North America


GAO Flags Technical Challenges for Disease Diagnostic Devices

Government Accountability Office researchers visited eight devicemakers in connection with a new report on diagnostic medical devices and found that the regulatory review process poses an obstacle to applying the technology in the marketplace. Read More

J&J Hit With $57 Million Judgment in Pelvic Mesh Case

A jury in Philadelphia awarded a $57.1 million judgment to a woman who claimed she has suffered years of pain from the failure of Johnson & Johnson pelvic mesh implants. Read More

Early Ergonomics Studies Can Help Combination Product Development

Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co. Read More

Judge Dismisses Whistleblower Lawsuit Against Boston Scientific

A federal judge granted Boston Scientific’s motion to dismiss a 2011 lawsuit alleging False Claims Act violations related to the sale of certain models of its Cognis and Teligen defibrillators. 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

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apply to the FDA for the first-ever marketing authorization of their products as medical devices, the agency says in draft guidance.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

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 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as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA says in new draft guidance. Read More

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

483 Roundup: FDA Cites Four Firms Over Complaints, CAPAs

The FDA issued Form 483s to four device manufacturers for issues ranging from responses to customer complaints to record-keeping. Read More