The Compliance Management Group
257 Simarano Drive
Marlborough, MA 01752
Telephone: (508) 460-1400
Drop Ball Testing - The Compliance Management Group
Drop Ball Testing Capabilities at Compliance Management Group
Compliance Management Group offers Drop Ball testing using our state of the art Drop Ball Test System specifically designed to meet the FDA’s 21 CFR 801.410 specification. The Compliance Management Group can help guide you through the 21 CFR requirements and provide testing to the CFR 801.410 Drop Ball requirement. We provide a detailed report complete with all the necessary checklist items that the FDA looks for from an importer or registration consultant.
FDA Guidance Document Over view:
Eyewear products regulated by FDA are commonplace in the daily lives of the vast majority
of the general public. FDA believes that impact-resistant lenses are an essential component
of the safe design of these devices.
The use of impact-resistant lenses in eyeglasses and sunglasses is addressed in 21 CFR
801.410. Except in those cases where the physician or optometrist finds that such lenses will
not fulfill the visual requirements of the particular patient, directs the use of other lenses in
writing, and gives written notification to the patient, eyeglasses and sunglasses must be fitted
with impact-resistant lenses (21 CFR 801.410(c)(l)). Glass lenses, plastic lenses, or
laminated glass lenses can be made impact resistant by any method. However, in accordance
with 21 CFR 801.410(~)(2), all such lenses must be capable of withstanding the impact test
described in 21 CFR 801.410(d)(2). Although lenses must be impact resistant, it does not
make the lenses shatterproof.
The number of lenses actually tested for impact resistance within each batch or lot varies
depending on material and type of lens (2 1 CFR 801 -4 10(c)(3)). You must perform impact
testing on each glass lens for prescription use (21 CFR 801.410(~)(3)). However, you may
test a statistically significant sample of lenses from each production batch for testing of over the-
counter (OTC) glass lenses, glass laminate (prescription or OTC), and plastic lenses
(prescription or OTC) for impact resistance. Certain lenses, which are prescribed infrequently
for specific, uncommon visual needs, have physical designs that make them unsuitable for
impact testing. These lenses (see 21 CFR 801.410(~)(3) for specific types) should be rendered impact resistant but need not be tested.
Consumers, manufacturers, and sellers should remember that the strength of any lens is related to the condition of its surface and edge. All lenses lose their impact strength in direct
proportion to the breakdown of the polished and edged surfaces. The greater the number and
depth of scratches or the poorer the edge finish, the weaker the lens becomes. For
consumers, there is an inherent hazard in continuing to wear scratched lenses because their
impact strength is reduced. Spectacle wearers also should be aware that plastic lenses are not necessarily impact resistant simply because they are manufactured of a plastic material.
Documents / items that must be supplied by the Customer prior to testing:
- Collection Report – download pdf here
- Product Along with Product Labeling
- Number of samples determined by FDA recommended Statistical Sampling Plan