Recognized standard
MM21-1st Edition (Reaffirmed: January 2020)
FDA recognition 7-264 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-264 |
|---|---|
| Designation | MM21-1st Edition (Reaffirmed: January 2020) |
| Title | Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | This guideline provides recommendations for validation, verification, performance, and interpretation of nucleic acid microarrays used for cytogenetic applications to measure copy number imbalances and loss of heterozygosity. Both constitutional and oncology applications are addressed. |
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: