As with any regulatory submission, there are inherent risks associated with the submission and approval process if required data are incomplete or missing. In addition, compliance activities can play a major role in risks following approval and with commercialization of products.
Some of the risks specific to 510(k)‑cleared devices include:
- Submission Rejection/Approvals: FDA 510(k) submissions can be rejected if they do not meet submission content requirements or they can encounter delays in approval if they do not meet required performance standards. This can result in additional development expenses, resource inefficiencies, and delays in market introduction.
- Regulatory Compliance Issues: Failure to comply with FDA regulations can lead to costly penalties, legal action, product recalls, or even product seizures.
- Inadequate Testing: Incomplete or inadequate testing of devices can increase the risk of product failures, adverse reactions, and patient harm.
- Adverse Events: Despite rigorous testing and regulatory oversight, FDA 510(k) devices can still be the subject of adverse events, including injury or death in patients. Proper monitoring and reporting of adverse events is required to ensure prompt mitigation as necessary.
