The U.S. Food and Drug Administration (FDA) recently proposed a new way to fast-track medical devices to the market. Scott Gottlieb, Commissioner of the FDA, proposed making a quicker route to market for certain products that might not meet the current criteria for clearance under the agency’s 510(k) fast-track pathway. Gottlieb’s reasoning for the proposal is that it would foster innovation.
This new proposal is part of on-going effort made by the FDA to limit the amount of clinical evidence required to approve medical devices. If the proposal ends up being implemented, it will save medical device companies millions of dollars each year and will significantly lower development times. However, it will also eliminate the need to test new products against existing products already on the market.
Currently, products approved under the 510(k) pathway must show substantial equivalence in the materials and intended uses when compared to an already existing and legally marketed device. This is known as predicate. This is the most common route for a medical device to make it to market, with about 3,000 devices being cleared this way every year. The new FDA proposal would instead use a set of technical standards that would essentially serve as a proxy for the predicate.
However, legal experts say that agency might have exceeded its authority. According to Donald Migliori, a lawyer with Motley Rice LLC who represents victims of defective medical devices and drugs, the agency seems to be “regulating the law away by providing an alternative path for companies that may be far more attractive for them.” To justify the proposal, the FDA will need get legally creative with its wording.
Do you have more questions about medical device regulations? Have you or a loved been injured by a medical device? Contact our Denver team of defective medical device injury attorneys to set up a free consultation today.