It’s all about risk definition for device recalls
A recent article in The Archives of Internal Medicine entitled Medical Device Recalls and the FDA Approval Process, reviews and challenges the apparent lack of device class designation linkage to recall risk.
http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30
Classification of a new device is based on risk and novelty. Classification of recall is based on risk to the patient. The study concludes that most of class I recalls, or high risk of death or serious health problems, are associated with class II devices. The article then concludes that these class II devices need more regulatory oversight.
Part of the problem is the assumption that class definition for devices are boxes and not linear gradients. I like to draw the analogy to skiing. A blue square slope can actually be light blue or very dark blue. The same holds for devices. Some class II devices do require clinical data. Trying to push the class II devices into PMA requirements increases regulatory burden, not to mention the increased difficulty in obtaining funding for these types of technology. Both result in a lack of treatment options for patients and their Physicians. Overall, there will always be more regulatory recalls for class II devices as there are more class II devices on the market. Also, some relatively simple, or low risk devices are used for life saving indications. Wouldn’t improvement in error reduction be a better approach? This involves FDA oversight of class II devices, which is already in place. Working within the system seems a simpler approach than change in regulations.