July 24, 2015
By Email at udi@fda.hhs.gov
UDI Regulatory Policy Support
Center for Device and Radiological Health
U.S. Food and Drug Administration
Building 66, Room 3303
10903 New Hampshire Avenue
Silver Springs, MD 20993
Re:
Application for an Exception to Labeling, Reporting, and
Recordkeeping Requirements for Unique Device Identification
Dear Sir or Madam:
By way of this application and pursuant to 21 CFR §§801.20(b) and 801.55,
[COMPANY NAME], located at [COMPANY ADDRESS], respectfully requests an exception
to the labeling, reporting and record keeping requirements for unique device identification
(“UDI”) of ophthalmic lens blanks, uncut, finished lenses and finished prescription lenses used
in the manufacture of prescription eyeglasses. [COMPANY NAME] manufactures and
distributes [GIVE AN OVERVIEW OF THE COMPANY]
REASON FOR REQUESTING AN EXCEPTION
FROM UDI LABELING AND REPORTING REQUIREMENTS
1.
Identity of device that would be subject to exception.
This request for exception would apply to lenses used to make prescription eyewear,
made of plastic or glass, in their state as a) finished prescription lenses, where both surface and
edging operations have been completed, and coating and treatment for impact resistance has been
applied; 2) uncut, finished lenses, where both surfaces have been optically worked but the lenses
have not yet been edged; and 3) lens blanks, which are semi-finished lenses where one surface
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July 24, 2015
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has been shaped or molded to a specific base curve and the lenses have yet to be ground or
edged.
2.
Identify the provisions of this subpart that
are the subject of this request for an exception.
This request seeks an exception to the UDI labeling regulations set out in 21 CFR
§801.20(a), and by reference therein, to the UDI requirements set out in 21 CFR §§ 830.10,
830.20, 830.40, 830.50, and 830.60 in that [COMPANY NAME] believes that it is not a
“labeler” as defined by those regulations. Reference is also made to 21 CFR §801.30(a)(5) and
21 CFR 812.3(b), in that the applicant submits that finished prescription lenses are custom
devices, thus warranting the granting of an exception to the finished product, as well as to the
lens blanks and uncut, finished lenses from which the prescription lenses are made.
This request also seeks an exception to the regulatory requirements that information be
submitted into the Global Unique Device Identification Database (“GUDID”) pursuant to 21
CFR §§ 830.310, 830.320, 830.330, 830.340 and 830.360.
It also seeks exception to UDI record keeping requirements as mandated by 21 C.F.R. §
830.360.
3.
Explanation as to why the UDI requirements are not technologically feasible.
A.
Overview of lens manufacturing process.
A description of the means by which lens blanks and uncut, finished lenses are processed
into finished prescription lenses used in the manufacture of prescription eyeglasses is set out
below to assist in understanding why compliance with the UDI regulations is not feasible and
why an exception is merited. Typically, three levels of the lens supply chain are involved in the
production of finished prescription lenses1, each of which is regulated differently by the FDA: 1)
1
Prescription lenses are regulated by the FDA as class I medical devices. They are
classified under the FDA regulations as “Lens, Spectacle, Non Custom (Prescription)”, assigned
classification HQG, and defined at 21 CFR § 886.5844 as “[a] prescription spectacle lens is a
glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to
provide refractive corrections in accordance with a prescription for the patient.”
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U.S. Food and Drug Administration
July 24, 2015
Page 3
the manufacturer of the lens blanks, or in some cases, the uncut, finished lenses, which produce
and sell these primary components for further processing into finished lenses2; 2) the entity,
typically an optical laboratory but could be an eye care professional (“ECP”) that has lab
capabilities, which further processes the lens blanks or uncut, finished lenses into the finished
prescription lenses3 and inserts them in the spectacle frames, and 3) the ECP4, who sells to the
end user finished prescription eyewear incorporating the finished lenses ground to that end user’s
custom prescription.5
It is likely you are familiar with how eyeglasses are dispensed. An individual goes for an
eye exam conducted by an ophthalmologist or optometrist, after which that doctor writes a
prescription unique to, and corrective of, that patient’s specific vision deficiency. This
prescription takes into account the patient’s need for a variety of different corrective factors. For
example, it will set out the lens power, known as sphere and measured in diopters, necessary to
correct nearsightedness or farsightedness. If the patient has an astigmatism, then the lens power
(known as cylinder) necessary to correct that problem is set out, as well as the axis used to
identify the position of the astigmatism. Eye alignment problems are corrected via prismatic
2
The lens blank manufacturer, or a manufacturer of uncut, finished lenses, is subject to
FDA registration, listing, and good manufacturing practices (“GMP”). Lens blanks are not
subject to impact resistance, whereas impact resistance testing can be done on uncut, finished
plastic lenses.
