What general FDA compliance steps must a [company removed] take to sell a medical device in the US?

We can provide you with a structured, high-level view of FDA requirements tailored to medical devices, and guide you on whether local representation and ongoing legal support are necessary for inspections or enforcement actions. As an international firm, we are equipped to coordinate across jurisdictions and ensure that your expansion into the U.S. market is both compliant and strategically sound. We would be glad to arrange a Zoom meeting to walk you through the regulatory framework and outline how Bourgg can support your entry into the U.S. medical device sector.

Access to the US market is provided by the precise classification of products under the jurisdiction of the FDA (food, supplement, cosmetic, medical device, drug). Pre-market review is applied to certain categories (e.g. medical devices – 510(k)/PMA, drugs), while for others there is no pre-market approval, but strict safety and compliance requirements remain applicable.

The company must ensure:

FDA-compliant labeling (correct, complete, in English, without prohibited claims);

safety and compliance documentation (including technical files, tests, quality procedures, as applicable);

FDA registration of the facility and, where necessary, designation of a U.S. Agent.

Import customs clearance is carried out through a US importer/distributor and a customs broker, with an FDA–Customs and Border Protection interface, and post-market compliance obligations (monitoring, adverse event reporting, recall) fall to the importer and the manufacturer, depending on the product category.

For a foreign company, local representation in the US (FDA lawyer/consultant) is strongly recommended, both for managing the relationship with the FDA and for inspections, warning letters or law enforcement actions, which may occur without prior notice.