Regulatory Affairs

CDRH Finalizes Guidances on 510(k) Submissions

The best way to improve innovation and safety in the 510(k) program “is to drive innovators toward reliance on more modern predicate devices or objective performance criteria,” said CDRH Director Jeffrey Shuren. 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