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Are sunglasses medical devices?

Updated

Short answer

Yes, Class I devices, exempt from 510(k).

FDA classifies nonprescription sunglasses as Class I medical devices in 21 CFR 886.5850, exempt from premarket notification (510(k)). That still brings device rules: lenses must be impact resistant and pass the drop ball test in 21 CFR 801.410, foreign manufacturers must register and list with FDA and name a U.S. agent, and initial importers register too.

What changes the answer

  • What counts. 886.5850 covers spectacle frames or clips with absorbing, reflective, tinted, polarizing or photosensitized lenses meant to protect the eyes from bright sunlight, without refractive correction. Clip-ons are included.
  • Impact resistance. 801.410 requires impact-resistant lenses in sunglasses. Nonprescription lenses are tested on a statistically significant sample from each production batch, in finished or uncut-finished form, using the drop ball referee test: a 5/8 inch steel ball dropped from 50 inches.
  • Who registers. Under 21 CFR 807.20, specification developers, repackagers, relabelers and initial importers must register. 807.40 requires each foreign manufacturing establishment to register, list its devices and designate a U.S. agent. An initial importer can meet its listing duty by naming the manufacturer.
  • Other glasses. Blue light glasses without correction and fashion glasses with clear lenses are not sunglasses under 886.5850 but may be other device types.

What to do

  1. Confirm the factory's FDA establishment registration and device listing for sunglasses and its U.S. agent.
  2. Register as an initial importer if you are one, and pay the annual establishment registration user fee that applies to registered establishments.
  3. Get drop ball test results for each lens batch, and keep them. FDA can ask for them at entry.
  4. Keep labeling truthful: UV protection claims should be supported by testing. Health claims beyond protecting eyes from bright sunlight can change the device type.
HTS line for sunglasses
  • 9004.10.00.00

    9004: Spectacles, goggles and the like, corrective, protective or other

    Sunglasses

    Sunglasses. FDA reviews these entries as medical device imports.

    General rate
    2%
    Free or reduced under 18 programs

Next steps

Frequently asked questions

Do I need a 510(k) for sunglasses?
No. Nonprescription sunglasses are exempt from premarket notification under 886.5850(b), subject to the limitations in 886.9.
Does an Amazon seller importing sunglasses need FDA registration?
If you are the initial importer, 21 CFR 807.20(a)(5) requires registration, and you can satisfy listing by giving the manufacturer's name and address. The foreign factory must be registered and listed too.
Is UV400 testing required by FDA?
FDA's rule requires impact resistance, not a UV rating. A UV400 claim on the label must be truthful, so test it if you make it.

Sources

  1. 21 CFR 886.5850, Sunglasses (nonprescription), eCFR, National Archives
  2. 21 CFR 801.410, Use of impact-resistant lenses in eyeglasses and sunglasses, eCFR, National Archives
  3. 21 CFR 807.20, Who must register and submit a device list, eCFR, National Archives
  4. 21 CFR 807.40, Registration and listing for foreign establishments, eCFR, National Archives
  5. 21 CFR part 807, Establishment registration and device listing, eCFR, National Archives

This is general information drawn from the official sources linked above. It is not legal advice. Rules change and often turn on the facts of your product, so confirm your test plan with an accredited lab and your obligations with qualified counsel before you import or sell.