RAPS Florida Chapter: Keys to Planning and Handling a Medical Device Recall

The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Product liability and financial risks are staggering when companies fail to properly report and take action when required. Firms need to voluntarily remove their regulated product that is either defective or potentially harmful by recalling that product and implement a compliant and effective recall program. This program should include removing it from the market or correcting the problem, which is the most effective means for protecting the public.  A properly handled recall program can minimize the risk of major FDA enforcement activities and minimize further expensive product liability risks.

Join colleagues from your local regulatory community to hear an interactive presentation from former CDRH recall branch chief, Rita Hoffman, RAC. The presentation will provide an overview of FDA's expectations for companies conducting recalls, the regulations that apply and provide guidance for if, when, and how a firm should prepare for and conduct a device recall.

 Continental breakfast will be available. RAC holders can claim two RAC recertification credits.