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of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

(b) The exemptions conferred by $8 801.119, 801.122, and 801.125 shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502(f)(1) of the act. If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by 8 801.109.

Subpart E-Other Exemptions 8801.150 Medical devices; processing,

labeling, or repacking. (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of section 502(b) and (f) of the act if:

(1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such device is to be processed, labeled, or repacked; or

(2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such device in such establishment as will insure, if such specifications are followed, that such device will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the

final shipment or delivery of such device from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(b) An exemption of a shipment or other delivery of a device under paragraph (a)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(c) An exemption of a shipment or other delivery of a device under paragraph (a)(2) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such paragraph (a)(2).

(d) An exemption of a shipment or other delivery of a device under paragraph (a)(2) of this section shall expire:

(1) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(2) Upon refusal by the operator of the establishment where such device is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such clause.

(e) As it is a common industry practice to manufacture and/or assemble, package, and fully label a device as sterile at one establishment and then ship such device in interstate commerce to another establishment or to a contract sterilizer for sterilization, the Food and Drug Administration will initiate no regulatory action against the device as misbranded or adulterated when the nonsterile device is labeled sterile, provided all the following conditions are met:

(1) There is in effect a written agreement which:

(i) Contains the names and post office addresses of the firms involved and is signed by the person authorizing such shipment and the operator or person in charge of the establishment receiving the devices for sterilization.

(ii) Provides instructions for maintaining proper records or otherwise accounting for the number of units in each shipment to insure that the number of units shipped is the same as the number received and sterilized.

(iii) Acknowledges that the device is nonsterile and is being shipped for further processing, and

(iv) States in detail the sterilization process, the gaseous mixture or other media, the equipment, and the testing method or quality controls to be used by the contract sterilizer to assure that the device will be brought into full compliance with the Federal Food, Drug, and Cosmetic Act.

(2) Each pallet, carton, or other designated unit is conspicuously marked to show its nonsterile nature when it is introduced into and is moving in interstate commerce, and while it is being held prior to sterilization. Following sterilization, and until such time as it is established that the device is sterile and can be released from quarantine, each pallet, carton, or other designated unit is conspicuously marked to show that it has not been released from quarantine, e.g., “sterilized-awaiting test results” or an equivalent designation.

refit dentures a person must have professional knowledge and specialized technical skill. Laymen cannot be expected to maintain the original vertical dimension of occlusion and the centric relation essential in the proper repairing or refitting of dentures. The continued wearing of improperly repaired or refitted dentures may cause acceleration of bone resorption, soft tissue hyperplasia, and other irreparable damage to the oral cavity. Such articles designed for lay use should be limited to emergency or temporary situations pending the services of a licensed dentist.

(b) The Food and Drug Administration therefore regards such articles as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act, unless the labeling:

(1)(i) Limits directions for use for denture repair kits to emergency repairing pending unavoidable delay in obtaining professional reconstruction of the denture;

(ii) Limits directions for use for denture reliners, pads, and cushions to temporary refitting pending unavoidable delay in obtaining professional reconstruction of the denture;

(2) Contains in a conspicuous manner the word “emergency” preceding and modifying each indication-for-use statement for denture repair kits and the word “temporary” preceding and modifying each indication-for-use statement for reliners, pads, and cushions; and

(3) Includes a conspicuous warning statement to the effect:

(i) For denture repair kits: “Warning--For emergency repairs only. Long term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This kit for emergency use only. See Dentist Without Delay."

(ii) For denture reliners, pads, and cushions: “Warning-For temporary use only. Longterm use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Until a Dentist Can Be Seen.”

(c) Adequate directions for use require full information of the temporary and emergency use recommended in order for the layman to understand the limitations of usefulness, the reasons

Subparts F-G [Reserved]

Subpart H-Special Requirements

for Specific Devices

$801.405 Labeling of articles intended

for lay use in the repairing and/or refitting of dentures. (a) The American Dental Association and leading dental authorities have advised the Food and Drug Administration of their concern regarding the safety of denture reliners, repair kits, pads, cushions, and other articles marketed and labeled for lay use in the repairing, refitting, or cushioning of illfitting, broken, or irritating dentures. It is the opinion of dental authorities and the Food and Drug Administration that to properly repair and properly

