The FDA has planned a public webinar titled Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency. Please follow the link to register for this webinar scheduled for 25 August 2021.
Recently published in the Federal Register, FDA has issued their final determination regarding Class I Surgeon’s and Patient Examination Gloves. This notice clarifies the confusion caused by two conflicting notices previously published in the Federal Register. Per this final determination, the subject seven types of Class I surgeon’s gloves and patient examination gloves are reserved class I devices, for which a premarket notification is required. Read the FR notice for full details.
On 30 June 2021, the FDA issued a letter to Health Care Personnel and Facilities revoking the Emergency Use Authorization (EUA) for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems. These devices are no longer authorized for use by health care personnel in health care settings. For any companies wishing to market approved respirators, EAS can assist with your 510(k) application.
Providing Regulatory Submissions in Alternate Electronic Format for submissions that are exempt or have a waiver from eCTD requirements, is a newly published guidance document intended to assist applicants with the FDA’s transition to fully electronic record keeping. Although the special publishing software needed to create eCTD xml files is not required, submissions should still follow the technical specifications described in The Comprehensive Table of Contents Headings and Hierarachy.
The FDA has issued the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) guidance document intended to assist labelers by clarifying the agency’s interpretation of certain requirements under 21 CFR 801.40. The document describes both forms the UDI must appear in on the label (human and machine readable). Additionally, it clarifies the content of the UDI, and the use of data delimiters. Please see the guidance document for further information.
DRAFT Guidance for Industry “Remanufacturing of Medical Devices” has been published by the agency with request for comment from industry and interested parties. The goal of this guidance when finalized, is to clearly articulate the distinction between ‘servicing’ and ‘remanufacturing’ when it comes to reusable medical devices. As proper servicing of these type of medical devices is critical for continued safe and effective use, the FDA would like to clarify when remanufacturing occurs so the regulatory responsibilities for parties are clear. The agency’s determination of whether an entity is a servicer / remanufacturer is based on specific activities such entity performs on a particular device. This draft guidance will focus on activities that are likely to be remanufacturing. Comments are due no later than 23 August 2021.
Non-FDA related, but still relevant for EAS clients, information can be found on the Federal Trade Commission (FTC) website regarding the FTC’s newly finalized rule governing ‘Made in the USA’ claims. Please follow the link for details on the anticipated heightened enforcement.
Recently published Guidance Documents of note
Field Alert Report Submission: Questions and Answers – This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy.
Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies – This guidance provides recommendations to help sponsors comply with the expedited safety reporting requirements for human drug and biological products that are being investigated (1) under an investigational new drug application (IND), or (2) as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements.
CVM GFI #261 – Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs – This guidance is intended for sponsors and potential sponsors interested in pursuing conditional approval of new animal drugs for certain major uses in major species.
Recently published Guidance Documents can be searched on the FDA’s website.
FDA Websites of Interest
- FDA Updates Recognized Consensus Standards Database with List 56
- Other OMUFA Fee-Related Questions website has Q & A for the program.
- Updated website for UDI Rule and Guidances, Training, Resources, and Dockets