As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance in manufacturing to the CDRH. The list of relevant devices can be found on this FDA website. A Guidance Document was implemented for the duration of the current health emergency. The agency has developed an online webform to submit these notifications. Also provided to assist manufacturers with this requirement is the Online 506J Notification Submission Methods: Frequently Asked Questions webpage.
Per the FDA’s OMUFA website
When will OMUFA fees be due for fiscal years after FY 2021?
For fiscal years after FY 2021, OMUFA facility fees will be due on the later of
(a) the first business day of June of each year OR
(b) the first business day after the enactment of an appropriations act providing for the collection and obligation of OMUFA fees for such year
The facility fee amounts will be set in advance of the due date through a Federal Register Notice, in accordance with the process specified under the statute.
[keep in mind, the fee is due 45 days after the Federal Register notification]
Recently published Guidance Documents of note:
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Q & A
FDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency.
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, effective January 27, 2020, including any renewals made by the HHS Secretary.
FDA is issuing this guidance to provide a policy to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including healthcare personnel, and surgical masks and particulate filtering facepiece respirators for HCP for the duration of the COVID-19 public health emergency.
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, effective January 27, 2020, including any renewals made by the HHS Secretary.
Recently published Guidance Documents can be searched on the FDA’s website.
Federal Register notices:
FR Vol 83, No. 117 Technical Specifications for Electronic Submissions; Establishment of a Public Docket
FDA websites of interest:
Novel Excipient Review Pilot Program
FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
The ABCs of Product-Specific Guidances
Tracking Your Premarket Submission’s Progress (Progress Tracker)
Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers
Upcoming FDA Meetings:
Enhanced Drug Distribution Security in 2023 Under the DSCSA webinar is scheduled for Tuesday 5 October 2021. Please follow the link for further details and registration.
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Workshop Wednesday, October 13, 8:45 am – 4:00 pm EDT
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World will be held Tuesday, October 26 and Wednesday, October 27 online. Please follow the link for further details and registration.
Posted in Drug and Device Corner, Drugs, Medical Devices.