Regulations.gov document
Reference 3-Use of Real-World Evidence to Support Regulatory Decision-Making for Medical…
Supporting & Related Material · FDA-2014-N-1210 · posted Mar 5, 2019
Key facts
| Document ID | FDA-2014-N-1210-3435 |
|---|---|
| Title | Reference 3-Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2014-N-1210 |
| Posted | Mar 5, 2019 |
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