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Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; 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 "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." This guidance document describes a means by which a full-field digital mammography (FFDM) system may comply with special controls that apply to these class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify these device types from class III into class II (special controls).
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Data sourced from Federal Register