Focus Practice · Bio & Medical Devices
FDA clearance answers one question. It does not tell you who holds the file, who carries the liability, or what the U.S. distributor is entitled to.
For a device, biologic or aesthetic-medicine manufacturer, several decisions follow one another in sequence: how the product is classified, which FDA pathway follows, who holds the registration, and how the distribution and licensing agreements allocate the resulting responsibility.
The firm does not prepare or file FDA submissions. While your regulatory and technical team and outside consultants handle the pathway and the technical file, the firm takes the legal and contractual side.
Your RA team and consultants
YG Legal Inc.
01
Device class and product code determine the route: a 510(k) with a chosen predicate device, De Novo, or PMA. Which FDA centre reviews the file also depends on whether the product is a device, a drug, a biologic or a combination.
Korean approvals and CE marks are assessed for what does and does not carry over.
02
Establishment registration and device listing, and the U.S. agent and initial importer roles — the agent being the U.S. contact the FDA deals with on the manufacturer's behalf.
Every distribution negotiation has to settle who will hold and control the clearance and the regulatory file — the manufacturer, its U.S. subsidiary or the distributor — and what it costs to move it later.
03
Quality system expectations, labelling and UDI requirements, adverse-event and malfunction reporting, recalls and corrections.
These duties are then allocated between manufacturer, importer and distributor by contract. Inspection and warning-letter response is planned before it is needed.
04
Exclusive distribution and OEM/ODM supply agreements, minimum purchase and territory terms, regulatory cooperation and technology-transfer provisions.
Product liability and indemnity allocation, insurance requirements, and termination terms drafted so that a former distributor does not retain control of the registration or the regulatory file after the agreement ends.
05
Promotional review against the cleared indications, and the risk that arises when communication goes beyond them.
Speaker and KOL arrangements, training programmes for physician customers, and the rules governing payments to U.S. clinicians, including anti-kickback and Sunshine Act reporting.
06
U.S. subsidiary formation and governance, patent and trademark strategy including freedom-to-operate review before launch.
Licensing and royalty flows between parent and subsidiary tested under the Korea–U.S. tax treaty, transfer pricing on intercompany supply, and state tax exposure for a nationwide sales operation. Diligence support for investors, licensees and buyers.
Tell us where the product stands and who you are talking to in the United States. We will look at what needs to be settled in the agreements before it goes further.
Please do not send trade secrets, personal data or other sensitive material before the firm has confirmed that it is able to review your matter.