Unique Device Identifier Requirements for Combination Products
Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products…
Category: US National Health Agency Sources
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends …
Conducting Remote Regulatory Assessments Questions and Answers
Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry
mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following …
Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
Shang Hao Jia, Inc. of South El Monte, CA is recalling 50 case of Danshi brand Spicy Shredded Tofu, because it may contains undeclared sesame.
Mellace Family Brands California, Inc. Issues An Allergy Alert On Undeclared Milk Allergen In Wegmans Semi-Sweet Chocolate Nonpareils
Mellace Family Brands California, Inc. of Warren, OH is recalling Wegmans Semi – Sweet Chocolate Nonpareils, because they contain undeclared milk al…
ELEVIDYS
Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
Kilwins Quality Confections, LLC. Issues Allergy Alert on Undeclared Pecans in Mocha Truffles
Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans.