Short Abstract

On August 15, 2011, the the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance on making benefit-risk determinations as a part of medical device pre-market decisions. The document describes for the first time the criteria CDRH uses to make such determinations to assure that CDRH and industry approach these decisions consistently using a commonly understood framework.

In addition, CDRH staff would be required to complete a template addressing each applicable criterion and including it in the administrative record for an IDE, PMA, or 510(k), if appropriate, thereby facilitating a dialogue both within the Center and between CDRH staff and sponsors on what matters most in making benefit-risk determinations. The criteria and template would also result in greater predictability and consistency in CDRH decision making.

Of note, the criteria take a patient-centric approach by calling for the consideration of patients’ tolerance for risk in applicable cases to assure that our decisions appropriately take into account the needs and desires of the ultimate beneficiary of the FDA pre-market program - patients. The FDA currently working with a large coalition of patient advocacy groups organized by the National Organization for Rare Disorders on establishing mechanisms for obtaining reliable information on patient perspectives.

This webinar will teach you:

• FDA Regulations for for REMS in the USA
• What you need to do before and after you file your application with the FDA ensure the success of your RMP and your MA application
• Designing and running a medical device post-marketing registry to describe product benefit:risk from a medical and patient perspective and satisfy FDA requirments