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after May 5, 1983, are required to be in compliance with all aspects of the regulations without regard to the retail level effective date.
[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 6, 1988]
EFFECTIVE DATE NOTE: A document published at 48 FR 41579, Sept. 16, 1983, stayed the effective date of $800.12(1)(3) until further notice.
or innerseal) as these features are described in the approved premarket approval application. Any supplemental premarket approval application under this paragraph is required to include data sufficient to show that these changes do not adversely affect the product.
(f) Effective date. Each product subject to this section is required to comply with the requirements of this section on the dates listed below except to the extent that a product's manufacturer or packer has obtained an exemption from a packaging or labeling requirement:
(1) Initial effective date for packaging requirements. (i) The packaging requirement in paragraph (b) of this section is effective on February 7, 1983 for each contact lens solution packaged for retail sale on or after that date, except for the requirement in paragraph (b) of this section for a distinctive indicator or barrier to entry.
(ii) The packaging requirement in paragraph (b) of this section is effective on May 5, 1983 for each tablet that is to be used to make a contact lens solution and that is packaged for retail sale on or after that date.
(2) Initial effective date for labeling requirements. The requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive by design and the requirement in paragraph (c) of this section for a labeling statement are effective on May 5, 1983 for each product subject to this section packaged for retail sale on or after that date, except that the requirement for a specific label reference to any identifying characteristic is effective on February 6, 1984 for each affected product subject to this section packaged for retail sale on or after that date.
(3) Retail level effective date. The tamper-resistant packaging requirement of paragraph (b) of this section is effective on February 6, 1984 for each product subject to this section that is held for sale at retail level on or after that date that was packaged for retail sale before May 5, 1983. This does not include the requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive by design. Products packaged for retail sale
$ 800.20 Patient examination gloves
and surgeons' gloves; sample plans and test method for leakage defects;
adulteration. (a) Purpose. The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the Food and Drug Administration (FDA) to look more closely at the quality control of barrier devices, such as surgeons' gloves and patient examination gloves (collectively known as medical gloves) to reduce the risk of transmission of HIV and other blood-borne infectious diseases. The Centers for Disease Control (CDC) recommend that health care workers wear medical gloves to reduce the risk of transmission of HIV and other bloodborne infectious deseases. The CDC recommends that health care workers wear medical gloves when touching blood or other body fluids, mucous membranes, or nonintact skin of all patients; when handling items or surfaces soiled with blood or other body fluids; and when performing venipuncture and other vascular access procedures. Among other things, CDC's ommendation that health care providers
medical gloves demonstrates the proposition that devices labeled as medical gloves purport to be and are represented to be effective barriers against the transmission of bloodand fluid-borne pathogens. Therefore, FDA, through this regulation, is defining adulteration for patient examination and surgeons' gloves as a means of assuring safe and effective devices.
(1) For a description of a patient examination glove, see $880.6250. Finger cots, however, are excluded from the
test method and sample plans in paragraphs (b) and (c) of this section.
(2) For a description of a surgeons' glove, see $ 878.4460 of this chapter.
(b) Test method. For the purposes of this regulation, FDA's analysis of gloves for leaks will be conducted by a water leak method, using 1,000 milliliters (mL) of water. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed. A defect on one of the gloves is counted as one defect; a defect in both gloves is counted as two defects. Defects are defined as leaks, tears, mold, embedded foreigh objects, etc. A leak is defined as the appearance of water on the outside of the glove. This emergence of water from the glove constitutes a watertight barrier failure. Leaks within 1 and 1/2 inches of the cuff are to be disregarded.
(1) The following materials are required for testing: A 23/8-inch by 15-inch (Clear) plastic cylinder with a hook on one end and a mark scored 142 inches from the other end (a cylinder of another size may be used if it accommodates both cuff diameter and any water above the glove capacity); elastic strapping with velcro or other fastening material, automatic water-dispensing apparatus or manual device capable of delivering 1,000 mL of water; a stand with horizontal rod for hanging the hook end of the plastic tube. The support rod must be capable of holding the weight of the total number of gloves that will be suspended at any one time, e.g., five gloves suspended will weigh about 11 pounds.
(2) The following methodology is used: Examine the sample and identify code/ lot number, size, and brand as appropriate. Examine gloves for defects as follows: carefully remove the glove from the wrapper, box, etc., visually examining each glove for defects. Visual defects in the top 142 inches of a glove will not be counted as a defect for the purposes of this rule. Visually defective gloves do not require further testing but are to be included in the total number of defective gloves count
ed for the sample. Attach the glove to the plastic fill tube by bringing the cuff end to the 142-inch mark and fastening with elastic strapping to make a watertight seal. Add 1,000 mL of room temperature water (i.e., 20 °C to 30 °C) into the open end of the fill tube. The water shall pass freely into the glove. (With some larger sizes of long-cuffed surgeons' gloves, the water level may reach only the base of the thumb. With some smaller gloves, the water level may extend several inches up the fill tube.)
