HDE supplement) is required. They will describe additional information or actions needed for acceptance of the manufacturing change.

Are there user fee exemptions for 30-day notices in medical device submissions?

Yes, exemptions include HDE submissions and supplements, PMAs/supplements intended solely for pediatric populations, and submissions by state or federal government entities (unless for commercial distribution). Standard 30-day notices for PMAs require user fees.

What documentation must be included in a 30-day notice submission?

Required: change description with pictures, data summary supporting the change, and statement of compliance with 21 CFR Part 820. Recommended: device description, manufacturing facility identification, change rationale, validation study summary, and statistical analysis of test data.

Can I add a new sterilization facility through a 30-day notice?

No, manufacturing/sterilization site changes for finished devices require a manufacturing site change supplement, not a 30-day notice. However, sterilization parameter changes within the same facility (like dose auditing or aeration time) may qualify for 30-day notices.

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What You Need to Do 👇

Recommended Actions

1. Determine if manufacturing change qualifies for 30-day notice versus other submission types
2. 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
3. Submit electronic copy with paper cover letter and applicable user fee
4. Wait 30 days before implementing change unless FDA indicates inadequacy
5. If FDA deems notice inadequate, prepare 135-day PMA or 75-day HDE supplement as directed
6. Document changes in annual report if they do not affect safety or effectiveness
7. Maintain all validation data and quality system records related to the change
8. 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

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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

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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 ID: b484e27f5b2a62b0527ed8720b7a8224