CDER’s Work to Meet User Fee Goals During the Pandemic website includes an overview of the agency’s thinking regarding manufacturing facility inspections during the age of COVID-19. As always, the FDA will use a risk-based approach to identify facilities that require pre-approval inspection for submitted applications. The continued routine compliance inspections of domestic and foreign manufacturing facilities are affected by the travel, social distancing and other restraints which have become our new normal during the pandemic. As a result, the agency has been increasingly relying on alternative approaches to complete facility assessments. EAS has seen an uptick in requests for records from our clients. Contact us for information on EAS’s virtual assessment of your existing GMP management system.
The FDA has issued Import Alert 62-08, “Detention without physical examination of alcohol-based hand sanitizers manufactured in Mexico”. The agency obtained samples from 53 manufacturing facilities located in Mexico, and found a large number (94; 84% of those tested) either showed the presence of methanol and / or 1-propanol at unacceptable levels, or found the products to be subpotent. This violation of cGMP standards presents a serious safety concern to the public. Firms can contact the FDA to be removed from this Import Alert. Instructions to do so are found in the FR notice. Please contact EAS if you would like support through this process.
The FDA has determined the following 7 type I medical devices no longer require a premarket notification to ensure reasonable assurance of safety and effectiveness to end users. Exemption from the 510(k) requirement will be immediately in effect upon publication of the Federal Register notice in Federal Register Vol. 86, No. 10.
- Powder-Free Polychloroprene Patient Examination Glove (OPC)
- Patient Examination Glove, Specialty (LZC)
- Radiation Attenuating Medical Glove (OPH)
- Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves (OPA)
- Powder-Free Guayle Rubber Examination Glove (OIG)
- Latex Patient Examination glove (LYY)
- Vinyl Patient Examination Glove (LYZ)
This FR notice also announces the agency’s proposal to exempt an additional 83 class II devices and 1 unclassified device from the 510(k) requirement. Instructions on how to comment on this proposal can be found in the federal register notice. Comments and responses must be submitted within 60 days of the FR publication.
The FDA will periodically publish a consolidated Notice of Availability announcing all COVID-19 related guidance documents. The most up to date announcement can be found on FDA’s COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders webpage. Currently that is FR Vol. 86, No. 32 published 19 February 2021.
REdI Conference Drug Master File (DMF) and Drug Substance Workshop will be held virtually March 3-4, 2021. See the FDA webpage for registration information.
Recently published Guidance Documents
CDER
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency [Link No Longer Available]
Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
CBER
Investigational COVID-19 Convalescent Plasma
On August 23, 2020, FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA has subsequently reissued this EUA with revisions. FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.
FDA websites of interest
FDA Adverse Event Reporting System (FAERS) Electronic Submissions
COVID-19 specific FDA webpages
Personal Protective Equipment EUAs
Hand Sanitizers / COVID-19 webpage update
FDA updates on hand sanitizers consumers should not use
Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
Posted in Drug and Device Corner, Drugs, Medical Devices.