The Food and Drug Administration (FDA) is providing manufacturers with information to help them win faster approval for medical devices deemed “substantially equivalent” to other devices, even if the technology of the new device is different or carries different risks. The guidance is designed to prevent defective medical devices from passing through the agency’s abbreviated 510(k) approval process, which allows faster clearance to moderate risk devices if they are similar to other devices currently on the market.
The FDA has been revamping the 510(k) process since it was revealed four years ago that the faulty Johnson & Johnson DePuy ASR metal-on-metal hip replacement system had been granted approval under the accelerated approval process. The all-metal devices were deemed similar to traditional hip implants, which are made with plastic or ceramic parts.
However, the DePuy artificial hip was recalled in 2010 after it was found to fail at a faster than expected rate. The issue focused a spotlight on all so-called metal-on-metal hip replacement systems, which in many cases were corroding inside the body, infecting patients’ blood with heavy metals.
The new guidance outlines high-level policies but also gives several hypothetical examples to show how device makers can use new technology without going through the same drawn-out approval process that truly distinctive devices must undergo.
The FDA says it is willing to accept some disparities in risks and benefits with medical devices that are similar to currently marketed devices but have different technological characteristics. Likewise, the agency is willing to consider allowing a lower burden of proof on new technologies that could be important to public health.
The draft guidance also provides more details about how the agency will weigh risks and benefits, with overall risk being determined by the frequency, severity and duration of side effects.