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Oct 08 2019

New FDA Guidances for September 2019

Special Interest Guidances/Information Date Posted
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Final Guidance 27 Sep 2019
Clinical Decision Support Software – Draft Guidance 27 Sep 2019
General Wellness: Policy for Low Risk Devices – Final Guidance 27 Sep 2019
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Final Guidance 27 Sep 2019
Off-The-Shelf Software Use in Medical Devices – Final Guidance 27 Sep 2019
Policy for Device Software Functions and Mobile Medical Applications – Final Guidance 27 Sep 2019
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 26 Sep 2019
Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations – Draft Guidance 24 Sep 2019
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment – Final Guidance 23 Sep 2019
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Draft Guidance 23 Sep 2019
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy – Final Guidance 23 Sep 2019
Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products – Draft Guidance 20 Sep 2019
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Safety and Performance Based Pathway – Final Guidance 20 Sep 2019
Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Safer Technologies Program for Medical Devices – Draft Guidance 19 Sep 2019
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act – Final Guidance 18 Sep 2019
Format for Traditional and Abbreviated 510(k)s – Final Guidance 13 Sep 2019
Refuse to Accept Policy for 510(k)s – Final Guidance 13 Sep 2019
The Abbreviated 510(k) Program – Final Guidance 13 Sep 2019
The Special 510(k) Program – Final Guidance 13 Sep 2019
Acceptance Review for De Novo Classification Requests – Final Guidance 09 Sep 2019
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals – Final Guidance 09 Sep 2019
User Fees and Refunds for De Novo Classification Requests – Final Guidance 09 Sep 2019
Humanitarian Device Exemption (HDE) Program – Final Guidance 06 Sep 2019
Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older – Final Guidance 05 Sep 2019
Humanitarian Use Device (HUD) Designations – Final Guidance 05 Sep 2019
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers – Final Guidance 04 Sep 2019
Upcoming Meetings (* = New)
  October 9, 2019: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
  October 16, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement
* October 29, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
  October 30, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
  November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
  November 8, 2019: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
* November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* November 14, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Last updated: 04 October 2019