194-069 D-01--2

therefor, and the importance of adher- (e) Regulatory action may be initiing to the warnings. Accordingly, the ated with respect to any article found labeling should contain substantially within the jurisdiction of the act conthe following information:

trary to the provisions of this policy (1) For denture repair kits: Special statement after 90 days following the training and tools are needed to repair date of publication of this section in dentures to fit properly. Home-repaired the FEDERAL REGISTER. dentures may cause irritation to the

$801.410 Use of impact-resistant gums and discomfort and tiredness

lenses in eyeglasses and sunglasses. while eating. Long term use may lead to more troubles, even permanent

(a) Examination of data available on changes in bones, teeth, and gums,

the frequency of eye injuries resulting which may make it impossible to wear

from the shattering of ordinary crown dentures in the future. For these rea

glass lenses indicates that the use of sons, dentures repaired with this kit

such lenses constitutes an avoidable should be used only in an emergency

hazard to the eye of the wearer. until a dentist can be seen. Dentures

(b) The consensus of the ophthalmic that don't fit properly cause irritation

community is that the number of eye and injury to the gums and faster bone

injuries would be substantially reduced loss, which is permanent. Dentures

by the use in eyeglasses and sunglasses that don't fit properly cause gum

of impact-resistant lenses. changes that may require surgery for

(c)(1) To protect the public more adecorrection. Continuing irritation and

quately from potential eye injury, eyeinjury may lead to cancer in the

glasses and sunglasses must be fitted mouth. You must see your dentist as

with impact-resistant lenses, except in

those cases where the physician or opsoon as possible. (2) For denture reliners, pads, and

tometrist finds that such lenses will cushions: Use of these preparations or

not fulfill the visual requirements of

the particular patient, directs in writdevices may temporarily decrease the

ing the use of other lenses, and gives discomfort; however, their use will not

written notification thereof to the pamake the denture fit properly. Special

tient. training and tools are needed to repair

(2) The physician or optometrist a denture to fit properly. Dentures that

shall have the option of ordering glass do not fit properly cause irritation and

lenses, plastic lenses, or laminated injury to the gums and faster bone

glass lenses made impact resistant by loss, which is permanent and may re

any method; however, all such lenses quire completely

denture. Changes in the gums caused by den

shall be capable of withstanding the

impact test described in paragraph tures that do not fit properly may re

(d)(2) of this section. quire surgery for correction. Con

(3) Each finished impact-resistant tinuing irritation and injury may lead

glass lens for prescription use shall be to cancer in the mouth. You must see

individually tested for impact resistyour dentist as soon as possible.

ance and shall be capable of with(3) If the denture relining or repair standing the impact test described in ing material forms a permanent bond

paragraph (d)(2) of this section. Raised with the denture, a warning statement multifocal lenses shall be impact reto the following effect should be in

sistant but need not be tested beyond cluded: "This reliner becomes fixed to

initial design testing. Prism segment the denture and a completely new den- multifocal, slab-off prism, lenticular ture may be required because of its cataract, iseikonic, depressed segment use.”

one-piece multifocal, bioconcave, (d) Labeling claims exaggerating the myodisc and minus lenticular, custom usefulness or the safety of the material laminate and cemented assembly or failing to disclose all facts relevant lenses shall be impact resistant but to the claims of usefulness will be re- need not be subjected to impact testgarded as false and misleading under ing. To demonstrate that all other sections 201(n) and 502(a) of the Federal types of impact-resistant lenses, inFood, Drug, and Cosmetic Act.

cluding impact-resistant laminated

a

new

99

non

a

a

glass lenses (i.e., lenses other than those described in the three preceding sentences of this paragraph (c)(3)), are capable of withstanding the impact test described in this regulation, the manufacturer of these lenses shall subject to an impact test a statistically significant sampling of lenses from each production batch, and the lenses so tested shall be representative of the finished forms as worn by the wearer, including finished forms that are of minimal lens thickness and have been subjected to any treatment used to impart impact resistance. All prescription lenses and plastic prescription lenses tested on the basis of statistical significance shall be tested in uncut-finished or finished form.

(d)(1) For the purpose of this regulation, the impact test described in paragraph (d)(2) of this section shall be the "referee test," defined as “one which will be utilized to determine compliance with a regulation." The referee test provides the Food and Drug Administration with the means of examining a medical device for performance and does not inhibit the manufacturer from using equal or superior test methods. A lens manufacturer shall conduct tests of lenses using the impact test described in paragraph (d)(2) of this section or any equal or superior test. Whatever test is used, the lenses shall be capable of withstanding the impact test described in paragraph (d)(2) of this section if the Food and Drug Administration examines them for performance.

