The Chattanooga region has seen meaningful growth in life sciences activity. For medical device and diagnostic startups, understanding the FDA regulatory pathway early can make or break a product launch.
The Tennessee Valley has historically been associated with manufacturing and distribution. Over the past decade, that profile has begun to shift. Chattanooga has attracted a cluster of medical device, diagnostic, and health technology companies drawn by the region's manufacturing infrastructure, University of Tennessee at Chattanooga research capabilities, and proximity to major Southeast healthcare systems. For founders and operators in this space, understanding the legal and regulatory landscape early is essential.
Medical device companies routinely underestimate the importance of early FDA strategy. The classification of your device — Class I, II, or III — determines your regulatory pathway, your timeline, and your cost of market entry. A Class II device cleared through the 510(k) process must demonstrate substantial equivalence to a predicate device. Getting the predicate selection right is a strategic decision that should involve regulatory counsel alongside your scientific team. A mistake here can add 12 to 18 months to your timeline.
Even before you have a product on the market, FDA expects you to have a Quality Management System in place. For most device companies, this means compliance with 21 CFR Part 820 — the Quality System Regulation — or its updated counterpart under the FDA's transition to ISO 13485. Building your QMS from the ground up during development is far less expensive than retrofitting it after the fact. We have seen companies spend hundreds of thousands of dollars correcting QMS deficiencies identified during pre-submission meetings with FDA.
In addition to FDA requirements, medical device companies in Tennessee are subject to state regulatory requirements, including those of the Tennessee Department of Health for certain device categories. Companies that engage in clinical trials in Tennessee must also comply with state-specific requirements that go beyond federal IRB rules. And companies that receive Tennessee state grants or incentives for life sciences development should be aware of the compliance obligations attached to that funding.
One financing avenue that remains underutilized in the life sciences space is EB-5 immigrant investor capital. Evans Harrison Hackett has structured EB-5 transactions for laboratory and manufacturing facilities in the Southeast. For companies building out physical infrastructure, EB-5 can provide patient, lower-cost capital that complements venture and grant funding.
Mark Hackett represents life sciences companies throughout the Southeast on regulatory, transactional, and financing matters. He is a co-founder of Solas BioVentures and brings hands-on industry experience to his legal practice. Contact us at 423.648.7890.
Attorney Advertising. This article is provided for informational purposes only and does not constitute legal advice. Reading this article does not create an attorney-client relationship. For advice specific to your situation, please contact Evans Harrison Hackett PLLC at 423.648.7890.