Streamlining FDA Review: Strategic Solutions and Expert Insights
In 2023, the FDA faced a significant surge in Premarket Notifications, with over 4,000 submissions alone. As the demand for medical devices continues to grow, so does the pressure on the FDA to expedite review times and meet the Medical Device User Fee Amendments (MDUFA) performance goals. The Center for Devices and Radiological Health (CDRH) highlighted the success of the FDA’s Breakthrough Devices Program in its 2023 annual report. This program aims to "increase access to innovative, high-quality medical devices by expediting their development, assessment, and review, while ensuring these devices meet FDA’s statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization."
With the rise of complex medical devices incorporating advanced technologies like artificial intelligence (AI) and machine learning (ML), the size and complexity of submissions have increased, putting a strain on FDA resources. The Breakthrough Devices Program represents a proactive approach to address these challenges. However, there remains a question: how can the review of simpler, lower-risk devices be expedited?
The Third Party Review Program: An Alternative Pathway
Enter the FDA’s Third Party Review Program (formerly known as the ‘Accredited Persons Program’), which has been in place since 1997 and was improved in 2017. Many manufacturers are unaware of this program, which was designed to expedite the review of eligible low to moderate-risk devices requiring premarket notification. By voluntarily submitting to an accredited third party rather than directly to the FDA, manufacturers can benefit from:
Although the list of eligible devices (product codes) is somewhat limited, it covers a broad range of categories, including anesthesiology, ear, nose & throat, hematology, obstetrics/gynecology, physical medicine, cardiovascular, gastroenterology, immunology, ophthalmic, radiology, clinical chemistry, general & plastic surgery, microbiology, orthopedic, toxicology, dental, general hospital, neurology, pathology, and molecular genetics.
Additionally, the FDA has introduced the voluntary Safer Technologies Program (SteP), a review pathway for devices and device-led combination products that do not qualify for either the Breakthrough Devices or Third Party Review programs but are expected to significantly enhance the safety of current treatments or diagnostics for less serious conditions.
With constantly advancing technologies and evolving review pathways, the regulatory landscape continues to shift. Unsure which pathway is right for your device? Kapstone is dedicated to helping clients identify and leverage the most suitable pathway for their specific device needs.
Maximize Your Pathway with Expert Guidance
Navigating the evolving regulatory landscape can be complex. Leveraging the expertise of a medical device consultant like Kapstone Medical can be invaluable in identifying and optimizing the right pathway for your device. A consultant provides not only deep industry knowledge but also practical insights into the regulatory process, helping you to streamline your submission and improve your chances of success.
Partnering with a consultant from the beginning ensures a thorough understanding of your device’s purpose, functionality, and regulatory requirements. This collaboration can facilitate a smoother journey through regulatory compliance and clearance activities, saving time and reducing potential roadblocks.