How Do You Recall Investigational Drug And Medical Device Products?
Recalling an investigational product is a little easier than recalling a marketed prescription drug or device. Marketed drug products and devices are on pharmacy shelves, in the doctors’ office or in the consumer’s home and that can make recovery difficult. This article will tell you how to recall investigational drug and medical device products when conducting clinical research. Develop and implement written procedures on product recall. Your procedure should clearly identify what circumstances could result in a recall. The procedure should also identify each person involved in the process and their responsibility to recover the product. All personnel involved with an investigational drug or device should be encouraged to contact management immediately if they notice serious or life-threatening problems with a drug or device. A written procedure with names and numbers and reporting process should be available to all employees, consultants, and vendors. Investigate and document the pro
