The FDA's 510(k) pathway enables timely market access to medical devices through substantial equivalence to a predicate device. While this supports innovation, it raises important questions about how new devices maintain or improve upon existing standards of care.
 
In practice, substantial equivalence does not ensure alignment of a new 510(k) device with existing clinical standards. As a result, manufacturers and clinicians may struggle to understand how new devices may change established standards of care.
 
This presentation proposes two voluntary practices to strengthen safety and transparency.
 
First, manufacturers should objectively assess whether a device introduces meaningful changes to an existing clinical standard of care. When such changes are identified, the determination should be adjudicated by a panel of non-conflicted experts or by expert consensus. In those cases, companies should voluntarily pursue an Investigational Device Exemption (IDE) to determine non-inferiority, or implement active post-market surveillance. This approach would prevent the 510(k) process from eroding existing clinical standards of care.
 
Second, U.S. manufacturers should take a binary approach to disclosing high-severity residual risks. Because ISO 14971 and its guidance (ISO/TR 24971) provide flexibility in defining “significant” risks, known but low-probability risks classified as Catastrophic/Critical (e.g., death or permanent impairment) are not always consistently communicated in labeling by some manufacturers. Full transparency in disclosing such known but low-probability/high-severity risks will support informed clinical decision-making, strengthen patient safety, and align risk management with the disclosure requirements of tort law - thus protecting patient safety and reducing product liability.
 
By adopting these steps, MedTech firms can establish a strong culture of safety for 510(k) medical devices.