Gottlieb Announces Medical Device Approval Process Update

FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in order to accommodate rapidly advancing technologies. He described the modernization of FDA’s review framework would include the addition of a voluntary, alternative pathway for demonstrating substantial equivalence, and allow more flexibility to use modern criteria as the reference standard. Additionally, the new pathway will permit comparisons to standards that more closely approximate the kind of novel technology being evaluated. The new framework will be offered in addition to the current 510(k) pathway. Background As established in the Medical Devices Amendments of 1976, manufacturers of new, moderate-risk devices must demonstrate substantial equivalence to a similar device legally marketed in the U.S. in order for a new device to be cleared by the FDA. The older devices acting as a comparator are called the predicate devices. This process is often known as the 510(k) pathway. However, this framework has not changed significantly in 40 years. Because the predicate devices that new products must compare themselves to may be up to 40 years old, it creates a burden for 510(k) applicants as newer devices have more advanced technologies. This makes it difficult to identify suitable predicate devices in order to conduct testing. Modernizing 510(k) Review Gottlieb announced that FDA will be publishing a draft guidance outlining a voluntary, alterna...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs