TRI Partners with Sponsors for 510(k) Submissions

A 510(k) submission is a premarket submission made to the U.S. Food and Drug Administration (FDA) for the purpose of obtaining clearance to market a medical device or instrument in the United States. An in-vitro diagnostic (IVD) medical device manufacturer may need to submit a 510(k) application if it intends to introduce a new IVD medical device, modify an existing device, or introduce a device that is substantially equivalent to an existing one.

510(k) submissions are important because they:

• Ensure that medical devices are safe and effective
• Provide opportunities for innovation
• Promote competition among manufacturers
• Give patients and healthcare professionals confidence in the devices they use

The Complexities Associated With 510(k) Submissions

The complexities associated with 510(k) submissions are due to the need to understand the regulatory landscape, the diversity of comparative in vitro diagnostic devices currently available, and the data and testing requirements. Companies often find it necessary to work with regulatory experts, and invest considerable time and resources to successfully navigate the process and obtain FDA clearance for their medical devices.

Device Trials Performance Data and Substantial Equivalent Comparison’

Providing appropriate data and conducting the necessary testing to demonstrate analytical and clinical comparability can be time-consuming and expensive. Complex devices often require more comprehensive testing and a more extensive submission. Manufacturers must provide data and evidence to show the new device is similar to predicate devices, to justify the new device can be cleared for marketing. Also, providing evidence to support the claim can be intricate, particularly for unique devices.

How TriCore Research Institute Can Help With 510(k) Submissions

It’s crucial to select a partner capable of managing testing complexities, such as gathering performance data and facilitating substantial equivalence comparisons. For the past 25 years, TriCore has provided performance data on over 400 FDA submissions, specializing in in vitro diagnostic instruments. With a cumulative expertise of over a century in device trials leadership, we possess the knowledge and resources to expedite your device trials to completion.

Our clients benefit from:

• GCP-certified scientists, principal investigators, and technologists with expertise in clinical and anatomic pathology disciplines
• A dedicated team of experienced, certified research technologists and coordinators, operating independently from the clinical laboratory
• Extensive experience with a multitude of predicate devices and methods suitable for substantial equivalent comparisons

510(k) Submissions – Words of Wisdom

With decades of work experience, the Device Trials team offers the following guidance for sponsors:

• Engage with the FDA early on. Initiate discussions with your FDA counterpart at the beginning of the trial before you start the planning. Contacting the FDA midway through a trial might necessitate changes, leading to losses in financial investments that may not be acceptable to the FDA.
• Construct a realistic timeline that accommodates unforeseen surprises and interruptions.
• Acknowledge the unpredictability of events and avoid underestimating their impact.

The Device Trials team takes pride in its values of transparency, trust, friendliness, and flexibility.
For any inquiries, please contact us at researchcoordinators@tricore.org.