Lapas attēli
PDF
ePub

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.

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

(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)

PART 801-LABELING

or

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, 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 of impact-resistant lenses in

eyeglasses and sunglasses. 801.415 Maximum acceptable level of ozone. 800.41% 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.

quirement for inclusion of the ZIF 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.

(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 re

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

$801.5 Medical devices; adequate di- ness required by section 502(c) of the rections for use.

act by reason, among other reasons, of: Adequate directions for use means di

(1) The failure of such word, staterections under which the layman can

ment, or information to appear on the use a device safely and for the purposes

part or panel of the label which is prefor which it is intended. Section 801.4 sented or displayed under customary defines intended use. Directions for use conditions of purchase; may be inadequate because, among (2) The failure of such word, stateother reasons, of omission, in whole or ment, or information to appear on two in part, or incorrect specification of: or more parts or panels of the label,

(a) Statements of all conditions, pur- each of which has sufficient space poses, or uses for which such device is therefor, and each of which is so deintended, including conditions, pur- signed as to render it likely to be, poses, or uses for which it is prescribed, under customary conditions of purrecommended, or suggested in its oral, chase, the part or panel displayed; written, printed, or graphic adver- (3) The failure of the label to extend tising, and conditions, purposes, or

over the area of the container or packuses for which the device is commonly age available for such extension, so as used; except that such statements shall to provide sufficient label space for the not refer to conditions, uses, or pur- prominent placing of such word, stateposes for which the device can be safely ment, or information; used only under the supervision of a (4) Insufficiency of label space for the practitioner licensed by law and for

prominent placing of such word, statewhich it is advertised solely to such

ment, or information, resulting from practitioner.

the use of label space for any word, (b) Quantity of dose, including usual

statement, design, or device which is quantities for each of the uses for

not required by or under authority of which it is intended and usual quan

the act to appear on the label; tities for persons of different ages and

(5) Insufficiency of label space for the different physical conditions.

placing of such word, statement, or in(c) Frequency of administration or

formation, resulting from the use of application.

label space to give materially greater (d) Duration of administration or ap

conspicuousness to any other word, plication.

statement, or information, or to any (e) Time of administration or appli

design or device; or cation, in relation to time of meals,

(6) Smallness or style of type in time of onset of symptoms, or other

which such word, statement, or infortime factors.

mation appears, insufficient back(f) Route or method of administration or application.

ground contrast, obscuring designs or (g) Preparation for use, i.e., adjust

vignettes, or crowding with other writment of temperature, or other manipu

ten, printed, or graphic matter. lation or process.

(b) No exemption depending on insuf

ficiency of label space, as prescribed in $ 801.6 Medical devices; misleading regulations promulgated under section statements.

502(b) of the act, shall apply if such inAmong representations in the label- sufficiency is caused by: ing of a device which render such de

(1) The use of label space for any

word, statement, design, or vice misbranded is a false or mis

device leading representation with respect to which is not required by or under auanother device or a drug or food or cos

thority of the act to appear on the metic.

label;

(2) The use of label space to give 8801.15 Medical devices; prominence greater conspicuousness to any word, of required label statements.

statement, or other information than (a) A word, statement, or other infor- is required by section 502(c) of the act; mation required by or under authority or of the act to appear on the label may (3) The use of label space for any replack that prominence and conspicuous- resentation in a foreign language.

(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.

(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.

(3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language. 8801.16 Medical devices; Spanish-lan

guage version of certain required

statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under $ 801.15(c).

on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the prin

ipal display pa which area shall be:

(a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side;

(b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; and

(c) In the case of any other shape of container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious "principal display panel" such as the top of a triangular or circular package, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

Subpart B (Reserved]

Subpart C-Labeling Require

ments for Over-the-counter Devices

$ 801.60 Principal display panel.

The term principal display panel, as it applies to over-the-counter devices in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated

$ 801.61 Statement of identity.

(a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity.

(b) Such statement of identity shall be in terms of the common name of the device followed by an accurate statement of the principal intended action(s) of the device. Such statement shall be placed in direct conjunction with the most prominent display of the name and shall employ terms descriptive of the principal intended action(s). The indications for use shall be included in the directions for use of the device, as required by section 502(f)(1)

« iepriekšējāTurpināt »