Entering the US Market: The FDA Regime

The FDA governs the entry of medical device, food, drug and cosmetic products into the US market. The regime varies by product group: for some products facility registration and product listing suffice, while for medical devices a notification or approval process applies according to the risk class.

For manufacturers outside the United States, a representative established in the US (a US Agent) IS MANDATORY and forms part of the facility registration. The US Agent represents the manufacturer in communications with the FDA.

• Facility registration and product listing details
• US Agent appointment details
• For medical devices, the risk class and any 510(k) notification
• Labelling and instructions for use
• Quality system records (for medical devices)
• Product formulation and ingredient details (for food and cosmetics)

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• Facility registration is renewed annually
• For medical devices the class determines the route to be followed
• FDA 'approval' and 'notification' are different processes; the two must not be confused
• For food products, prior notice is a customs condition

1. 01The US medical device arrangement and the MDRBoth rest on risk classification but their evidential logics differ: in the EU a notified body assesses, here the authority grants permission and there is a substantial equivalence route. The documents are not mutually valid.
2. 02The notification route and the approval routeIn the middle risk class an equivalence notification applies and in the highest class an approval process resting on clinical data; the product's class entirely determines the process and the timetable.
3. 03Device approval and facility registrationObtaining permission for a product does not remove the facility registration and quality system obligations; the two run separately and inspection comes to the facility.
4. 04Food contact and medical devicesFor food contact materials the assessment is substance-based and no product approval is granted; although the two arrangements sit under the same authority, they work differently.

There is no separate certification page for this mark; the scope and process are as described on this page. The roadmap specific to your product is provided in writing at the quote stage.

This section's content is being prepared. The roadmap specific to your product and target market at the quote stage in writing.