3
The optical laboratory is exempt from FDA registration and listing. See, 42 F.R. 42522
(Aug. 23, 1977)(“the Commissioner believes that full service [optical] laboratories and similar
establishments are exempt from registration.”). Likely, its operations will trigger the impact
testing requirement on the now-processed lenses.
4
Like the optical laboratory, the ECP is exempt from FDA registration and listing. See 21
C.F.R. § 807.65(d)(exempting licensed practitioners, including physicians and optometrists) and
§ 807.65(e)(exempting persons who dispense devices to the ultimate consumer; includes
opticians). Unless the ECP also created the finished prescription lenses from the lens blanks or
uncut, finished lens, the ECP would not conduct impact testing.
5
To our knowledge the FDA does not regulate finished eyeglasses as discrete medical
devices. The FDA regulations do not provide a classification for finished eyeglasses, nor is there
a device listing for them. Nothing in the regulations subjects prescription eyeglasses to GMPs or
premarket approval. Rather, the FDA regulates the components of finished eyeglasses as
specific devices – spectacle lenses at 21 C.F.R. § 886.5844 and spectacle frames at 21 C.F.R.
886.5842.
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U.S. Food and Drug Administration
July 24, 2015
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powers. Pupillary distance and optical center of correction will also be measured to align the
lens properly with the patient’s pupils. Recommendation might also be made as to a preferred
type of lens material to be used, which relates to a specific index of refraction, as well as other
factors unique to that patient that will be applied to the final prescriptive device. In sum, this
type of information is provided uniquely for both eyes, resulting in a prescription customized to
correct one individual patient’s vision deficiencies.
That customer then has the prescription filled at some form of optical store. This could
be a single, “small business” brick and mortar store. It could be part of the ophthalmologist’s or
optometrist’s office. It could be a well-known national optical chain. It could be an optical
department within a mass merchandiser or “big box” store. It could be via the internet.
Thereafter, the patient’s written prescription is converted into the necessary corrective
lens and then placed in the eyeglass frame. This could be filled directly at the point where the
glasses are being purchased if the dispenser has the facility to finish lens blanks or uncut,
finished lenses into prescription lenses. Alternatively, and more commonly, the prescription is
sent to an optical lab.
At the lab, lens blanks are mounted into a milling machine for machining. Lens blanks
are plastic or glass disks that have not yet been optically worked to meet a specific prescription
or cut to fit an eyeglass frame, and are manufactured by mass lens manufacturers. Lens blanks
are typically convex on one side and concave on the other, with the convex side coming in
several different base curves. Lens blank manufacturers sell blanks of different base curves to
optical labs and other entities that further process them into unique corrective lenses for a
specific individual.
The eye doctor’s prescription is scanned electronically into the milling machine, and the
machine then reshapes the lens blank via the milling process so that the thicknesses and
curvature required by the prescription is created. Thereafter, the lens is polished to optical
quality. After this processing, the lenses would be considered uncut, finished lenses, typically
single vision.6 The blank has now been converted into an optically unique, custom lens with the
required optical through-power as per the prescription. The lenses are then cleaned, and treated
via multiple steps rendering them scratch resistant, anti-reflective and tinted, depending on the
6
Single vision lenses are prescribed when a patient needs correction for one field of vision,
ie, the patient is nearsighted or farsighted. A lens would have the same optical focal point or
correction over the entire area of the lens. Single vision lenses differ from bi-focal or multi-focal
lenses, which provide more than one field of correction.
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U.S. Food and Drug Administration
July 24, 2015
Page 5
specifics of the order.7 The lenses are then cut to the shape necessary to fit into the eyeglass
frame, and then fitted and secured into the frame.
Alternatively, some mass lens manufacturers, using “in house” optical laboratory
technology, produce and sell uncut, finished lenses too. Thus, an optical lab or patient’s ECP
could start with uncut, finished lenses rather than lens blanks, and then further process them into
finished lenses for insertion into the eyeglass frame in the same manner described above.
