On December 20, 2016, the Food and Drug Administration (FDA) published regulations (Final Rule) establishing postmarketing safety requirements for combination products, which are products comprised of:

(1) a drug and a device;

(2) a device and a biological product;

(3) a biological product and a drug; or

(4) a drug, a device, and a biological product.

“Postmarketing safety” involves manufacturing events, device malfunctions, and events causing injury to users, and the reporting requirements relating to product and patient safety arising from these events. 
Continue Reading FDA Final Rule on Postmarketing Safety Reporting for Combination Products