ActiveRegulation
Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
Health and Human Services Department, Food and Drug Administration
NAICS 325412
Source: Federal Register
OverviewIntelligenceProposals
Key Details
- Posted Date
- NAICS Code
- 325412
- Source
- Federal Register
- Contract Type
- regulation
Description
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices." This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations.
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Data sourced from Federal Register