Nonin TruO2 OTC Faq

TruO2 OTC FAQ
Why is the FDA clearance process important?
The FDA clearance process is critical for several reasons, primarily centered on
ensuring public health and safety. Overall, the FDA clearance process is essential
for maintaining high standards in the medical device industry, ensuring that devices
are safe and effective for public use.
• Public Safety: The FDA regulates medical devices to allow the public to benefit from access to safe and
effective medical devices. This includes evaluating the potential risks and benefits of the device.
• Effectiveness: The FDA requires that medical devices perform as intended and provide the claimed
benefits. This helps prevent ineffective, misleading, or harmful devices from reaching the market.
• Rigorous Testing: The clearance process involves thorough scientific and clinical evaluations, including
clinical evidence, bench testing, and biocompatibility testing, to verify the safety and efficacy of the
device.
• Trust: FDA clearance instills confidence in consumers, healthcare providers, and insurers that the risks
and benefits of the device have been evaluated for the public benefit.
• Regulatory Compliance: Manufacturers must adhere to legal and regulatory requirements, ensuring
that devices are marketed responsibly and ethically.
• Preventing Harm: The FDA provides oversight to prevent harmful or fraudulent devices from entering
the market, protecting public health and reducing the incidence of device-related injuries or deaths.
• International Recognition: FDA clearance often serves as a benchmark for other regulatory agencies
across the globe. This facilitates international trade and the global distribution of medical devices.
What is required for a med device to obtain OTC clearance?
• Obtaining U.S. over-the-counter (OTC) clearance for a medical device involves several steps and
requirements set by the US FDA.
• Some of the steps include the following: device classification, pre-submission and regulatory pathway,
product development, testing and validation, labeling and instructions for use, quality management
system, 510(k) submission, FDA review and clearance, post-market surveillance, marketing and
distribution.
How are Health & Wellness medical devices different than a device that has
OTC clearance by the FDA?
• Health & wellness devices are not regulated by the FDA. They focus on general well-being only. OTC
medical devices undergo a rigorous FDA clearance process to demonstrate that they are safe and
effective for specific medical uses. This difference impacts how these devices are marketed, sold, and
monitored in the market.
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