As this description makes clear, the finished prescription lenses are the direct result of the
need to create a unique medical device with characteristics required for a specific patient and
prescribed by a medical doctor. The intent is that the lenses are being custom made for a specific
patient to correct that patient’s vision deficiency and not for general use by someone other than
that patient. It also shows that [COMPANY NAME] and other manufacturers of lens blank and
uncut, finished lenses understand that their products will be further processed by third parties
before they can be used as prescription lenses in a pair of prescription eyeglasses.
B.
Reasons why [COMPANY NAME] should be exempt from UDI requirements.
a.
[COMPANY NAME] is not a “Labeler” pursuant to 21 C.F.R.§ 801.3.
As described above, [COMPANY NAME] and other similar manufacturers know that
their lens blanks and uncut, finished lenses will be further processed before their ultimate use as
a “device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive
corrections in accordance with a prescription for the patient.” 21 C.F.R. § 886.5844. Therefore,
[COMPANY NAME] respectfully submits that it will not cause “a label to be applied to a device
with the intent that the device will be commercially distributed without any intended subsequent
replacement or modification of the label” because it knows that any label it applies, UDI or
otherwise, will be discarded by downstream entities that are further processing the lens blanks or
uncut, finished lenses into the specific prescription eyeglasses that are finally dispensed.
Therefore, for the following reason we request that the FDA confirm for [COMPANY NAME]
that it is exempt from UDI labeling, GUDID reporting, and UDI record keeping because it does
not meet the definition of a “labeler.”
7
Depending on the capabilities of the entity processing the blank or uncut-finished lens
into a finished lens, during this process the milled lens could be forwarded to multiple entities for
additional processing for anti-abrasion, anti-reflection and/or tinting, or the actual
grinding/edging of the lens for insertion into the frames. These additional steps would be
contingent on the ultimate end user’s specific order and the in-house capabilities of those entities
involved in producing the final product.
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July 24, 2015
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Pursuant to 21 C.F.R. § 801.3, a UDI labeler is the entity that causes the label to be
applied to the device’s packaging with the intent that it be commercially distributed without
replacement or modification to the label. We believe that this definition excludes [COMPANY
NAME] and other mass lens manufacturers, including those that sell uncut, finished lenses, as
“labelers” because those lens blanks or uncut, finished lens will be removed by third-parties from
[COMPANY NAME]’s packaging and will require additional processing and/or assembly into
finished eyeglasses. The FDA recognizes that this additional processing and/or assembly can
potentially change the properties of the original lens blank or uncut, finished lenses.8
After this additional processing is completed, the now uncut, finished lenses, finished
lenses, or finished eyeglasses, depending on where the product is in the prescription lens supply
chain, typically are not repackaged and relabeled for delivery for additional processing/assembly,
or in the case of finished prescription eyeglasses, delivery to the patient. In fact, finished
prescription eyeglasses are dispensed to the patient without repackaging or generating new labels
that could even contain a UDI from which the patient could track back into the GUDID, or track
back into a UDI that [COMPANY NAME] had assigned to its lens blank or uncut, finished lens
which had been used to make the patient’s lenses. Any benefit derived from requiring UDI
labeling on [COMPANY NAME]’s lens blanks, uncut, finished lenses or on the finished lenses
processed therefrom is negated by this fact, as the recipient of the finished prescription
eyeglasses, having received them with no labeling or packaging, cannot tie the eyeglass lenses to
[COMPANY NAME]’s lens blank or uncut, finished lenses via any UDI originally placed on
[COMPANY NAME]’s product label. Moreover, labeling these initial components cannot
provide complete or the most meaningful information about the final product when it is known
the lens blanks or uncut, finished lenses will undergo significant processing to create the final
prescribed and dispensed eyeglasses.
In light of this, [COMPANY NAME] is not a “labeler” as contemplated by 21 C.F.R. §
801.3 because it does not have the intent that any label it may place on its products will be
commercially distributed to its ultimate user without replacement, modification, or in most cases,
removal by downstream parties that process the blanks or uncut, finished lenses into finished
prescription eyeglasses lenses. Because the lens blank manufacturer or the manufacturer of
That is why the FDA recommends testing by “the person (or firm) who puts the lens in
the form ready for its intended use or who alters the physical or chemical characteristics of the
lens by grinding, heat treating, beveling, applying scratch resistant coating, applying antireflection coating, cutting or other pertinent actions.” See Questions 20 and 21, Guidance for
Industry and FDA Staff. Impact-Resistant Lenses: Questions and Answers, issued September 2,
2010, U.S. Department of Health and Human Services.
