FDA guidance

Guidance for the Content of Premarket Notifications for Biopsy Devices Used in…

FDA guidance · Final · issued Feb 9, 1993

Key facts

Title Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology
Status Final
Issue date Feb 9, 1993
Center Center for Devices and Radiological Health
Issuing office Center for Devices and Radiological Health
Communication type Guidance Document
Regulated product Medical Devices
Topics Premarket
Docket number FDA-2020-D-0957
Open for comment No

At a glance

  • 10–99 Product codes referenced
  • 1–9 Recognized standards referenced

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About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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