FDA to Launch PMA Pilot Program This Month
The FDA is preparing its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ controls for… Read More
FDA Guidance Aims to Improve Demographic Data for Devices
The FDA released guidance to help the medical device industry analyze and report clinical study data on age, racial and ethnic subgroups, noting there is… Read More
Devices News
FDA Recommends Risk-Based Animal Testing of Organ Preservation Devices
Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA ... Read More
App for Substance Abuse Treatment Wins FDA Marketing Clearance
The FDA approved marketing of a prescription smartphone app to help patients with substance abuse issues. The app, reSET, from Pear Therapeutics, is the first approved mobile medical application for treatment of substance use disorder. Read More
FDA Spells Out Which Microneedlers Are Medical Devices
Manufacturers of microneedling instruments that go beyond removal of dead skin cells should apply to the FDA for the first-ever marketing authorization of their products as medical devices, the agency says in draft guidance. Read More
FDA Officials Show Support for Risk-Based CAPA Strategy
FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Read More