Regulatory Affairs

IMDRF Flags Lack of ‘Global Alignment’ in Cybersecurity

Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity principles and practices.” Read More

FDA Creates New Safer Technologies Program

The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More

FDA Issues Warning to Indiana Devicemaker

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More