Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements

What You Need to Know? 👇

What types of device modifications qualify for Real-Time PMA Supplements?

Minor changes to device design, software, labeling (not affecting indications), and sterilization methods qualify. The modification must be expected for that device type, validated using accepted methods, supported by pre-clinical testing, and typically require single-discipline review.

How long does FDA take to respond to Real-Time PMA Supplement requests?

FDA plans to respond within 14 days of receiving your Real-Time review request. If approved, meetings are typically scheduled within 30 days of your proposed submission date or the earliest mutually available date.

Are user fees required for Real-Time PMA Supplements?

Yes, user fees are required and must be paid upon submission. FDA places submissions on hold until payment is received and begins review only after confirming payment and receiving a valid electronic copy.

What should be included in a Real-Time PMA Supplement submission?

Include all planned device and labeling modifications, supporting test results, and a detailed risk assessment. The risk assessment should cover potential hazards, incremental and cumulative effects of modifications, and risk mitigation steps taken.

How far in advance should I submit before a Real-Time review meeting?

Submit your Real-Time PMA Supplement at least 3 weeks before the scheduled meeting. FDA typically reschedules meetings if submissions are received later to ensure reviewers have adequate preparation time.

What happens during a Real-Time review meeting with FDA?

You present device changes, testing results, and risk analysis. FDA discusses questions and comments, briefly adjourns for internal discussion, then provides verbal feedback the same day. A written decision letter follows via mail or email.

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What You Need to Do 👇

Recommended Actions

1. Contact the Assistant Director in the appropriate Review Division to discuss eligibility for real-time review
2. 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
3. Prepare submission package containing:
   • Detailed description of all modifications
   • Testing results
   • Comprehensive risk assessment
   • FDA’s response granting real-time review request
4. Submit eCopy with paper cover letter at least 3 weeks before scheduled meeting
5. Pay required user fee upon submission
6. 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

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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

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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 ID: fc28f9b470642fabb74647b2b97a76f9