Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
This guidance clarifies FDA's policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs). It outlines how FDA considers postmarket information in determining the extent of data needed in the premarket setting while still meeting the statutory standard of reasonable assurance of safety and effectiveness.
What You Need to Know? 👇
What is the FDA’s approach to balancing premarket and postmarket data collection for PMA devices?
FDA considers postmarket controls to reduce premarket data requirements while maintaining reasonable assurance of safety and effectiveness. This approach facilitates timely patient access to important medical technologies without compromising safety through appropriate postmarket monitoring and studies.
When can FDA accept postmarket data collection instead of premarket studies for Class III devices?
FDA may accept postmarket data collection for mature technologies, urgent public health needs, confirming mitigation effectiveness, assessing rare adverse events, or evaluating long-term performance when the overall benefit-risk profile supports approval with acceptable uncertainty levels.
What are the typical conditions of approval FDA imposes when relying on postmarket data?
FDA may require post-approval studies, periodic reporting on safety and effectiveness, specific labeling requirements describing uncertainties, device restrictions, or registry participation. These conditions ensure continued evaluation of the device’s benefit-risk profile in real-world use.
How does the least burdensome provision apply to postmarket data collection strategies?
The least burdensome provision requires FDA to request only necessary clinical data for effectiveness demonstration. Postmarket controls should be considered to reduce premarket data extent while meeting statutory approval standards, representing the most appropriate investment of resources.
What enforcement actions can FDA take if sponsors fail to complete required post-approval studies?
FDA may issue safety communications, convene advisory panels, pursue administrative enforcement including seizure or injunction, impose civil money penalties, or withdraw PMA approval if sponsors fail to meet post-approval study requirements or timelines.
How does FDA’s Expedited Access Pathway relate to postmarket data collection for unmet medical needs?
The Expedited Access Pathway allows FDA to accept greater pre-approval uncertainty for devices addressing unmet medical needs in life-threatening conditions. This may include smaller trials, non-randomized studies, or deferring certain data collection to postmarket confirmatory studies.
What You Need to Do 👇
Recommended Actions
- Evaluate if device qualifies for postmarket data collection based on maturity of technology, public health need, or other factors
- Submit Pre-Submission to discuss potential postmarket data collection strategy with FDA
- Design appropriate post-approval study protocol considering:
- Sample size requirements
- Market conditions
- Recruitment challenges
- Risk level of device
- Develop labeling that clearly describes uncertainties and data limitations
- Establish processes to:
- Monitor and report postmarket data
- Implement labeling changes if needed
- Track post-approval study progress
- Meet periodic reporting requirements
- Create contingency plans for potential postmarket actions including:
- PMA supplements
- Labeling updates
- Safety communications
- Regulatory responses
- Maintain documentation of compliance with post-approval requirements
Key Considerations
Clinical testing
- Clinical data collection can be shifted to postmarket setting for mature technologies with well-understood benefits and risks
- Post-approval studies may be appropriate to confirm mitigation effectiveness for known risks
- Long-term performance assessment may be conducted postmarket
- Rare adverse events may be evaluated postmarket when FDA has low uncertainty about benefit-risk balance
- Clinical confirmation of bench data may be collected postmarket
Non-clinical testing
- Non-clinical testing may be conducted postmarket to confirm bench data
- Long-term mechanical testing may be deferred to postmarket for well-understood device types
Labeling
- Labeling must include description of uncertainty about benefits/risks and extent of data supporting approval
- Labeling changes may be required based on postmarket data
- FDA may impose labeling requirements as condition of approval
Safety
- Safety data collection may be shifted postmarket for mature technologies
- Rare safety events may be evaluated postmarket
- Post-approval studies may be required to assess long-term safety
Other considerations
- FDA may accept greater pre-approval uncertainty for devices addressing unmet medical needs
- Post-approval studies must be completed within agreed timeframes
- FDA may require registry data collection
- FDA may take enforcement action if post-approval requirements are not met
- FDA may withdraw PMA approval based on postmarket data
Relevant Guidances 🔗
- Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
Related references and norms 📂
- 21 CFR 814: Premarket Approval of Medical Devices
- 21 CFR 822: Postmarket Surveillance
- 21 CFR 860: Medical Device Classification Procedures