Currently, most new product introductions in the Medical Device industry follow the 510(k) pathway to gain approval. Under 510(k) companies must prove that the new device is a close equivalent to a previously approved, legally marketed device.
Unlike the approval process for drugs, the FDA method of device regulation as designed by Congress realizes that devices have different risk levels and that documentation requirements should correspond to degree of risk.
Some members of the medical device industry feel that the FDA has moved away from the original idea and is attempting to apply a standardized, drug-like approach to medical device regulation making it difficult to have new products approved. Furthermore, the FDA is viewing more low-risk devices through a high-risk lens.
Although 99.8% of medical devices have no significant adverse incidents in their history, there have been recent problems with hip replacements, bloodstream filters, morcellators and defibrillator wires.
In an effort to enhance safety, the FDA is setting up a unique device identifier (UDI) system to improve device performance tracking after approval and to upgrade recall effectiveness. The FDA aims to streamline evaluation when devices are in use which in turn will encourage future innovation.
However, the FDA also believes that success of the UDI system will only occur with full integration into the health care network. This requires a readiness by all players in the system including insurance companies, hospitals, doctor offices, patient registries to incorporate UDI into their electronic systems.
To illustrate how the UDI system functions, consider patient John’s experience after a knee replacement. In this case, the surgical team scans John’s knee implant UDI electronically adding it in his clinical record. John can also opt to register the UDI into his personal health record available through his provider and accessible using mobile apps.
Having a UDI record enables John to connect safety alerts with his implant in addition to communicating an adverse event to the provider, the manufacturer or the FDA. John’s ability to identify recalled devices eliminates unnecessary anxiety or facilitates corrective reaction.
John’s UDI inclusion into a national joint replacement registry and that collection of data will sustain further innovation in joint replacement. Moreover, this UDI data has the potential to reduce or eliminate long-term, post-market performance studies and data collection by the manufacturer
Whether this scenario plays out and leads to better care and transparency depends on the acceptance and adoption of all stakeholders in the medical device industry.
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