(3) Immediately after adding the water, examine the glove for water leaks. Do not squeeze the glove; use only minimal manipulation to spread the fingers to check for leaks. Water drops may be blotted to confirm leaking. If the glove does not leak immediately, keep the glove/filling tube assembly upright and hang the assembly vertically from the horizontal rod, using the wire hook on the open end of the fill tube (do not support the filled glove while transferring). Make a second observation for leaks 2 minutes after addition of the water to the glove. Use only minimal manipulation of the fingers to check for leaks. Record the number of defective gloves.
(c) Sample plans. FDA will collect samples from lots of gloves to perform the test for defects described in paragraph (b) of this section in accordance with FDA's sampling inspection plans which are based on the tables of MILSTD-105E (the military sampling standard, “Sampling Procedures and Tables for Inspection by Attributes," May 10, 1989). Based on the acceptable quality levels found in this standard, FDA has defined adulteration as follows: 2.5 or higher for surgeons' gloves and 4.0 or higher for patient examination gloves at a general inspection level II. FDA will use single normal sampling for lots of 1,200 gloves or less and multiple normal sampling for all larger lots. For convenience, the sample plans (sample size and accept/reject numbers) are shown in the following tables:
35,001 and above
2 7 13 19 25 31 37
35,000 to 10,001
125 125 125 125 125 125 125 80 80 80 80 80 80 80 50 50 50 50 50 50 50
4 8 12 17 21 25
10,000 to 3,201
125 250 375 500 625 750 875
80 160 240 320 400 480 560
50 100 150 200 250 300 350 32 64 96 128 160 192 224 80 50 32 20 5
9 14 19 25 29 33 38
7 10 13 17 20 23 26 5 8 10 13 15 17 19 4 6 8 10 11 12 14 6
11 14 18
3,200 to 1,201
32 32 32
1,200 to 501 500 to 281 280 to 151 150 to 51 50 to 0
10,001 and above
80 80 80 80 80 80 80 50 50 50 50 50 50 50 32 32 32 32 32 32 32
19 25 31 37
10,000 to 3,201
8 12 17 21 25
160 240 320 400 480 560
50 100 150 200 250 300 350 32 64 96 128 160 192 224 80 50 32 20 13 3
9 14 19 25 29 33 38
7 10 13 17 20 23 26 5 8 10 13 15 17 19 8 6 4 3 2 1
3.200 to 1,201
1,200 to 501
(d) Lots of gloves which are tested and rejected using the test method according to paragraph (b) of this section, are adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act, and are subject to regulatory action, such as detention of imported products and seizure of domestic products. (55 FR 51256, Dec. 12, 1990)
Subpart c-Administrative Practices and Procedures
$ 800.55 Administrative detention.
(a) General. This section sets forth the procedures for detention of medical devices intended for human use believed to be adulterated or misbranded. Administrative detention is intended to protect the public by preventing distribution or use of devices encountered during inspections that may be adulterated or misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should take concerning the devices, and to initiate legal action, if appropriate. Devices that FDA orders detained may not be used, moved, altered, or tampered with in any manner by any person during the detention period, except as authorized under paragraph (h) of this section, until FDA terminates the detention order under paragraph (j) of this section, or the detention period expires, whichever occurs first.
(b) Criteria for ordering detention. Administrative detention of devices may be ordered in accordance with this section when an authorized FDA representative, during an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (the act), has reason to believe that a device, as defined in section 201(h) of the act, is adulterated or misbranded.
(c) Detention period. The detention is to be for a reasonable period that may not exceed 20 calendar days after the detention order is issued, unless the FDA District Director in whose district the devices are located determines that a greater period is required to seize the devices, to institute injuction proceedings, or to evaluate the need for legal action, in which case the District
Director may authorize detention for 10 additional calendar days. The additional 10-calendar-day detention period may be ordered at the time the detention order is issued or at any time thereafter. The entire detention period may not exceed 30 calendar days, except when the detention period is extended under paragraph (g)(6) of this section. An authorized FDA representative may, in accordance with paragraph (j) of this section, terminate a detention before the expiration of the detention period.
