FDA Roundup: August 23, 2024

SILVER SPRING, Md., Aug. 23, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA issued a Small Entity Compliance Guide (SECG) to assist small entities, including mammography facilities, in complying with the FDA’s March 2023 final rule (“2023 MQSA Rule”) amending regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act. The amendments, which become effective September 10, 2024, will help modernize the regulations by incorporating current science and mammography best practices.
On Thursday, the FDA updated the advisory for the investigation of the Salmonella outbreak linked to cucumbers. The FDA and CDC, in collaboration with state and local partners, investigated a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 551 illnesses in 34 states and the District of Columbia. Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, and Thomas Produce Company, of Boca Raton, Florida, are likely sources of illnesses in this outbreak; however, these growers do not account for all the illnesses in this outbreak. As reported by CDC, as of August 22, 2024, this outbreak is over.
On Wednesday, the FDA issued the draft guidance: Predetermined Change Control Plans for Medical Devices. This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. The FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing each modification described in the PCCP. The FDA will host a webinar on September 3, 2024 about the guidance. For comment submissions, please see the docket number FDA-2024-D-2338 at www.regulations.gov by November 20, 2024.
On Wednesday, the FDA updated the advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies, to include updated cases counts and additional sample results for Diamond Shruumz-brand chocolate bars. An updated list of store names and locations known to sell Diamond Shruumz-brand products is available.
On Wednesday, the FDA announced a new funding opportunity for the FDA Rare Neurodegenerative Disease Grant Program to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Through the support of collaborative, efficient and innovative clinical trials, the FDA hopes to exert a broad and positive impact by increasing the number of approved medical products for rare neurodegenerative diseases. The FDA Rare Neurodegenerative Disease Grant Program was established by the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS). This program is administered by the FDA’s Office of Orphan Products Development, and supports research on ALS as well as other rare neurodegenerative diseases.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.