Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
Category: US National Health Agency Sources
Antimicrobial Resistance
Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, com…
Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics
MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent an…
Guidance and Other Information of Special Interest to MCM Stakeholders
Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, rad…
Cleared 510(k) Submissions with Supporting Documents
Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.
Banco Vida Corp. – 606288 – 08/12/2020
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Vibrant Health Care, Inc. – 608426 – 11/18/2020
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Davati Medical Supply LLC – 615530 – 06/25/2021
Unapproved and Misbranded Product Related to Influenza Virus
Utah Cord Bank LLC – 614021 – 05/11/2021
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Davati Medical Supply LLC – 615530 – 10/14/2021
Unapproved and Misbranded Product Related to Influenza Virus