Recognized standard
20417 First edition 2021-04 Corrected version 2021-12
FDA recognition 5-135 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-135 |
|---|---|
| Designation | 20417 First edition 2021-04 Corrected version 2021-12 |
| Title | Medical devices - Information to be supplied by the manufacturer |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: