FDA guidance
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical…
FDA guidance · Final · issued Sep 25, 2020
Key facts
| Title | Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Sep 25, 2020 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Biologics Evaluation and Research, Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Biologics, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2019-D-3805 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents