Tag: medical devices

FDA Posted Guidance Documents

New FDA Posted Guidance Documents 1/6/2021 – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff 1/6/2021 – Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff 1/5/2021 – Mouse Embryo Assay for Assisted Reproduction Technology Devices 1/5/2021 – Human Gene […]

FDA Final Guidance: Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) issued final guidance outlining the Safer Technologies Program (STeP) for Medical Devices. This program will be a voluntary pathway for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious […]

FDA OMHHE releases new video on medical device clinical trials

FDA’s Office of Minority Health and Health Equity released a new video about the importance of diverse participation in clinical research for medical devices. The FDA not only reviews new drugs, but the agency also reviews many medical devices before they are marketed to determine if they meet FDA’s safety and effectiveness standards. Diverse participation in clinical […]

FDA Medical Device Webinars for October 2019

The FDA’s Center for Devices and Radiological Health (CDRH) hosts webinars to help educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered. Webinars scheduled for […]

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