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within 5 working days after the appeal other responsible district office offiis filed, but not later than 20 calendar cial, of their new location. The devices days after receipt of a detention order, put in final form shall not be moved the presiding officer shall hold the further without FDA approval. hearing at a date agreed upon by FDA (3) The FDA representative who and the appellant. The presiding officer issued the detention order, or another shall decide whether to affirm or re- responsible district office official, may voke the detention within 5 working approve, in writing, the movement of days after the conclusion of the hear- detained devices for any of the foling. The detention period extends to lowing purposes: the date of the decision even if the 5- (i) To prevent interference with an working-day period for making the de- establishment's operations or harm to cision extends beyond the otherwise the devices. applicable 20-calendar-day or 30-cal- (ii) To destroy the devices. endar-day detention period.
(iii) To bring the devices into compli(7) If the appellant appeals the deten- ance. tion order but does not request a regu- (iv) For any other purpose that the latory hearing, the presiding officer FDA representative who issued the deshall render a decision on the appeal tention order, or other responsible disaffirming or revoking the detention trict office official, believes is approwithin 5 working days after the filing priate in the case. of the appeal.
(4) If an FDA representative approves (8) If the presiding officer affirms a the movement of detained devices detention order, the devices continue under paragraph (h)(3) of this section, to be detained until FDA terminates the detained devices shall remain segthe detention under paragraph (j) of regated from other devices and the perthis section or the detention period ex- son responsible for their movement pires, whichever occurs first.
shall immediately orally notify the of(9) If the presiding officer revokes a ficial who approved the movement of detention order, FDA shall terminate the devices, or another responsible the detention under paragraph (j) of FDA district office official, of the new this section.
location of the detained devices. (h)(1) Movement of detained devices. (5) Unless otherwise permitted by the Except as provided in this paragraph, FDA representative who is notified of, no person shall move detained devices or who approves, the movement of dewithin or from the place where they vices under this paragraph, the rehave been ordered detained until FDA quired tags shall accompany the determinates the detention under para vices during and after movement and graph (j) of this section or the deten- shall remain with the devices until tion period expires, whichever occurs FDA terminates the detention or the first.
detention period expires, whichever oc(2) If detained devices are not in final curs first. form for shipment, the manufacturer (i) Actions involving adulterated or mismay move them within the establish branded devices. If FDA determines that ment where they are detained to com- the detained devices, including any plete the work needed to put them in that have been put in final form, are final form. As soon as the devices are adulterated or misbranded, or both, it moved for this purpose, the individual may initiate legal action against the responsible for their movement shall devices or the responsible individuals, orally notify the FDA representative or both, or request that the devices be who issued the detention order, or an- destroyed or otherwise brought into other responsible district office offi compliance with the act under FDA's cial, of the movement of the devices. supervision. As soon as the devices are put in final (j) Detention termination. If FDA deform, they shall be segregated from cides to terminate a detention or when other devices, and the individual re- the detention period expires, whichever sponsible for their movement shall occurs first, an FDA representative auorally notify the FDA representative thorized to terminate a detention will who issued the detention order, or an 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)
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
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
Subpart E-Other Exemptions 801.150 Medical devices; processing, labeling, or repacking.
Subparts F-G [Reserved]
Subpart H-Special Requirements for (d) The statement of the place of Specific Devices
business shall include the street ad
dress, city, State, and Zip Code; how801.405 Labeling of articles intended for lay
ever, the street address may be omitted use in the repairing and/or refitting of dentures.
if it is shown in a current city direc801.410 Use of impact-resistant lenses in
tory or telephone directory. The reeyeglasses and sunglasses.
quirement for inclusion of the ZIP 801.415 Maximum acceptable level of ozone. Code shall apply only to consumer 800.417 Chlorofluorocarbon propellants.
commodity labels developed or revised 801.420 Hearing aid devices; professional and after the effective date of this section. patient labeling.
In the case of nonconsumer packages, 801.421 Hearing aid devices; conditions for
the ZIP Code shall appear on either the sale.
label or the labeling (including the in801.430 User labeling for menstrual tampons.
voice). 801.433 Warning statements for prescription
(e) If a person manufactures, packs, and restricted device products containing or distributes a device at a place other or manufactured
with than his principal place of business, the chlorofluorocarbons or other ozone-de label may state the principal place of pleting substances.
business in lieu of the actual place 801.435 User labeling for latex condoms.
where such device was manufactured or 801.437 User labeling for devices that contain natural rubber.
packed or is to be distributed, unless
such statement would be misleading. AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
8801.4 Meaning of intended uses. SOURCE: 41 FR 6896, Feb. 13, 1976, unless The words intended uses or words of otherwise noted.
similar import in $8 801.5, 801.119, and
801.122 refer to the objective intent of Subpart A-General Labeling the persons legally responsible for the Provisions
labeling of devices. The intent is deter
mined by such persons' expressions or $ 801.1 Medical devices; name and may be shown by the circumstances place of business of manufacturer,
surrounding the distribution of the arpacker or distributor.
ticle. This objective intent may, for ex(a) The label of a device in package ample, be shown by labeling claims, adform shall specify conspicuously the vertising matter, or oral or written name and place of business of the man- statements by such persons or their ufacturer, packer, or distributor.
representatives. It may be shown by (b) The requirement for declaration the circumstances that the article is, of the name of the manufacturer, pack with the knowledge of such persons or er, or distributor shall be deemed to be their representatives, offered and used satisfied, in the case of a corporation, for a purpose for which it is neither laonly by the actual corporate name beled nor advertised. The intended uses which may be preceded or followed by of an article may change after it has the name of the particular division of been introduced into interstate comthe corporation. Abbreviations for merce by its manufacturer. If, for ex"Company," "Incorporated," etc., may ample, a packer, distributor, or seller be used and "The” may be omitted. In intends an article for different uses the case of an individual, partnership, than those intended by the person from or association, the name under which whom he received the devices, such the business is conducted shall be used. packer, distributor, or seller is re
(C) Where a device is not manufac- quired to supply adequate labeling in tured by the person whose name ap- accordance with the new intended uses. pears on the label, the name shall be But if a manufacturer knows, or has qualified by a phrase that reveals the knowledge of facts that would give him connection such person has with such notice that a device introduced into device; such as, “Manufactured for interstate commerce by him is to be ”, “Distributed by
", or used for conditions, purposes, or uses any other wording that expresses the other than the ones for which he offers facts.
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.
8 801.5 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, or 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.
$801.15 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,
8801.6 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 cos metic.
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) 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
nearly cylindrical container, 40 percent thereon in the foreign language.
of the product of the height of the con(3) If the labeling contains any rep
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 language.
sents an obvious "principal display
panel" such as the top of a triangular 8801.16 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 examments 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