FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates” and Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved? If you have questions regarding confirming your company’s establishment registration or product listings, EAS can assist as your FDA regulatory support. The FDA also highlighted their webpage regarding the FDA Logo Policy.
Recently published Guidance Documents
Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency
FDA is issuing this guidance to provide recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2, including addressing the impact of emerging variants, during the COVID-19 public health emergency.
CDER & CBER
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
FDA is issuing this guidance to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. Preventative vaccines and convalescent plasma are not within the scope of this guidance.
This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act.
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers
This guidance conveys recommendations to holders of approved new drug applications, biologics license applications, and abbreviated new drug applications regarding the reporting and implementation of some common changes to container closure system components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally.
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
FDA is issuing this guidance to provide a policy and recommendations on evaluating the potential impact of emerging and future viral mutations of SARS-CoV-2 on COVID-19 tests for the duration of the COVID-19 public health emergency. This guidance describes a policy for test developers to consider the impact of emerging and future variants on their COVID-19 tests during development and post-authorization.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act(42 U.S.C. 247d(a)(2)).
Emergency Use Authorization for Vaccines to Prevent COVID-19
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
Federal Register notices of interest
Federal Register Vol 86, No. 34 announces final guidance for industry Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) published in January 2021. The guidance is immediately in effect but remains open to comments.
Federal Register Vol 86, No. 42 includes information on the FDA’s implementation of support for Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model. The FR notice also includes required compliance dates for such.
Federal Register Vol 86, No 40 Modifications to the List of Recognized Standards, Recognition List Number 054.
Federal Register Vol. 86, No. 49 Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability; Reopening of the Comment Period
FDA websites of interest
CDRH Biocompatibility Assessment Resource Center
COVID-19 specific FDA webpages
Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
Personal Protective Equipment EUAs
Face Masks, Including Surgical Masks, and Respirators for COVID-19
Hand Sanitizers / COVID-19 webpage update
FDA updates on hand sanitizers consumers should not use
Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2
Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
News You Can Use
Getting Your Device into the U.S. Market
A Complimentary EAS White Paper
Getting a device ready for Premarket Notification 510(k) clearance submission is time-consuming, costly and full of challenges. EAS Independent Consultant Joseph Ouellette lays out the requirements for class II and III 510(k) submissions and offers guidance for doing so in an expeditious and accurate manner. Download the EAS White Paper on Getting Your Device into the U.S. Market. Learn practical tips for development of a regulatory plan, creating a list of deliverables as well as anticipating questions FDA may ask throughout the process.
Medical Device or Wearable Device
April 2, 2021
Presented by Jay Mansour, EAS Independent Consultant
A Look at Medical Device Manufacturing FDA Enforcement Actions
Presented by George Calafactor, Ph.D., EAS Independent Consultant
Posted in Drug and Device Corner, Drugs, Medical Devices.