Warning Letter Close-Outs – September 2021
The US FDA issued one device-related close-out letter in September.
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The five products include a conditioning tool for eating disorders, a system that evaluates the properties of esophogeal tissue, and a tool used to measure the strain on an orthopedic implant during surgery.
Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.
The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.