August 18, 2020 Some contain flimsy surgical masks or cloth face coverings that are explicitly not intended for medical use. Others are missing items or have far less than the full weeks’ worth of protective equipment the government promised to send. Instead of proper medical gowns, many packages hold large blue plastic ponchos. “It’s like … Read more
August 11, 2020 The move is similar to a previous Agency authorization issued in late March that broadly covered ventilators and respiratory devices, in a bid to quickly expand their supply against the pandemic. That policy allowed alternative or modified devices to be used for ventilation, such as anesthesia gas machines, as long as they … Read more
August 06, 2020 But instead of testing one product, the Fitbit Heart Study plans to use several — including all of its current exercise trackers and smartwatches that can measure heart rate — to potentially enroll hundreds of thousands of people. The trial’s results will serve as the foundation for the company’s regulatory submissions to … Read more
August 04, 2020 Pfizer also announced at the end of July that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participants and expect a readout from their studies as early as this fall. Hahn’s remarks come as some observers … Read more
July 30, 2020 The effort is a partnership of the Advanced Medical Technology Association (AdvaMed) and 13 of its member companies: Abbott Laboratories; Becton Dickinson; bioMérieux; Bio-Rad; Beckman Coulter; Cepheid; Hologic; Ortho Clinical Diagnostics; Qiagen, Roche Diagnostics; Sekisui Diagnostics; Siemens Healthineers; and Thermo Fisher Scientific. Already, the companies involved are shipping more than 800,000 tests … Read more
July 24, 2020 User fee goals, policy review Despite an “incredible surge in volume” of applications and constraints on the Agency’s ability to conduct inspections, Hahn said that FDA, “has maintained the same pace of meeting its goals on applications for medical products for the last six months that is has maintained in recent years.” … Read more
July 21, 2020 Known as Multisystem Inflammatory Syndrome in Children (MIS-C), this condition is characterized by airway inflammation, rapid development of pulmonary edema, coronary artery aneurysms, and extensive intra-abdominal inflammatory changes. A team of investigators from Evelina London Children’s Hospital in London assessed these findings in children admitted to the hospital and published their findings … Read more
July 16, 2020 Brief: The final guidance issued in March hews closely to the partly disputed draft, with the most common change being the adoption of 3P510k, rather than 3P, as the abbreviation for the program. FDA did acquiesce to the pushback in some areas, for example by clarifying that review organizations should do assessments … Read more
July 14, 2020 The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last year. The Commission also released guidelines on in May explaining the process and … Read more
July 10, 2020 The hand-held product, which is around the size of a mobile phone, is part of a new class of antigen testing technology that promises to bring faster, cheaper testing to doctors’ offices, urgent-care centers and other medical facilities. The first such test, from Quidel Corp., was cleared for U.S. use in May. … Read more