News

FDA NEWS  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 510(k) Premarket Notification – FDA  https://www.drugwatch.com/fda/510k-clearance/ FDA 510(k) Clearance – Dangerous Fast-Track Approval Process  https://www.greenlight.guru/glossary/510k-pma 510k vs PMA | Greenlight Guru  https://www.fda.gov/training-and-continuing-education/cdrh-learn/510k-program-transcript The 510(k) Program – Transcript | FDA  https://www.adctoday.com/faq/some-medical-devices-have-510k-number-what-and-do-adc-devices-have-510k-number Some medical devices have a 510(k) number. What is this and do …  https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances 510(k) Clearances | FDA  https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k Premarket Notification 510(k) | […]

In Vitro Diagnostics EUA In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person’s […]

Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system The U.S. Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March. The White House Guidelines […]

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents As a result of the Coronavirus Disease 2019 (COVID-19) pandemic and under the authority of section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA has issued numerous Emergency Use Authorizations (EUAs) for medical devices intended to […]

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to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway The U.S. Food and Drug Administration today announced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). […]