Medical Devices Used in Recovery, Isolation, and Delivery of Regenerative Medicine Advanced Therapies
This guidance applies to medical devices used in the recovery, isolation, or delivery of Regenerative Medicine Advanced Therapies (RMATs). It covers devices ranging from simple surgical instruments to complex automated cell collection systems, including devices that may be constituent parts of combination products. The guidance excludes device scaffolds combined with cellular products, general use manufacturing equipment, and devices not directly used in RMAT recovery, isolation, or delivery (like diagnostics).
Recommended Actions
- Determine appropriate regulatory pathway based on device classification and risk level
- Evaluate need for IDE application if clinical evidence is required
- Generate necessary compatibility data between device and intended RMAT(s)
- Document scientific rationale if leveraging existing compatibility data
- Develop appropriate labeling specifying device use characteristics and limitations
- Consider submitting Q-Submission to get FDA feedback before formal application
- Assess whether single or separate applications are appropriate for combination products
- Apply least burdensome principles when preparing regulatory submissions
- Maintain documentation of device-RMAT interaction studies and risk assessments
- Consider potential for broader device use across multiple RMATs when appropriate
Key Considerations
Clinical testing
- Clinical evidence may be necessary through an IDE when required to support marketing authorization
- Valid scientific evidence is required to determine reasonable assurance of safety and effectiveness
- Clinical data from one product may potentially support aspects of other related product applications
Non-clinical testing
- Testing needed to assess interactions between devices and RMATs
- Compatibility data required prior to clinical trials
- May need to repeat testing for each new device-RMAT combination
Labelling
- Must specify defined characteristics of compatible delivery devices
- May require specific labeling when device is limited to use with particular RMAT(s)
- Changes to labeling may be needed for approved products when used in combination
Biocompatibility
- Must consider interactions between cells and devices that can impact cell viability, differentiation, activation state
- Physical and chemical compatibility between device and RMAT must be demonstrated
Safety
- Must demonstrate reasonable assurance of safety through valid scientific evidence
- Safety considerations include impact on cell viability, differentiation potential, and functionality
- Risk assessment needed for device-RMAT interactions
Other considerations
- Device classification (Class I, II, or III) determines regulatory pathway
- Least burdensome approach applied to regulatory requirements
- Single application review for combination products when appropriate
- Factors affecting device use with single vs multiple RMATs include:
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Least Burdensome Principles for Medical Device Regulation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Current Good Manufacturing Practice Requirements for Combination Products
Related references and norms
- 21 CFR Part 3: Product jurisdiction and combination products
- 21 CFR Part 807: Establishment registration and device listing
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 814: Premarket approval of medical devices
- 21 CFR 860.7: Determination of safety and effectiveness
Original guidance
- Medical Devices Used in Recovery, Isolation, and Delivery of Regenerative Medicine Advanced Therapies
- HTML / PDF
- Issue date: 2019-02-15
- Last changed date: 2019-07-29
- Status: FINAL
- Official FDA topics: Medical Devices, Gene Therapy, Combination Products, Biologics
- ReguVirta summary file ID: 7514e10ff902bb1bb7b7506a4b33651f
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