Many of the questions we receive from investors relate to the process for obtaining US Food and Drug Administration (FDA) approval for surgical devices, such as the Ocumetics Accommodating Lens. This month’s message is focused on outlining how the process works and unpacking the steps required to obtain FDA approval.
You will be thrilled to know that we are currently on the pathway to FDA approval, and are journeying forward to bring the Ocumetics Accommodating Lens technology to market.
The development and approval of surgical devices in the United States is a rigorous and highly regulated process overseen by the FDA. This process is designed to ensure that these devices are safe and effective for use in medical procedures, ultimately safeguarding patient health and well-being.
The process can be summarized as follows:
1. Preclinical Testing:
FDA approval begins with extensive preclinical testing. Manufacturers, such as Ocumetics, conduct laboratory and animal testing to assess the device’s safety, performance, and potential risks. This stage provides critical data to support the device’s safety and effectiveness.
We are pleased to report that Ocumetics has substantially completed this step and expects to receive its final animal study report prior to the end of 2023.
2. Investigational Device Exemption (IDE):
If the preclinical testing yields positive results, the manufacturer may submit an IDE application to the FDA. This application outlines the proposed clinical trials and provides a comprehensive overview of the device’s design and intended use. Once granted, an IDE allows the manufacturer to conduct clinical trials on human subjects.
Ocumetics is currently preparing this paperwork and we expect to submit it prior to the end of 2023.
3. Clinical Trials:
Clinical trials are pivotal in the FDA approval process. Manufacturers must conduct well-designed trials, collecting data on the device’s safety and efficacy while closely monitoring patient outcomes. These trials typically progress through multiple phases, involving an increasing number of participants.
We are also pleased to report that Ocumetics expects to commence the clinical trial process with a first-in-human study in the Dominican Republic. Although the commencement date is not yet confirmed, we are on track to begin in Q1 2024.
4. Premarket Approval (PMA) or 510(k) Submission:
After successful clinical trials, the manufacturer can choose between two pathways for FDA approval. A PMA application is required for devices with no equivalent on the market and is typically more comprehensive, including all trial data and manufacturing information. Alternatively, a 510(k) submission can be made if the device is deemed substantially equivalent to an existing FDA-cleared device. The FDA reviews these submissions to ensure they meet safety and efficacy standards.
Our current belief is that due to the significant innovation incorporated within the Ocumetics Accommodating Lens technology, there are no equivalent products with FDA clearance, and Ocumetics will follow the PMA application route.
5. FDA Review:
The FDA’s review process is meticulous. For PMA applications, it involves a panel of experts who thoroughly examine the clinical data, device design, labeling, and manufacturing processes. 510(k) submissions undergo a similar but slightly less intensive review.
6. FDA Decision:
Upon completion of the review, the FDA will either grant an FDA approval letter or issue a request for additional information. Approval signifies that the device meets the FDA’s stringent safety and effectiveness standards, and the manufacturer may commence commercialization activity in the USA.
7. Post-Market Surveillance:
Even after approval, surgical devices remain under scrutiny. Manufacturers must report any adverse events and continuously monitor the device’s performance in real-world settings. This ongoing surveillance ensures that any issues are promptly addressed.
The FDA’s approval process for surgical devices is a comprehensive and systematic journey that prioritizes patient safety. Manufacturers must invest significant time and resources to navigate this process successfully, but the end result is worth it—a safe and effective surgical device that can improve patient outcomes and healthcare practices.
This is a high-level overview of the process. We are here to answer more detailed questions at any time. Please contact me at dean.burns@ocumetics.com with any questions.