8
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U.S. Food and Drug Administration
July 24, 2015
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uncut, finished lenses9 is not a “labeler” as defined by the UDI regulations, [COMPANY
NAME] believes that it is exempt from responsibility for complying with UDI label, data
submission and record keeping requirements, and requests that the FDA confirm this via a
written exception.
b.
Prescription lenses, and components
thereof, should be exempt as custom devices.
In addition to [COMPANY NAME]’s request that the FDA confirm that [COMPANY
NAME] is exempt from UDI compliance because it is not a “labeler” as defined in 21 C.F.R. §
801.3, [COMPANY NAME] also respectfully requests that the FDA make a determination that
prescription lenses, and the lens blanks and/or uncut, finished lenses from which the finished
lenses are made, are “custom devices” and thus exempt from the UDI requirements. In turn, this
would also exempt [COMPANY NAME] from UDI compliance. The UDI regulations at 21
C.F.R. § 801.30(a)(5) provide that custom devices may be exempted from the UDI: “The
following types of devices are excepted from the requirements of §801.20: . . . (5) A custom
device within the meaning of 812.3(b) of this chapter.” [COMPANY NAME] believes that
prescription lenses, and by extension lens blanks and uncut, finished lenses used as components
of finished prescription lenses, should be treated as custom medical devices and be exempt from
the UDI.
The UDI regulations on custom devices cross reference 21 C.F.R. § 812.3(b), which
defines a customs device as follow: “Custom device means a device that: (1) Necessarily
deviates from devices generally available or from an applicable performance standard or
premarket approval requirement in order to comply with the order of an individual physician or
dentist; (2) Is not generally available to, or generally used by, other physicians or dentists; (3) Is
not generally available in finished form for purchase or for dispensing upon prescription; (4) Is
not offered for commercial distribution through labeling or advertising; and (5) Is intended for
9
This would include uncut, finished lenses produced by optical laboratories from lens
blanks. As with the uncut, finished lenses originally produced by [COMPANY NAME], uncut,
finished lenses, and finished lenses, produced by optical laboratories from lens blanks produced
by [COMPANY NAME] are typically not repackaged and relabeled prior to being assembled
into prescription eyeglasses. Clarifying that all entities that make uncut, finished and finished
lenses are exempt from UDI compliance would reflect the commercial and regulatory reality of
the prescription eyeglasses market, where no labels are being generated that could disseminate
UDI information to the ultimate user of the prescription product, and where ECPs and the
finished eyeglasses they sell have historically been outside of FDA scrutiny.
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July 24, 2015
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use by an individual patient named in the order of a physician or dentist, and is to be made in a
specific form for that patient, or is intended to meet the special needs of the physician or dentist
in the course of professional practice.”
[COMPANY NAME] respectfully submits that finished prescription lenses made from its
lens blanks or uncut, finished lenses and used to make finished prescription eyeglasses meet this
definition.10 As described above, finished prescription lenses result from further processing of
lens blanks or uncut, finished lenses to achieve a desired prescription issued by a doctor for a
specific patient, and which is intended to be used by that single individual, thus satisfying
criterion 5. Criterion 1 is met because finished lenses are unique to each intended end user and
are custom ground to achieve such results. Each prescription lens is different from each other
prescription lens, unless purposely ground to achieve the same optical properties. In this regard,
no standard prescription lens is “generally available” from which another can be deemed to be a
deviation therefrom, because each prescription lens is unique and thus by definition deviates
from each other prescription lens. We believe that this establishes that criterion 1 is satisfied in
that all prescription lenses are customized to meet the doctor’s prescription, and thus are unique
from each other. In turn, this supports the conclusion that criterion 3 is satisfied because
prescription lenses are not available in finished form for purchasing or dispensing. They are not
“stock” items. Instead, the lens blanks or uncut, finished lenses sold by [COMPANY NAME]
and like companies are ground and finished specifically to achieve a custom device required by
the doctor and defined by the prescription.
