Presenters: Fredrikson & Byron Attorneys Robert J. Klepinski and Briar A. Andresen
FDA Enforcement Activity: Hospital reporting of medical device events now resulting in Warning Letters
Medical device reporting for provider facilities has been in place for over a decade but has never been enforced by the FDA. In fact, the FDA originally was against such user reporting. Recent warning letters indicate a new FDA policy of enforcing user reporting. Provider facilities must prepare their procedures and practices in order to comply in this new environment.
