FDA guidance

Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for…

FDA guidance · issued Sep 26, 1994

Key facts

Title Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance
Issue date Sep 26, 1994
Document on fda.gov wayback.archive-it.org

At a glance

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

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

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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