[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR800.55]

[Page 10-13]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 800--GENERAL--Table of Contents
 
           Subpart C--Administrative Practices and Procedures
 
Sec. 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

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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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 5.115 of this chapter) who is permitted by Sec. 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

[[Page 12]]

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 5-
working-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 another 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

[[Page 13]]

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 (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]