Recognized standard
MM01-A3 (Replaces MM01-A2)
FDA recognition 7-237 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-237 |
|---|---|
| Designation | MM01-A3 (Replaces MM01-A2) |
| Title | Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 15, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This document provides general recommendations for all phases of the operation of a molecular genetics diagnostic laboratory. Clinical molecular testing has application to inherited and acquired medical conditions with genetic etiologies as well as variations associated with drug metabolism. In a… |
At a glance
- 1–9 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: