Least Burdensome Principles for Medical Device Regulation
This guidance applies to all products meeting the statutory definition of a medical device, including device constituent parts of combination products. It covers all regulatory activities throughout the total product lifecycle, including premarket submissions, clinical studies, postmarket surveillance, compliance interactions, and guidance document development.
What You Need to Know? 👇
What is the FDA’s definition of “least burdensome” in medical device regulation?
The FDA defines “least burdensome” as the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. This considers the type of information, different approaches to generating information, and when during the total product lifecycle information should be provided.
How can real-world evidence be used to support medical device submissions?
Real-world evidence (RWE) derived from electronic health records, registries, and claims data can support both premarket and postmarket decisions. FDA has approved devices using registry data, accepted database information for genetic testing, and leveraged RWE for expanded indications, reducing the need for traditional clinical studies.
What are the key guiding principles for applying least burdensome approaches?
The seven guiding principles include: requesting minimum necessary information, submitting well-organized materials, using efficient means to resolve issues, providing right information at right time, designing approaches to fit technology, leveraging international data, and applying principles in harmonization efforts while maintaining excellent customer service.
When can nonclinical data replace clinical studies in device submissions?
Nonclinical data including benchtop models, computer modeling and simulations, tissue phantoms, and animal studies can replace clinical data when testing modalities are representative of clinical performance. FDA follows a bottom-up approach, first considering descriptive information, then nonclinical testing, before requesting clinical data.
How does the least burdensome concept apply to postmarket surveillance?
The concept balances premarket and postmarket information needs through tools like alternative summary MDR reporting, electronic submission systems, and reliance on Quality System regulations. FDA considers whether safety questions can be efficiently answered postmarket rather than requiring extensive premarket data collection.
What role do international harmonization efforts play in least burdensome regulation?
International harmonization through IMDRF participation, voluntary consensus standards recognition, and programs like MDSAP reduces regulatory burden by allowing manufacturers to meet multiple jurisdictions’ requirements without duplicating efforts. This includes standardized submission formats and unified audit programs across regulatory authorities.
What You Need to Do 👇
Recommended Actions
- Implement early engagement with FDA to discuss least burdensome approaches
- Consider alternative data sources before conducting new clinical studies
- Evaluate opportunities to leverage existing data and documentation
- Use risk-based approaches to determine appropriate level of evidence needed
- Consider postmarket data collection to reduce premarket requirements when appropriate
- Utilize international standards and harmonization opportunities
- Submit well-organized, clear, and concise information focused on regulatory requirements
- Implement efficient processes for regulatory submissions and reporting
- Consider benefit-risk principles in regulatory decision-making
- Maintain open communication channels with FDA throughout product lifecycle
Key Considerations
Clinical testing
- Alternative sources of clinical data should be considered when appropriate (peer-reviewed literature, OUS data, real-world evidence, case histories)
- Less burdensome study designs should be used when possible (historical controls, non-comparative studies, subject as own control, adaptive designs)
- Balance between premarket and postmarket data collection should be considered
Non-clinical testing
- Nonclinical data should be considered as replacement for clinical data when appropriate
- Computer modeling and simulations can be used to support safety and effectiveness
- Just-in-time testing approach can be used for early feasibility studies
Labelling
- Alternative labeling approaches should be considered if original labeling is not supported by evidence
- Addition of specific warnings/precautions may provide sufficient risk mitigation
Biocompatibility
- Can leverage OUS clinical data or large animal safety studies for certain biocompatibility endpoints
- Can use rationales based on materials properties, chemistry, and processing as alternatives to repeat testing
Safety
- Benefit-risk assessments should be used in regulatory decision-making
- Greater uncertainty may be acceptable when probable benefits are high or probable risks are low
Other considerations
- Use most efficient means to resolve regulatory questions (streamlined processes, interactive approaches)
- Leverage international harmonization and standards when possible
- Consider appropriate balance between premarket and postmarket requirements
- Reduce administrative burden through bundling submissions and electronic processes
Relevant Guidances đź”—
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Benefit-Risk Determinations for Medical Device Premarket Review
- Developing and Responding to Medical Device Marketing Application Deficiencies
Related references and norms đź“‚
- 21 CFR Part 820: Quality System Regulation
- 21 CFR Part 807: Establishment Registration and Device Listing
- 21 CFR Part 803: Medical Device Reporting