Device Center To Add Program For Joint Planning Of PMA Submissions
This article was originally published in The Gray Sheet
Executive Summary
The Center for Devices and Radiological Health is planning to offer a new type of meeting in which sponsors and FDA reviewers agree on content and format of a premarket application submission
You may also be interested in...
CMS Coverage Policy, IT Programs Foster Information Transfer – Tunis
CMS input during a company's clinical research design process could set the stage for more effective information transfer as the technology moves past the regulatory process into clinical practice, CMS Acting Chief Medical Officer Sean Tunis suggested at an "evidence-based innovations" healthcare conference Jan. 27 in Washington, D.C
CMS Coverage Policy, IT Programs Foster Information Transfer – Tunis
CMS input during a company's clinical research design process could set the stage for more effective information transfer as the technology moves past the regulatory process into clinical practice, CMS Acting Chief Medical Officer Sean Tunis suggested at an "evidence-based innovations" healthcare conference Jan. 27 in Washington, D.C
Earlier OST Involvement In Device Lifecycle Is Potential User Fee Impact
Medical device user fees could spur the Office of Science & Technology to become involved with reviews earlier in the device lifecycle, CDRH topsiders suggest