- 9/27/2019 - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration Staff
- 9/27/2019 - Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff
- 9/27/2019 - General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff
- 9/27/2019 - Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff
- 9/27/2019 - Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- 9/27/2019 - Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff
- 9/26/2019 - Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry and Food and Drug Administration Staff
- 9/25/2019 - CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter
- 9/24/2019 - Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
- 9/23/2019 - Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry: Guidance for Industry
- 9/23/2019 - The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
- 9/23/2019 - Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry
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