ENT Instruments Manufacturers in the United States

Many do not. Under 21 CFR 878.4800, manual surgical instruments for general use (nonpowered, hand-held or hand-manipulated reusable or disposable instruments such as forceps, clamps, scalpels and retractors) are Class I and exempt from 510(k), subject to the limitations in 21 CFR 878.9.

"Exempt" does not mean unregulated. The establishment must still register and list, and labeling, UDI and medical device reporting rules apply. Instruments for specialty uses (for example dental, ophthalmic or orthopedic) are classified in other regulations and may differ, and listing a device as exempt is not proof that it is. Check the classification regulation and product code for each item. See the medical certifications page.

Medical certifications

Ask the supplier for four items, then check them against FDA's public databases:

• the establishment's FDA registration and owner/operator number;
• the device listing, with its product code;
• the classification regulation (for example 21 CFR 878.4800 for many manual instruments) and whether the device is exempt;
• the 510(k), De Novo or PMA number where premarket review was required.

Remember that registration is not approval, and listing an exempt device does not prove the exemption applies. FDA does not issue registration certificates. Use the United States country page to shortlist suppliers, and see the medical certifications page.

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Initial importers are among the establishment types FDA lists as needing to register; FDA's who-must-register table sets out the details. Importers also have medical device reporting duties: report deaths and serious injuries to FDA and the manufacturer, and malfunctions to the manufacturer, within 30 calendar days, electronically.

An importer does not need its own 510(k) if the foreign manufacturer holds one for the device. If an importer relabels or repackages, it takes on additional obligations as a relabeler or repackager. When choosing a US importer or distributor from the United States directory, ask how it handles complaint files, reporting and recalls for the brands it carries.

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In outline, under FDA rules:

• Find the device's classification regulation and product code (many manual instruments fall under 21 CFR 878.4800, Class I and 510(k)-exempt, but specialty instruments may differ).
• Obtain 510(k) clearance, De Novo or PMA if the device type is not exempt.
• Register the foreign establishment with FDA, renew it each year between 1 October and 31 December, pay the annual fee and designate a US agent with a US physical address.
• List each device.
• Meet the QMSR, labeling (21 CFR 801), UDI and medical device reporting rules unless exempted.

Fees change each fiscal year. Browse US-based companies on the United States country page and see the medical certifications page.

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