FDA product code NFF: Device, Storage, Images, Ophthalmic

NFF is the FDA product code for device, storage, images, ophthalmic. It is a Class I device, regulated under 21 CFR 892.2010 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NFF. The average 510(k) review took 22 days (median 22). FDA has posted 1 recall for NFF devices.

Classification

Compare with all 510(k) review times · Search every NFF clearance

Top NFF applicants

Most recent NFF clearances

Recalls for NFF devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-02-05.

Frequently asked questions

What is FDA product code NFF?

NFF is the FDA product code for device, storage, images, ophthalmic. It is a Class I device, regulated under 21 CFR 892.2010 and reviewed by the Ophthalmic panel.

What device class is NFF?

Class I, regulation 21 CFR 892.2010. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).

Which companies have the most NFF clearances?

Carl Zeiss Ophthalmic Systems, Inc. (1).

Have NFF devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2010-02-05.

Next steps

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