5-5 - ADMINISTRATIVE DETENTION OF DEVICES
5-5-1 - Purpose
5-5-2 - Detention Of Devices
5-5-3 - Appeal Of A Detention Order
5-5-4 - Informal Hearing On Appeal Of A Detention Order
5-5-5 - Requirements After A Hearing On Appeal Of A Detention Order
5-5 - ADMINISTRATIVE DETENTION OF DEVICES
5-5-1 - Purpose
This section provides the procedures and defines responsibilities for the Administrative Detention of Devices.
5-5-2 - Detention Of Devices
Section 304(g) of the Act authorizes the FDA to detain devices intended for human
use for a period of up to 30 calendar days if, during an inspection, the FDA
has reason to believe the devices are adulterated or misbranded. The intent
of administrative detention is to protect the public by preventing distribution
or use of violative devices until FDA has had time to consider the appropriate
action to take and, where appropriate, to initiate a regulatory action. The
action of choice, in most cases, is a seizure. Detention of devices requires
prior approval from the district director in which the devices are located
and the concurrence of the appropriate center‘s director for compliance.
Any person entitled to claim the devices, if seizure occurred, may appeal the
detention and may request a hearing on the appeal. The decision to affirm or
revoke the detention must occur within five (5) working days of receipt of the
appeal if there is no request for a hearing or if the request for a hearing is
within 5 working days after filing the appeal. If requesting the hearing for
a date more than 5 working days after receiving the appeal, the decision must
occur within 5 working days after the conclusion of the hearing.
The Center for Biologics Evaluation and Research (CBER), and the Center for Devices
and Radiological Health (CDRH) are responsible for administering the medical
The regulatory authority for administrative detention and associated operations
appears in Sections 304(g) and 201(x) of the Act, and in 21 CFR 800.55, 21
CFR Part 16, 21 CFR 5.47, and 21 CFR 10.19. The IOM Chapter 2, Subchapter 2.7,
Detention Activities contains the instructions for implementing the detention
- Detention Policy
This enforcement tool should be
considered when there is likelihood that the device(s)
will be moved or distributed before seizure can be accomplished. Whenever
possible, state embargoes should be used instead of administrative detention
because the latter can be resource intensive.
If the district director concludes
that the person in possession of the device(s) will
voluntarily hold the product, will provide assurance that integrity and
security will be maintained over the devices on hand, and agrees to correct the
violation(s) prior to shipment, there is no need to detain the goods.
At a minimum, prior to approving the
detention order, the district director contacts the senior compliance official
in the appropriate center to ensure that the Agency supports an administrative
detention based on the violations observed. This ensures that the Agency
considers recent policy developments or changes not yet communicated
to the field. In addition, the district
director notifies headquarters of the impending seizure recommendation.
Director, Office of Compliance (HFZ-300), CDRH (301) 594-4692 or, if a biological device:
Director, Office of Compliance and Biologics Quality (HFM-600), CBER (301) 827-6190.
Concurrence is by telephone. The field or headquarters does not require written concurrence except for cause, for example, for issues of science, policy, or law involving precedent or questionable facts.
- Approval of Detention Order By The District Director
The district director approves a detention order, before issuance, either
orally or in writing. If the approval is oral, it should be placed
in writing as soon as possible.
- Detention Order Issuance
An investigator or other authorized agent signs the order. Issue the order
in writing to the owner, operator, agent, or other responsible person in
charge of the place where the device is located.
When issuing the order, the FDA investigator informs the owner, agent
or other responsible person that they have the opportunity to appeal
and have a hearing on the detention as noted on the order. If the order
is not issued to the owner or agent of the owner of the device, then
the district sends, as soon as possible, copies of the detention order
and 21 CFR 800.55(g)(1)& (2)
to the owner, via certified mail return receipt requested.
- Form of Order
Issue the detention order on Form FDA 2289 Detention Notice.
Section 22.214.171.124 of the IOM contains instructions for completion
of the form.
The detention order frames the issues for appeal or informal hearing, which may result from the detention. Therefore, the information on the order concerning the reason for detention is very important.
