Spinal Simplicity announced that its IntraLink technology has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP), following its recent Breakthrough Device Designation. This milestone enhances collaboration with FDA experts and stakeholders to streamline regulatory strategy, address adoption barriers, and accelerate patient access.
OVERLAND PARK, Kan., Sept. 24, 2025 /PRNewswire-PRWeb/ -- Spinal Simplicity, a medical device company dedicated to creating simple, innovative procedure solutions, today announced that its IntraLink technology has been enrolled in the Total Product Life Cycle Advisory Program (TAP). TAP is administered by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
IntraLink was recently designated as a Breakthrough Device , recognizing its potential to provide more effective treatment for patients with serious conditions. The invitation into the TAP program marks another significant step in advancing IntraLink toward clinical adoption.
The TAP program is designed to foster early, frequent, and strategic engagement between device developers, FDA, and non-FDA stakeholders. TAP advisors provide:
- Expertise across multiple fields—including regulatory, technical, and clinical perspectives.
- Proactive identification of key challenges that could impact U.S. marketing authorization.
- Facilitation of discussions with external parties to address potential barriers to market adoption, clinical use, and patient access.
With TAP, FDA aims to play a more active role in supporting patient access to innovative, safe, and effective devices.
"Enrollment in TAP is an important milestone for IntraLink and for Spinal Simplicity," said Adam Rogers, Senior Vice President of Regulatory Affairs at Spinal Simplicity. "We are grateful for the opportunity to be included in the TAP program, where we will benefit from enhanced collaboration with FDA experts and external advisors. This collaboration will help us anticipate challenges earlier, refine our regulatory and market access strategy, and ultimately bring IntraLink to patients and practitioners faster."
Spinal Simplicity remains committed to advancing safe and effective technologies that address unmet clinical needs in spine care. Enrollment in TAP underscores both FDA's recognition of IntraLink's potential and the company's dedication to accelerating patient access to innovative treatment options.
About Spinal Simplicity
Spinal Simplicity is a medical device company dedicated to creating simple, innovative procedure solutions for our physician partners to help improve their patient's pain and quality of life. A life where pain no longer defines the day. That's the future we fight for. Chronic pain steals independence, freedom, and joy. At Spinal Simplicity, we believe patients deserve more—lasting relief, restored mobility, and renewed hope. Visit spinalsimplicity.com/ to learn more.
Media Contact
Parker Snedden, Spinal Simplicity, 1 913.451.4414, [email protected], https://spinalsimplicity.com
SOURCE Spinal Simplicity
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