The European Union’s Medical Device Coordination Group has posted a series of guidances addressing several matters, including regulatory requirements for ventilators and associated accessories. The scope of this guidance covers class IIa and IIb ventilators, and allows the manufacturer/marketing authorization holder to license the production of such articles to third parties for the duration of the COVID-19 pandemic. Also on the list of new publications is a guidance for clinical evidence needed for devices previously holding a CE mark, as well as guidances addressing clinical planning for and evaluation of follow-up of devices.
The U.K. National Institute for Health and Care Excellence said the Pneux device by Venner Medical Inc., of St. Helier, Jersey, shows promise as a treatment for ventilator-associated pneumonia, but that there is insufficient evidence to recommend adoption by the U.K.’s trusts. The evidence for clinical effectiveness is based on a study of the device’s use in high-risk patients undergoing cardiac surgery, and the device cost is pegged at £150 while projecting a savings of nearly £740 in the populations studied.
The U.S. FDA has postponed indefinitely the ophthalmic devices advisory committee hearing previously scheduled for June 9 for the PMA for the Visability Micro Insert by Refocus Group Inc. The agency will provide an update on another date for the hearing in the future.
The U.S. CDC will convene a May 15 meeting of the Healthcare Infection Control Practices Advisory Committee via teleconference. The agenda for the meeting includes a review of a report on COVID-19 transmission in long-term care facilities. The 90-minute meeting will commence at 3 p.m. Eastern.