FDA product code NFD: Selector, Color, Spectacle, Lens, Tint

NFD is the FDA product code for selector, color, spectacle, lens, tint. It is a Class I device, regulated under 21 CFR 886.1160 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NFD. The average 510(k) review took 68 days (median 68).

Classification

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Top NFD applicants

Most recent NFD clearances

Recalls for NFD devices

openFDA lists no recalls for product code NFD.

Frequently asked questions

What is FDA product code NFD?

NFD is the FDA product code for selector, color, spectacle, lens, tint. It is a Class I device, regulated under 21 CFR 886.1160 and reviewed by the Ophthalmic panel.

What device class is NFD?

Class I, regulation 21 CFR 886.1160. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code NFD?

Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).

Which companies have the most NFD clearances?

Cerium Optical Technologies, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code NFD
• Run a recall and safety report across every NFD manufacturer
• Watch product code NFD for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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