Regulations.gov document

Use of Standards in the Food and Drug Administration’s Regulatory Oversight of Next…

Notice · FDA-2016-D-1270 · posted Jul 8, 2016

Key facts

Document ID FDA-2016-D-1270-0001
Title Use of Standards in the Food and Drug Administration’s Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2016-D-1270
Posted Jul 8, 2016
Federal Register citation 81 FR 44614
FR document number 2016-16201
Comment period opens Jul 8, 2016
Comments due Oct 7, 2016
Effective date Jul 8, 2016

At a glance

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

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