Changes to FDA approval process needed to improve safety of high-risk medical devices
Premarket approval, or PMA, is the process by which the FDA assesses the safety and effectiveness of new devices. When modifications to existing devices are made, a less rigorous process known as a PMA supplement is employed. This process does not require clinical data and researchers are concerned that clinicians and patients may be subjected to unknown risks, especially when devices have multiple PMAs.
The authors of a commentary being published in Annals of Internal Medicine cite two examples where devices that had undergone changes after the original approval had to be recalled after the devices failed or caused patient deaths.
They say changes in the process are required to ensure patient safety and that the FDA's Unique Device Identification program is not enough. With the understanding that device improvements require rapid approval, the authors say clinical data, even on a limited basis, must be included in PMA supplements that are not cosmetic or packaging changes. Clear labeling and publicly accessible data registries that record ongoing clinical outcomes and adverse events for all device recipients would also help clinicians make informed decisions about devices.