(2) In the impact test, a 5/8-inch steel ball weighing approximately 0.56 ounce is dropped from a height of 50 inches upon the horizontal upper surface of the lens. The ball shall strike within a 5/8-inch diameter circle located at the geometric center of the lens. The ball may be guided but not restricted in its fall by being dropped through a tube extending to within approximately 4 inches of the lens. To pass the test, the lens must not fracture; for the purpose of this section, a lens will be considered to have fractured if it cracks through its entire thickness, including a laminar layer, if any, and across a complete diameter into two or more separate pieces, or if any lens material visible to the naked eyes becomes de

tached from the ocular surface. The test shall be conducted with the lens supported by a tube (1-inch inside diameter, 11/4-inch outside diameter, and approximately 1-inch high) affixed to a rigid iron or steel base plate. The total weight of the base plate and its rigidly attached fixtures shall be not less than 27 pounds. For lenses of small minimum diameter, a support tube having an outside diameter of less than 144 inches may be used. The support tube shall be made of rigid acrylic plastic, steel, or other suitable substance and shall have securely bonded on the top edge a 18- by 1/8-inch neoprene gasket having a hardness of 4045, as determined by ASTM Method D 1415–88, “Standard Test Method for Rubber Property-International Hardness" minimum tensile strength of 1,200 pounds, as determined by ASTM Method D 412-98A, "Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension, and minimum ultimate elongation of 400 percent, as determined by ASTM Method D 412-68 (Both methods are incorporated by reference and are available from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428, or available for inspection at the Center for Devices and Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 20850, or at the Office of the Federal Register, 800 North Capitol St., N.W., suite 700, Washington, DC. The diameter or contour of the lens support may be modified as necessary so that the 18- by 48-inch neoprene gasket supports the lens at its periphery.

(e) Copies of invoice(s), shipping document(s), and records of sale or distribution of all impact resistant lenses, including finished eyeglasses and sunglasses, shall be kept and maintained for a period of 3 years; however, the names and addresses of individuals purchasing nonprescription eyeglasses and sunglasses at the retail level need not be kept and maintained by the retailer. The records kept in compliance with this paragraph shall be made available upon request at all reasonable hours by any officer or employee of the Food and Drug Administration or by any other officer or employee acting on behalf of the Secretary of Health and

as

Human Services and such officer or employee shall be permitted to inspect and copy such records, to make such inventories of stock as he deems necessary, and otherwise to check the correctness of such inventories.

(f) In addition, those persons conducting tests in accordance with paragraph (d) of this section shall maintain the results thereof and a description of the test method and of the test apparatus for a period of 3 years. These records shall be made available upon request at any reasonable hour by any officer or employee acting on behalf of the Secretary of Health and Human Services. The persons conducting tests shall permit the officer or employee to inspect and copy the records, to make such inventories of stock as the officer or employee deems necessary, and otherwise to check the correctness of the inventories.

(g) For the purpose of this section, the term "manufacturer” includes an importer for resale. Such importer may have the tests required by paragraph (d) of this section conducted in the country of origin but must make the results thereof available, upon request, to the Food and Drug Administration, as soon as practicable.

(h) All lenses must be impact-resistant except when the physician or optometrist finds that impact-resistant lenses will not fulfill the visual requirements for a particular patient.

(i) This statement of policy does not apply to contact lenses. [41 F 6896, Feb. 13, 1976, as am

at 44 FR 20678, Apr. 6, 1979; 47 FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000]

the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration.

(c) A number of devices currently on the market generate ozone by design or

a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions:

(1) In such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air (when measured under standard conditions at 25 °C (77 °F) and 760 millimeters of mercury) in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices. This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product.

(2) To generate ozone and release it into the atmosphere in hospitals or other establishments occupied by the ill or infirm.

(3) To generate ozone and release it into the atmosphere and does not indicate in its labeling the maximum acceptable concentration of ozone which may be generated (not to exceed 0.05 part per million by volume of air circulating through the device) as established herein and the smallest area in which such device can be used so as not to produce an ozone accumulation in excess of 0.05 part per million.

(4) In any medical condition for which there is no proof of safety and effectiveness.

(5) To generate ozone at a level less than 0.05 part per million by volume of air circulating through the device and

$ 801.415 Maximum acceptable level of

Ozone,

(a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.

(b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of

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