Guidance by Device Type & Class
FDA publishes guidance documents specific to device types and medical specialties. The following is an index of key guidance areas — all documents are available through the FDA Guidance Search.
How to find device-specific guidance
- Go to FDA Guidance Documents Search
- Use keyword search (e.g., "pacemaker," "glucose meter," "infusion pump")
- Filter by Product or Topic to narrow results
- Check publication date — prioritise the most recent finalised guidance
Key guidance by specialty area
Cardiovascular (21 CFR Part 870)
- Testing Recommendations for the Evaluation of Vascular Graft Prostheses
- Guidance on Premarket Studies for Cardiovascular Devices — Structural Heart Disease
- Non-Clinical Testing of Heart Valves
- Pacemaker and Lead Testing Guidance
Orthopaedic (21 CFR Part 888)
- Guidance for Testing Orthopaedic Implants with Modified Metallic Surfaces
- Total Hip Replacement and Unicompartmental Knee Replacement Design Validation
- Spinal System 510(k) Submissions
In Vitro Diagnostics / IVD (21 CFR Parts 862–866)
- Principles of Performance Studies for Diagnostic Reagents
- Statistical Guidance for Analytical Procedures in IVD Device Submissions
- Considerations for the Design, Development, and Analytical Validation of NGS-Based IVDs
- CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
Software / Digital Health (all device types)
- Software as a Medical Device (SaMD): Clinical Evaluation (IMDRF-aligned)
- Factors to Consider When Making Benefit-Risk Determinations — Software
- Artificial Intelligence/Machine Learning (AI/ML) Action Plan
- Predetermined Change Control Plans for ML-Enabled Devices
- Clinical Decision Support Software (2022)
Combination products
- How to Write a Request for Designation (RFD)
- Classification of Products as Drugs and Devices & Additional Product Classification Issues
Reprocessing / sterilisation
- Reprocessing of Single-Use Devices — Guidance for Industry and FDA Staff
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
Human factors / usability
- Applying Human Factors and Usability Engineering to Medical Devices (2016)
- Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
Guidance for specific submission types
| Submission type | Key guidance document |
|---|---|
| 510(k) | The 510(k) Program: Evaluating Substantial Equivalence (2014) |
| De Novo | De Novo Classification Request (2021) |
| PMA | PMA Application Contents (2010) |
| IDE | IDE Early Collaboration Meetings (1996) |
| Q-Submission | Q-Submissions Program: Frequently Asked Questions (2019) |