Regulations.gov document

Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted…

Rule · FDA-2019-N-5610 · posted Jan 22, 2020

Key facts

Document ID FDA-2019-N-5610-0001
Title Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer
Document type Rule
Subtype Final Rule
Agency FDA
Docket FDA-2019-N-5610
Posted Jan 22, 2020
Federal Register citation 85 FR 3540
FR document number 2020-00497
CFR 21 CFR Part 892
Comment period opens Jan 22, 2020
Effective date Jan 22, 2020

At a glance

  • 1–9 Pages
  • None Public comments on this docket

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