(d) Issuance of detention order. (1) The detention order shall be issued in writing, in the form of a detention notice, signed by the authorized FDA representative who has reason to believe that the devices are adulterated or misbranded, and issued to the owner, operator, or agent in charge of the place where the devices are located. If the owner or the user of the devices is different from the owner, operator, or agent in charge of the place where the devices are detained, a copy of the detention order shall be provided to the owner or user of the devices if the owner's or user's identity can be readily determined.
(2) If detention of devices in a vehicle or other carrier is ordered, a copy of the detention order shall be provided to the shipper of record and the owner of the vehicle or other carrier, if their identities can be readily determined.
(3) The detention order shall include the following information: (i) A statement that the devices identified in the order are detained for the period shown; (ii) a brief, general statement of the reasons for the detention; (iii) the location of the devices; (iv) a statement that these devices are not to be used, moved, altered, or tampered with in any manner during that period, except as permitted under paragraph (h) of this section, without the written permission of an authorized FDA representative; (v) identification of the detained devices; (vi) the detention order number; (vii) the date and hour of the detention order; (viii) the period of the detention; (ix) the text of section 304(g) of the act and paragraph (g) (1) and (2) of this section; (x) a statement that any informal hearing on an appeal of a detention order shall be conducted as a
regulatory hearing under part 16 of this calendar days after receipt of a detenchapter, with certain exceptions de- tion order. scribed in paragraph (g)(3) of this sec- (2) The appellant of a detention order tion; and (xi) the location and tele- shall state the ownership or propriphone number of the FDA district of- etary interest the appellant has in the fice and the name of the FDA District detained devices. If the detained deDirector.
vices are located at a place other than (e) Approval of detention order. A de- an establishment owned or operated by tention order, before issuance, shall be the appellant, the appellant shall inapproved by the FDA District Director clude documents showing that the apin whose district the devices are lo- pellant would have legitimate authorcated. If prior written approval is not ity to claim the devices if seized. feasible, prior oral approval shall be (3) Any informal hearing on an apobtained and confirmed by written peal of a detention order shall be conmemorandum within FDA as soon as ducted as a regulatory hearing pursupossible.
ant to regulation in accordance with (f) Labeling of marking a detained de- part 16 of this chapter, except that: vice. An FDA representative issuing a (i) The detention order under paradetention order under paragraph (d) of graph (d) of this section, rather than this section shall label or mark the de- the notice under $16.22(a) of this chapvices with official FDA tags that in- ter, provides notice of opportunity for clude the following information:
a hearing under this section and is part (1) A statement that the devices are of the administrative record of the regdetained by the United States Govern- ulatory hearing under $16.80(a) of this ment in accordance with section 304(g) chapter. of the Federal Food, Drug, and Cos- (ii) A request for a hearing under this metic Act (21 U.S.C. 334(g)).
section should be addressed to the FDA (2) A statement that the devices shall District Director. not be used, moved, altered, or tam- (iii) The last sentence of $16.24(e) of pered with in any manner for the pe- this chapter, stating that a hearing riod shown, without the written per- may not be required to be held at a mission of an authorized FDA rep- time less than 2 working days after reresentative, except as authorized in ceipt of the request for a hearing, does paragraph (h) of this section.
not apply to a hearing under this sec(3) A statement that the violation of tion. a detention order or the removal or al- (iv) Paragraph (g)(4) of this section, teration of the tag is punishable by rather than $ 16.42(a) of this chapter, fine or imprisonment or both (section describes the FDA employees, i.e., re303 of the act, 21 U.S.C. 333).
gional food and drug directors, who (4) The detention order number, the preside at hearings under this section. date and hour of the detention order, (4) The presiding officer of a reguthe detention period, and the name of latory hearing on an appeal of a detenthe FDA representative who issued the tion order, who also shall decide the detention order.
appeal, shall be a regional food and (g) Appeal of a detention order. (1) A drug director (i.e., a director of an FDA person who would be entitled to claim regional office listed in $5.115 of this the devices, if seized, may appeal a de- chapter) who is permitted by $16.42(a) tention order. Any appeal shall be sub- of this chapter to preside over the mitted in writing to the FDA District hearing. Director in whose district the devices (5) If the appellant requests a reguare located within 5 working days of latory hearing and requests that the receipt of a detention order. If the ap- hearing be held within 5 working days peal includes a request for an informal after the appeal is filed, the presiding hearing, as defined in section 201(y) of officer shall, within 5 working days, the act, the appellant shall request ei- hold the hearing and render a decision ther that a hearing be held within 5 affirming or revoking the detention. working days after the appeal is filed (6) If the appellant requests a reguor that the hearing be held at a later latory hearing and requests that the date, which shall not be later than 20 hearing be held at a date later than