Premarket Device Notification

Preferred Label : Premarket Device Notification;

NCIt synonyms : Premarket Notification Submission; Premarket Device Notification (510k); PMN;

NCIt related terms : Premarket Notification 510(K); Premarket Notification; 510(k);

NCIt definition : A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).;

Alternative definition : CDISC-GLOSS: 510(k). Premarket Notification (PMN) required for certain medical devices. See http://www.fda.gov/cdrh/510khome.html.; PQCMC: PQCMC data submitted for a premarket 510(k) submission.;

Details

Origin ID

C80442;

UMLS CUI

C2825189;

Automatic exact mappings (from CISMeF team)
- piecemeal microautophagy of the nucleus [GO term]
Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
- FDA CDRH GUDID Terminology [NCIt concept]
- FDA Pharmaceutical Quality/CMC Terminology [NCIt concept]
- FDA Structured Product Labeling Terminology [NCIt concept]
- PQ/CMC Stability Study Reason Terminology [NCIt concept]
- SPL Marketing Category Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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