Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
This guidance outlines the real-time review process for PMA supplements, specifically focusing on minor changes to approved medical devices. It provides information about the criteria, procedures for requesting and submitting real-time PMA supplements.
Recommended Actions
- Contact the Assistant Director in the appropriate Review Division to discuss eligibility for real-time review
- Submit email request for real-time review including:
- Contact information
- PMA document number
- Target submission date
- Proposed meeting dates
- Reason for submission
- Brief explanation of changes
- Preferred meeting type
- Prepare submission package containing:
- Detailed description of all modifications
- Testing results
- Comprehensive risk assessment
- FDA’s response granting real-time review request
- Submit eCopy with paper cover letter at least 3 weeks before scheduled meeting
- Pay required user fee upon submission
- Prepare for interactive review process including potential meetings or other communications with FDA
Key Considerations
Non-clinical testing
- Changes must be validated according to accepted scientific principles and test methods
- Pre-clinical or animal testing should adequately support the changes
- No new clinical data should be required
Software
- Minor software changes are eligible for real-time review
Labelling
- Changes to instructions for use, warnings, or precautions that do not affect indications or contraindications
- Minor labeling changes are eligible
Safety
- Must include detailed risk assessment of all potential hazards
- Must consider both incremental modification and cumulative effects of preceding modifications
- Must identify steps taken to minimize additional risks
Other considerations
- Changes should be expected within the product line
- Review should typically involve a single scientific discipline
- Changes to sterilization and packaging methods are eligible
- User fee is required upon submission
- Electronic copy (eCopy) is mandatory with a signed paper cover letter
- Interactive review process with potential face-to-face meetings, teleconferences, or written responses
Relevant Guidances
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
Related references and norms
- No specific norms or ISO standards mentioned in the guidance
Original guidance
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- HTML / PDF
- Issue date: 2019-12-16
- Last changed date: 2020-03-24
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket Approval (PMA), Device & Drug Safety, Premarket, Biologics, Administrative / Procedural
- ReguVirta summary file ID: fc28f9b470642fabb74647b2b97a76f9
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