Purpose To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and ...
We monitor and report recall news daily and work to bring you quality, researched reporting on information that’s important to the general public. We’re committed to watching and reporting on: Real-time Trends in US Recalls Peer Reviewed Data Relevant News from Credible Sources Safety Related ...
FDA Reason for Device Modification by Supplement Type View LargeDownload Table 3. Top 5 FDA-Determined Root Causes of Recalla View LargeDownload Supplement. Data Sharing Statement 1. US Food and Drug Administration. Learn if a medical device has been cleared by FDA for marketing. Updated ...
FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device iota Biosciences, Inc., a wholly-owned subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that the U.S. Food and Drug ...
CLASS I RECALL There isan updateto the recent Salmonella outbreak linked to eggs being recalled in nine states, including Minnesota. The FDA says there is 'reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.' ...
FDA Will No Longer Allow Use of Red Dye No. 3 in Food, Drugs HealthDayJan. 15, 2025 What to Know About Raw Milk Unpasteurized raw milk may be championed by Robert F. Kennedy, Jr. and wellness influencers on TikTok, yet experts say raw milk is risky. ...
Objective: To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall. Design, Setting, and Participants: In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December...
Preparation of meat products and other foodstuffs:The U.S. Food and Drug Administration (FDA) regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Departm...
Each database entry was linked to a single FDA warning document and included the date, product name, company, hidden ingredient(s), lot, and product category (the indication for which the product was marketed). Warning document type (voluntary recall released by the responsible dietary supplement...
Design Descriptive study of the PASs ordered for medical devices using the FDA’s PASs website, the Premarket Approval database, and supplemental information provided by the FDA. Main Outcomes and Measures The proportion of medical devices that received a PAS order and study characteristics. Results...