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Regulatory Submissions

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff

January 6, 2021
Regulatory Submissions

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff

September 25, 2018
Clinical Trial Guidance

Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff

February 21, 2018
Software

Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff

December 8, 2017
Regulatory Submissions

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices : Guidance for Industry and Food and Drug Administration Staff

August 31, 2017
Clinical Trial Guidance

Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

January 13, 2017
Regulatory Submissions

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff

July 28, 2014
Biologics/IVD

In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions: Guidance for Industry and FDA Staff

June 25, 2010
Regulatory Submissions

Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 – Guidance for Industry and for FDA Reviewers

August 9, 2000
Regulatory Submissions

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff

February 28, 2001
Medical Device

Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff

April 19, 2001
Clinical Trial Guidance

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

May 29, 2001
Regulatory Submissions

Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff

July 6, 2001
Regulatory Submissions

Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA

July 30, 2001
Software

General Principles of Software Validation: Guidance for Industry and FDA Staff

January 11, 2002
Regulatory Submissions

Determination of Intended Use for 510(k) Devices – Guidance for CDRH Staff (Update to K98-1)

December 3, 2002
Quality System

Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff

February 3, 2003
Regulatory Submissions

Pediatric Expertise for Advisory Panels – Guidance for Industry and FDA Staff

June 3, 2003
Regulatory Submissions

Premarket Approval Application Modular Review: Guidance for Industry and FDA Staff

November 3, 2003
Regulatory Submissions

Premarket Notification [510(k)] Submissions for Chemical Indicators – Guidance for Industry and FDA Staff

December 19, 2003
Regulatory Submissions

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff

June 2, 2004
Regulatory Submissions

Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter

November 8, 2004
Medical Device

Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for Industry

January 14, 2005
Software

Information for Healthcare Organizations about FDA’s “Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software”

February 9, 2005
Regulatory Submissions

Pharmacogenomic Data Submissions: Guidance for Industry

March 1, 2005

Other Resources

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