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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 compliance.

(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 (e.g., the good manufacturing practice regulation in part 820 of this chapter).

(44 FR 13239, Mar. 9, 1979, as amended at 49 FR 3174, Jan. 26, 1984; 69 FR 17292, Apr. 2, 2004]

PART 801-LABELING

Subpart A-General Labeling Provisions

Sec. 801.1 Medical devices; name and place of

business of manufacturer, packer or dis

tributor. 801.4 Meaning of intended uses. 801.5 Medical devices; adequate directions

for use. 801.6 Medical devices; misleading state

ments. 801.15 Medical devices; prominence of re

quired label statements. 801.16 Medical devices; Spanish-language

version of certain required statements.

Subpart B [Reserved)

Subpart C-Labeling Requirements for

Over-the-counter Devices

releasing the devices to any person who received the original detention order or that person's representative and will remove, or authorize in writing the removal of, the required labels or tags.

(k) Recordkeeping requirements. (1) After issuance of a detention order under paragraph (d) of this section, the owner, operator, or agent is charge of any factory, warehouse, other establishment, or consulting laboratory where detained devices are manufactured, processed, packed, or held shall have, or establish, and maintain adequate records relating to how the detained devices may have become adulterated or misbranded, records on any distribution of the devices before and after the detention period, records on the correlation of any in-process detained devices that are put in final form under paragraph (h) of this section to the completed devices, records of any changes in, or processing of, the devices permitted under the detention order, and records of any other movement under paragraph (h) of this section. Records required under this paragraph shall be provided to the FDA on request for review and copying. Any FDA request for access to records required under this paragraph shall be made at a reasonable time, shall state the reason or purpose for the request, and shall identify to the fullest extent practicable the information or type of information sought in the records to which access is requested.

(2) Records required under this paragraph shall be maintained for a maximum period of 2 years after the issuance of the detention order or for such other shorter period as FDA directs. When FDA terminates the detention or when the detention period expires, whichever occurs first, FDA will advise all persons required under this paragraph to keep records concerning that detention whether further recordkeeping is required for the remainder of the 2-year, or shorter, period. FDA ordinarily will not require further recordkeeping if the agency determines that the devices are not adulterated or misbranded or that recordkeeping is not necessary to protect the public health, unless the records are required under other regulations in this chapter

801.60 Principal display panel. 801.61 Statement of identity. 801.62 Declaration of net quantity of con

tents. 801.63 Medical devices; warning statements

for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.

Subpart D-Exemptions From Adequate

Directions for Use

801.109 Prescription devices. 801.110 Retail exemption for prescription de

vices. 801.116 Medical devices having commonly

known directions. 801.119 In vitro diagnostic products. 801.122 Medical devices for processing, re

packing, or manufacturing. 801.125 Medical devices for use in teaching,

law enforcement, research, and analysis. 801.127 Medical devices; expiration of ex

emptions.

Subpart E-Other Exemptions

801.150 Medical devices; processing, label

ing, or repacking.

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. 801.410 Use impact-resistant lenses in

eyeglasses and sunglasses. 801.415 Maximum acceptable level of ozone. 800.417 Chlorofluorocarbon propellants. 801.420 Hearing aid devices; professional and

patient labeling. 801.421 Hearing aid devices; conditions for

sale. 801.430 User labeling for menstrual tam

pons. 801.433 Warning statements for prescription and restricted device products containing manufactured

with chlorofluorocarbons or other ozone-de

pleting substances. 801.435 User labeling for latex condoms. 801.437 User labeling for devices that con

tain natural rubber. AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

SOURCE: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).

(e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading.

or

Subpart A-General Labeling

Provisions

name

$ 801.1 Medical devices;

and place of business of manufacturer,

packer or distributor. (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company,” "Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ", "Distributed by

", or any other wording that expresses the facts.

$ 801.4 Meaning of intended uses.

The words intended uses or words of similar import in $$ 801.5, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate

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labeling for such a device which accords with such other uses to which the article is to be put.

or

8801.5 Medical devices; adequate di

rections for use. Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of:

(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.

(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.

(c) Frequency of administration or application.

(d) Duration of administration or application.

(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.

(f) Route or method of administration or application.

(g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process. $ 801.6 Medical devices; misleading

statements. Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.

$ 801.15 Medical devices; prominence

of required label statements. (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:

(1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

(2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;

(3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;

(4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(5) Insufficiency of label space for the placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or

(6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.

(b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502(b) of the act, shall apply if such insufficiency is caused by:

(1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(2) The use of label space to give greater conspicuousness to any word,

statement, or other information than out obscuring designs, vignettes, or is required by section 502(c) of the act; crowding. Where packages bear alteror

nate principal display panels, informa(3) The use of label space for any rep- tion required to be placed on the prinresentation in a foreign language.

cipal display panel shall be duplicated (c)(1) All words, statements, and on each principal display panel. For other information required by or under the purpose of obtaining uniform type authority of the act to appear on the size in declaring the quantity of conlabel or labeling shall appear thereon tents for all packages of substantially in the English language: Provided, how- the same size, the term area of the prinever, That in the case of articles dis

cipal display panel means the area of tributed solely in the Commonwealth

the side or surface that bears the prinof Puerto Rico or in a Territory where cipal display panel, which area shall the predominant language is one other be: than English, the predominant lan

(a) In the case of a rectangular packguage may be substituted for English.

age where one entire side properly can (2) If the label contains any represen

be considered to be the principal distation in a foreign language, all words,

play panel side, the product of the statements, and other information re

height times the width of that side; quired by or under authority of the act

(b) In the case of a cylindrical or to appear on the label shall appear thereon in the foreign language.

nearly cylindrical container, 40 percent (3) If the labeling contains any rep

of the product of the height of the con

tainer times the circumference; and resentation in a foreign language, all words, statements, and other informa

(c) In the case of any other shape of tion required by or under authority of

container, 40 percent of the total surthe act to appear on the label or label

face of the container: Provided, howing shall appear on the labeling in the

ever, That where such container preforeign nguage.

sents an obvious “principal display

panel" such as the top of a triangular $ 801.16 Medical devices; Spanish-lan- or circular package, the area shall con

guage version of certain required sist of the entire top surface. statements.

In determining the area of the prinIf devices restricted to prescription cipal display panel, exclude tops, botuse only are labeled solely in Spanish toms, flanges at the tops and bottoms for distribution in the Commonwealth

of cans, and shoulders and necks of botof Puerto Rico where Spanish is the

tles or jars. In the case of cylindrical predominant language, such labeling is or nearly cylindrical containers, inforauthorized under $ 801.15(c).

mation required by this part to appear

on the principal display panel shall apSubpart B [Reserved]

pear within that 40 percent of the cir

cumference which is most likely to be Subpart C-Labeling Require displayed, presented, shown, or exam

ments for Over-the-Counter ined under customary conditions of disDevices

play for retail sale. $ 801.60 Principal display panel.

8801.61 Statement of identity. The term principal display panel, as it (a) The principal display panel of an applies to over-the-counter devices in over-the-counter device

in package package form and as used in this part, form shall bear as one of its principal means the part of a label that is most features a statement of the identity of likely to be displayed, presented, the commodity. shown, or examined under customary (b) Such statement of identity shall conditions of display for retail sale. be in terms of the common name of the The principal display panel shall be device followed by an accurate statelarge enough to accommodate all the ment of the principal intended acmandatory label information required tion(s) of the device. Such statement to be placed thereon by this part with shall be placed in direct conjunction clarity and conspicuousness and with- with the most prominent display of the

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