Regulations.gov document

Content of Premarket Submissions for Device Software Functions; Draft Guidance for…

Notice · FDA-2021-D-0775 · posted Nov 4, 2021

Key facts

Document ID FDA-2021-D-0775-0001
Title Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2021-D-0775
Posted Nov 4, 2021
Federal Register citation 86 FR 60838
FR document number 2021-24061
Comment period opens Nov 4, 2021
Comments due Feb 3, 2022
Effective date Nov 4, 2021

At a glance

  • 1–9 Pages
  • No Open for comment
  • 10–99 Public comments on this docket

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Regulations.gov documents

Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.

Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date:

Browse all Regulations.gov documents