What Investors and Strategic Buyers Expect from Your FDA Registration Story
In medical device M&A, regulatory due diligence is often where deal value erodes. Investors and strategic buyers are not just looking at your IP; they are looking for liability. A messy FDA registration history suggests operational sloppiness that translates directly into post-close risk.
Smart buyers look for a "Clean Chain of Custody" in your regulatory data. They want to see that every product you sold was properly listed, every facility was registered, and every change was documented. Gaps in this history—such as selling a device for two years before listing it—create "legacy liability" that buyers will price into the deal (or use to demand larger escrows).
The Three Pillars of a Deal-Ready Profile
1. Rationalized Portfolio: Buyers want to know exactly what is active. If your FURLS account is cluttered with 50 dormant SKUs and old contract manufacturers, it signals a lack of lifecycle control. A lean, accurate listing profile demonstrates governance.
2. Clear U.S. Agent Agreements: For foreign targets, buyers scrutinize the U.S. Agent arrangement. Is it a professional firm, or a random distributor? Professional representation suggests that FDA correspondence has been handled correctly, reducing the risk of hidden warning letters.
3. Import Integrity: A history of smooth customs clearances is a valuable asset. Frequent holds or detentions due to registration errors suggest supply chain fragility that a buyer will have to fix.
BRS LLC: Your Pre-Transaction Partner
We help founders and PE firms prep the regulatory deck before the data room opens.
- Mock Diligence Audit: We review your public FDA data exactly as a buyer's auditor would, finding and fixing red flags early.
- Portfolio Rationalization: We clean up your device listings to present a tight, active commercial portfolio that matches your revenue projections.
- Transition Support: Post-deal, we manage the seamless transfer of registrations and listings to the new owner’s account structure.