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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 2-inch by 15-inch (clear) plastic cylinder with a hook on one end and a mark scored 11⁄2 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 11⁄2 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 12-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:

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(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 chapter, with certain exceptions described in paragraph (g)(3) of this section; and (xi) the location and telephone number of the FDA district office and the name of the FDA District Director.

(e) Approval of detention order. A detention order, before issuance, shall be approved by the FDA District Director in whose district the devices are located. If prior written approval is not feasible, prior oral approval shall be obtained and confirmed by written memorandum within FDA as soon as possible.

(f) Labeling or marking a detained device. An FDA representative issuing a detention order under paragraph (d) of this section shall label or mark the devices with official FDA tags that include the following information:

(1) A statement that the devices are detained by the United States Government in accordance with section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)).

(2) A statement that the devices shall not be used, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative, except as authorized in paragraph (h) of this section.

(3) A statement that the violation of a detention order or the removal or alteration of the tag is punishable by fine or imprisonment or both (section 303 of the act, 21 U.S.C. 333).

(4) The detention order number, the date and hour of the detention order, the detention period, and the name of the FDA representative who issued the detention order.

(g) Appeal of a detention order. (1) A person who would be entitled to claim the devices, if seized, may appeal a detention order. Any appeal shall be submitted in writing to the FDA District Director in whose district the devices are located within 5 working days of receipt of a detention order. If the appeal includes a request for an informal hearing, as defined in section 201(y) of the act, the appellant shall request either that a hearing be held within 5 working days after the appeal is filed or that the hearing be held at a later date, which shall not be later than 20

calendar days after receipt of a detention order.

(2) The appellant of a detention order shall state the ownership or proprietary interest the appellant has in the detained devices. If the detained devices are located at a place other than an establishment owned or operated by the appellant, the appellant shall include documents showing that the appellant would have legitimate authority to claim the devices if seized.

(3) Any informal hearing on an appeal of a detention order shall be conducted as a regulatory hearing pursuant to regulation in accordance with part 16 of this chapter, except that:

(i) The detention order under paragraph (d) of this section, rather than the notice under §16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under §16.80(a) of this chapter.

(ii) A request for a hearing under this section should be addressed to the FDA District Director.

(iii) The last sentence of §16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this section.

(iv) Paragraph (g)(4) of this section, rather than §16.42(a) of this chapter, describes the FDA employees, i.e., regional food and drug directors, who preside at hearings under this section.

(4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also shall decide the appeal, shall be a regional food and drug director (i.e., a director of an FDA regional office listed in §5.115 of this chapter) who is permitted by §16.42(a) of this chapter to preside over the hearing.

(5) If the appellant requests a regulatory hearing and requests that the hearing be held within 5 working days after the appeal is filed, the presiding officer shall, within 5 working days, hold the hearing and render a decision affirming or revoking the detention.

(6) If the appellant requests a regulatory hearing and requests that the hearing be held at a date later than

within 5 working days after the appeal is filed, but not later than 20 calendar days after receipt of a detention order, the presiding officer shall hold the hearing at a date agreed upon by FDA and the appellant. The presiding officer shall decide whether to affirm or revoke the detention within 5 working days after the conclusion of the hearing. The detention period extends to the date of the decision even if the 5working-day period for making the decision extends beyond the otherwise applicable 20-calendar-day or 30-calendar-day detention period.

(7) If the appellant appeals the detention order but does not request a regulatory hearing, the presiding officer shall render a decision on the appeal affirming or revoking the detention within 5 working days after the filing of the appeal.

(8) If the presiding officer affirms a detention order, the devices continue to be detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first.

(9) If the presiding officer revokes a detention order, FDA shall terminate the detention under paragraph (j) of this section.

(h)(1) Movement of detained devices. Except as provided in this paragraph, no person shall move detained devices within or from the place where they have been ordered detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first.

(2) If detained devices are not in final form for shipment, the manufacturer may move them within the establishment where they are detained to complete the work needed to put them in final form. As soon as the devices are moved for this purpose, the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible district office official, of the movement of the devices. As soon as the devices are put in final form, they shall be segregated from other devices, and the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or an

other responsible district office official, of their new location. The devices put in final form shall not be moved further without FDA approval.

(3) The FDA representative who issued the detention order, or another responsible district office official, may approve, in writing, the movement of detained devices for any of the following purposes:

(i) To prevent interference with an establishment's operations or harm to the devices.

(ii) To destroy the devices.

(iii) To bring the devices into compli

ance.

(iv) For any other purpose that the FDA representative who issued the detention order, or other responsible district office official, believes is appropriate in the case.

(4) If an FDA representative approves the movement of detained devices under paragraph (h)(3) of this section, the detained devices shall remain segregated from other devices and the person responsible for their movement shall immediately orally notify the official who approved the movement of the devices, or another responsible FDA district office official, of the new location of the detained devices.

(5) Unless otherwise permitted by the FDA representative who is notified of, or who approves, the movement of devices under this paragraph, the required tags shall accompany the devices during and after movement and shall remain with the devices until FDA terminates the detention or the detention period expires, whichever occurs first.

(i) Actions involving adulterated or misbranded devices. If FDA determines that the detained devices, including any that have been put in final form, are adulterated or misbranded, or both, it may initiate legal action against the devices or the responsible individuals, or both, or request that the devices be destroyed or otherwise brought into compliance with the act under FDA's supervision.

(j) Detention termination. If FDA decides to terminate a detention or when the detention period expires, whichever occurs first, an FDA representative authorized to terminate a detention will issue a detention termination notice

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