Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
This guidance explains when a PMA supplement should be submitted for manufacturing site changes (including processing, packaging, or sterilization site) of PMA-approved devices. It also outlines the documentation requirements and factors FDA considers when determining if a pre-approval inspection is necessary. The guidance applies only to devices with approved PMA, product development protocol, or HDE, and does not cover 510(k) devices, De Novo devices, or IDE devices.
Recommended Actions
- Determine if change requires site change supplement or 30-day notice based on guidance criteria
- Prepare required documentation package including:
- Device and site change descriptions
- Manufacturing diagrams and flows
- Process validation plans
- Control procedures
- Supplier documentation if applicable
- Assess likelihood of pre-approval inspection based on FDA factors
- Complete all validation activities before potential inspection
- Submit appropriate supplement type with complete documentation
- Wait for FDA approval before implementing site change
- Maintain compliance with QS regulation requirements throughout process
Key Considerations
Non-clinical testing
- Process validation or revalidation master plan and procedures must be provided
- Validation reports should be submitted when available
- All validation activities should be completed before inspection scheduling
Software
- Validation of software used in production or quality system where applicable must be documented
Safety
- Environmental and contamination control procedures must be provided if conditions could affect device safety
- Inspection, measuring and test equipment calibration procedures must be documented
- Incoming and final acceptance activities procedures must be provided
Other considerations
- Description of device, intended use, and nature of site change required
- Manufacturing site diagrams and flow diagrams needed
- Equipment and process descriptions affected by change
- List of applicable standards
- For new suppliers/contractors:
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Quality System Information Requirements for Premarket Submissions
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
Related references and norms
- 21 CFR Part 820: Quality System Regulation
- 21 CFR 814.39: PMA Supplements and Amendments
- 21 CFR 807.3: Establishment Registration and Device Listing
Original guidance
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- HTML / PDF
- Issue date: 2018-12-17
- Last changed date: 2020-10-22
- Status: FINAL
- Official FDA topics: Medical Devices, Postmarket, Premarket Approval (PMA), Biologics
- ReguVirta summary file ID: a62ca8e2ed16fcf68dcf26da22be8ab8
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