The Food and Drug Administration (FDA) has issued a draft guidance that clarifies how benefit-risk determinations are made and approval is granted during reviews of pivotal medical devices.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 from pre-market review in the United States. Class I devices include walking canes and cold packs.
Class II devices, also known as moderate-risk, generally go through the 510(k) procedure, an expedited process that grants approval for devices that are determined to be sufficiently similar to comparable products that have been previously cleared by the FDA. These include hip and knee implants.
The expedited approval process for these moderate-risk medical devices recently has come under review, with concerns that the process grants approval for medical devices before they have been thoroughly tested, which may put patients’ health at risk. One example is the DePuy hip replacement system, which was recalled last year after reports of early failures and injuries associated with the devices. The DePuy artificial hip was approved through the FDA’s 510(k) process.
The new draft guidance for Class III devices is intended to improve the predictability, consistency and transparency of the pre-market review process for applicable devices, and is designed to help manufacturers navigate the approval process more easily. This is the first time the federal agency has issued such guidelines.