Month: April 2020

FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway The U.S. Food and Drug Administration today announced that, as a first step toward implementation of the recently established Safety and […]

FDA Enforces Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

U.S. Agents Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is […]

Serological Test Validation and Education Efforts Serological Test Validation and Education Efforts

Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

Device Registration and Listing Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807). […]

FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

Registration and Listing How to register facilities and products, and how to update registrations Animal and Veterinary Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of […]

510(k) Submission Process Introduction Premarket Notification (510(k)) submissions for medical devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, by the Office of Product Evaluation and Quality (OPEQ).  There are 7 device types and medical specialty offices within OPEQ. The Offices of Health Technology (OHTs) are organized according to medical device […]