US FDA's ongoing compliance and enforcement outreach to industry – including holding regulatory meetings with and/or sending untitled letters to troublesome manufacturers – appears to be a contributing factor for why the agency sent an historically low number of quality-related warning letters to device-makers last year.
But officials in FDA's Center for Devices and Radiological Health stressed in an interview with Medtech Insight that there's no specific reason that a mere 35 warning letters were issued...
The agency's tabulation of 35 warning letters last calendar year – the lowest number recorded since the Quality System Regulation came into force in 1996 – tracks closely with its...
