Medical Device FDA Clearance vs Approval

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Published: 2026-10-04T23:15:31.745Z • Permanent link

Regulatory clarity was finally achieved for the medical device industry last month when the FDA issued a revised guidance on the difference between clearance and approval for medical devices. This long-awaited clarification was made possible by the concerted efforts of the FDA's device center, led by Commissioner Robert M. Califf, and the input of various industry stakeholders, including the National Institutes of Health (NIH) and the Medical Device Innovation Consortium (MDIC). The guidance, which took effect on March 16, 2023, aims to reduce confusion among manufacturers and healthcare professionals by providing a clear framework for distinguishing between clearance and approval for medical devices. Under the new guidance, the FDA will issue a clearance letter stating that a device has been deemed substantially equivalent to a predicate device, while an approval letter will confirm that a device has been deemed safe and effective for its intended use.

The revised guidance has significant implications for the medical device industry, particularly for companies that have been waiting for clarity on the regulatory status of their products. For example, the FDA has been reviewing the clearance status of the FDA-approved blood glucose monitoring system, the Dexcom G6, since 2015. While the device was initially cleared for use in 2012, the FDA has been scrutinizing the device's performance data and requesting additional information from the manufacturer. The new guidance provides a clear framework for resolving this uncertainty, allowing the FDA to issue a final clearance letter for the device.

The FDA's revised guidance also reflects the agency's commitment to promoting innovation in the medical device industry. The agency has recognized the importance of reducing regulatory barriers to entry for new technologies, and has taken steps to streamline the clearance process for innovative devices. For example, the FDA has established a new expedited review program for innovative devices that demonstrate significant improvements in patient outcomes. This program, known as the Fast Track Device Review Program, aims to accelerate the review process for devices that have the potential to improve patient care.

The FDA's revised guidance on clearance and approval has significant implications for the medical device industry, particularly for companies that rely on FDA clearance to bring their products to market. For example, companies like Medtronic and Stryker have been waiting for clarity on the regulatory status of their products, including the company's own medical devices. The new guidance provides a clear framework for resolving these uncertainties, allowing companies to plan and invest in the development of new products.

The FDA's revised guidance also has implications for research communities and markets. For example, the guidance provides a clear framework for researchers to design studies to demonstrate the safety and effectiveness of new medical devices. This will enable researchers to more effectively evaluate the performance of new devices, and will help to ensure that only safe and effective devices are approved for use in clinical practice. The FDA's revised guidance also reflects the agency's commitment to promoting innovation in the medical device industry, and will help to drive growth and investment in the sector.

The FDA's revised guidance on clearance and approval reflects a broader trend in regulatory policy, which is shifting towards a more risk-based approach to device regulation. This approach recognizes that the medical device industry is characterized by a high degree of complexity and variability, and that regulatory oversight should be tailored to the specific risks associated with each device. For example, the FDA has established a new regulatory framework for high-risk devices, such as implantable devices and in vitro diagnostic devices, which provides a more detailed and prescriptive approach to regulation. This framework, known as the Deeming Regulation, has been in place since 2015, and provides a clear framework for regulating these devices.