Time: 2024-08-24
Silver Spring , Maryland on August 23 , 2024 - On this day , the U.S. Food and Drug Administration ( FDA ) supply a summary of update within the agency . The FDA publish a small entity Compliance Guide ( SECG ) to aid small entity , include mammography facility , in adhere to the FDA 's March 2023 final rule , know as the " 2023 MQSA Rule " . These amendment , set to return consequence on September 10 , 2024 , purpose to enhance regulation by integration current scientific promotion and best practice in mammography standards.
Furthermore , the FDA update its advisory see a Salmonella outbreak associate with cucumber . In collaboration with the Centers for Disease Control and Prevention ( CDC ) , state , and local spouse , the agency investigate a multistate outbreak of Salmonella Africana and Salmonella Braenderup infection . The outbreak result in 551 illness across 34 state and the District of Columbia . While cucumber from Bedner Growers , Inc. , and Thomas Produce Company were identify as potential beginning , not all case could be impute to these agriculturist . The outbreak was officially declare over as of August 22 , 2024.
The FDA let_go_of a draft guidance on predetermine change control Plans for checkup devices on Wednesday . This guidance propose a policy for predetermine change control plan ( PCCPs ) and offer recommendation for include pertinent information in a selling submission for a device . The primary aim of review the PCCP is to guarantee ongoing safety and effectiveness of the device without necessitate extra submission or foster mandate for alteration . A webinar discourse the guidance is schedule for September 3 , 2024 , and remark can be submit until November 20 , 2024 , by reference docket number FDA-2024 - D-2338 on www.regulations.gov.
In addition , the FDA introduce a new support opportunity for the FDA Rare Neurodegenerative Disease Grant Program . This plan purpose to support clinical test measure the efficacy and safety of merchandise for rare neurodegenerative disease in both child and adult . Through collaborative and advanced clinical test , the FDA seek to expand the blessing of checkup merchandise for these conditions . The grant plan was establish under the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act ( ACT for ALS ) and is administer by the FDA 's Office of Orphan Products Development.
The FDA , a critical agency within the U.S. Department of Health and Human Services , play a crucial function in safeguard populace health by guarantee the safety , effectiveness , and security of assorted checkup merchandise . This include homo and veterinarian drug , vaccine , biological merchandise , checkup devices , food supply , cosmetic , dietary addendum , and tobacco merchandise . By continue rigorous regulative standard , the FDA continue its committedness to protect the well - being of person and community across the nation.
For medium inquiry , please contact the FDA Office of Media Affairs at 301 - 796 - 4540 . consumer inquiry can be direct to 888 - information - FDA.
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