This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent parts, and outline requirements and…

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…

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

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. of Warren, OH is recalling Wegmans Semi – Sweet Chocolate Nonpareils, because they contain undeclared milk allergen. People who have an allergy or severe sensitivity to…

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., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans.

Labeling for CBER-Regulated Products