The Food and Drug Administration (FDA) has issued a draft guidance that clarifies how benefit-risk determinations are made and approval is granted during reviews of pivotal medical devices. The guidance focuses on pre-market approval applications (PMAs), the regulatory pathway for the highest-risk medical devices. These devices are ones that support or sustain life, and whose failure would therefore be life-threatening. Known as Class III medical devices, these products are subject to the most stringent form of FDA device review. These include pacemakers and automated external defibrillators (AEDs). Most Class I medical devices, or those that are non life-sustaining, are exempt ... Read More
Righting Injustice is published by the Beasley Allen Law Firm. If you are interested in a free legal consultation, please take a few moments to fill out the contact form with as many details as possible. The more information you provide us, the better we can evaluate your claim.