FDA Guidance Documents
FDA guidance documents represent the agency's current thinking. They are not legally binding but provide important direction.
Software & Digital Health
| Guidance | Year |
|---|---|
| Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | 2023 |
| Predetermined Change Control Plans for ML-Enabled Medical Devices | 2024 |
| Software as a Medical Device (SaMD): Clinical Evaluation | 2017 |
| Content of Premarket Submissions for Device Software Functions | 2023 |
Clinical Studies
| Guidance | Year |
|---|---|
| Design Considerations for Pivotal Clinical Investigations | 2013 |
| Use of Real-World Evidence to Support Regulatory Decision-Making | 2017 |
| Benefit-Risk Determinations in Medical Device Premarket Approval | 2019 |
510(k) & De Novo
| Guidance | Year |
|---|---|
| The 510(k) Program: Evaluating Substantial Equivalence | 2014 |
| De Novo Classification Process | 2021 |
| Recommended Content and Format of Non-Clinical Bench Performance Testing | 2019 |
Biocompatibility
| Guidance | Year |
|---|---|
| Use of International Standard ISO 10993-1 | 2020 |