It is true that [COMPANY NAME] and its competitors advertise their products, typically
focusing on properties not covered by a prescription but which the end user might desire. This
might include the material of the lens (plastic or glass), or the ability of it to adapt from clear to
dark, to block ultraviolet rays, to withstand certain levels of impact, or to provide multi-focal
properties. These features, however, do not go to the root function of a lens that the FDA seeks
to regulate – to “provide refractive corrections in accordance with a prescription for the patient.”
21 C.F.R. § 886.5844. In this light, prescription lenses are not being “offered for commercial
distribution through labeling or advertising” to the end user. The end user may choose a set of
features to enhance the ultimate functionality of the finished eyeglass, but as stated above,
finished prescription lenses are not offered or advertised for sale as stock items. They are
[COMPANY NAME] also notes that 21 C.F.R. § 812.3(b) was drafted to apply when
exceptions were sought from the requirement that a device undergo clinical investigations to
determine its safety and effectiveness. We question whether the regulatory intent underlying the
original promulgation of this definition is applicable in the current setting, where there is no
issue about the device’s safety and effectiveness but rather whether it should be exempt from
UDI because it is a custom device made to meet a specific end user’s prescription.
10
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Center for Device and Radiological Health
U.S. Food and Drug Administration
July 24, 2015
Page 9
custom devices ground to provide the optical properties required pursuant to the doctor’s
prescription to remedy the individual patient’s visual deficiency.
The final criterion of section 812.3(b) requires that a customs device “not generally [be]
available to, or generally used by, other physicians or dentists.” The fact that other doctors could
write a prescription and have [COMPANY NAME]’s lens blanks or uncut, finished lenses
ground to meet that prescription does not change the fact that the finished prescription lenses
used to make finished prescription eyeglasses have been custom made to meet the discrete
remedial requirements of one individual patient. Too narrow a reading of the criterion would
eliminate from its scope any customs device that could possibly be replicated by other doctors or
dentists, notwithstanding that the device was custom made to meet the medical requirements of a
specific individual and was not intended to be used by anyone else. [COMPANY NAME] does
not believe that the goal of providing relief to custom device manufacturers from UDI
compliance is promoted by reading this criterion to, in effect, eliminate from the exception
“customs” devices that are capable of replication.11
If the FDA agrees that prescription lenses are customs devices that are outside the scope
of the UDI, then extending that exception back upstream to the lens blank and uncut, finished
lens manufacturers makes sense. If the prescription lenses and/or finished prescription eyewear
actually used by the consumer are outside the scope of the UDI so that no labeling or UDI
compliance is required from which the consumer could tie into the GUDID, then requiring UDI
labeling and compliance for the lens blanks or lenses in uncut-finished form, would provide no
benefit consistent with the UDI’s goals either. If the actual medical device regulated by the FDA
(a prescription lens as per 21 C.F.R. § 886.5844) is found to be exempt from UDI compliance as
a custom device, then the components used to make that finished device should be exempt too as
parts of that custom device.
4.
Number or labelers and devices likely
affected if this request for exception is allowed.
[COMPANY NAME] estimates that between 35 and 40 other suppliers of lens blanks
and uncut-finished lenses could be affected by this request in that those companies put into the
commerce lens blanks that are further processed by downstream entities into finished
prescription lenses. Based on recent industry statistics for year-end 2014, [COMPANY NAME]
11
It should also be noted that the ECP might also recommend a certain type of frame given
the patient’s face shape. This is another potential factor that demonstrates the custom nature of
the finished eyeglasses.
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Center for Device and Radiological Health
U.S. Food and Drug Administration
July 24, 2015
Page 10
estimates that approximately 80 million lens blanks were supplied by lens blank and uncutfinished lens12 manufacturers into the U.S. domestic market, and that approximately the same
number of units of finished, prescription lenses was sold at retail to consumers of prescription
eyeglasses.
CONCLUSIONS
For the reasons stated above, [COMPANY NAME] submits that it has established good
cause for a determination by the FDA that its compliance with the UDI regulations is not
required. In the event that the FDA disagrees with [COMPANY NAME] position, then we
request the opportunity to meet with the FDA before any such decision is made final. If the
Center Director requires any additional information relating to this petition for exception or
alternative so to clarify its scope or effect then please feel free to contact the undersigned.
Very truly yours,
12
Of the 80.7 million pairs of lenses, approximately 23.8 million pairs are uncut-finished
single vision lenses.