There is no requirement that the order include all of the reasons for
believing that the product is adulterated or misbranded. Only list
the more significant violations. However, if a violation is not identified
in the order, it may not be relied on to support the detention. State
the charge in the order in factual, non-statutory language. For example,
if the investigator finds a sterile, individually packaged syringe
with holes along the seams of the packaging, black greasy spots on
the needle, and the label lacks the Zip Code of the manufacturer, describe
the apparent violation in the reason for detention as "there is reason
to believe the device is:
Adulterated per Section 501(a)(2)(A) of the Act because there are holes in the package and black spots on the needles. The firm prepared, packed, or held the product under insanitary conditions whereby it may have been rendered injurious to health.
Misbranded per Section 502(a) because the label states that it is sterile
and the integrity of the package is compromised by holes. The labeling
is false or misleading.”
Note: Use a "continuation sheet" if all of the charges will not fit
on the form.
Note: Charges used in the detention order do not necessarily limit the charges that may be identified in a subsequent complaint filed in court.
- Length of Detention
According to statute, a detention is for 20 calendar days unless the district believes that additional time is required to accomplish a legal action. In such cases, the detention is for 30 calendar days at the time of issuing the order. When extending a detention from 20 to 30 days, issue another detention order and place new tags on the devices.
By statute, the detention cannot last for longer than 30 calendar days.
- Movement, Use, etc. of Detained Devices
Except as noted below, without the written permission of the Agency, detained devices cannot be moved, used, altered, or tampered with in any manner. Therefore, if possible, the investigator should segregate the detained devices from other devices or products at the time of the detention so they remain undisturbed.
With the approval of the district director, the investigator who detained the devices or any other responsible district official may authorize, in writing, the movement of detained material. Whoever moves the devices must immediately notify (orally) the authorizing official of the new location.
The only exception to the prohibition on movement without written permission is when the goods are not in final form for shipment and the manufacturer wants to complete work on them. The manufacturer may move them within the facility where detained to complete manufacture, but must orally notify FDA of the movement as it occurs. When completing manufacturing, the manufacturer must immediately segregate the detained devices from other products and orally notify FDA of their new location.
However, the manufacturer may not move the devices from the establishment without prior written approval of the district director as referenced above.
Note: 21 CFR 800.55(h)(2) prohibits further movement even within the establishment without FDA approval.
- Legal Actions Against Detained Devices
The district should expedite the preparation and processing of a seizure recommendation involving the detained devices. The recommendation should be flagged to indicate that it involves detained devices and show the date the detention expires, and should be forwarded to the responsible center by overnight delivery service.
The center compliance office, ORA, and OCC should likewise expedite their reviews to accomplish the legal action prior to expiration of the detention. If the detention expires prior to the seizure, the person who owns the devices may move the goods and the violative product may find its way into commercial distribution.
The district is responsible for monitoring the length of the detention and the progress of the recommendation. If a 20-day detention expires prior to accomplishing the legal action, the district should extend the detention for an additional 10 days.
The district is responsible for coordination with the U.S. Attorney's office and the Marshal's Service, ensuring prompt filing of the complaint, and seizure of the goods.
The district is also responsible for immediately providing oral notice to the appropriate center compliance office, OCC, and the presiding officer of the accomplishment of the seizure or of any appeal of a detention order.
- Recordkeeping Requirements
At the time of issuance of a detention order, or as soon as possible thereafter, the district informs the owner, operator, or agent in charge of the establishment where the devices are detained of their responsibility to establish and maintain records as required by 21 CFR 800.55(k).
- Termination of Detention Orders
- The reasons for termination of Detention orders:
- FDA determines that the device(s) is (are) not violative.
- FDA approves voluntary destruction or compliance by reconditioning
or other means (e.g., relabeling).
- FDA revokes the detention on appeal.
- FDA accomplishes a regulatory action against the product. Actual
seizure or entry of TRO or an order by consent or otherwise of
preliminary injunction is necessary. The filing of a complaint
does not necessarily terminate a detention order.
- The detention period expires.
The district director, within whose district the devices are detained, must approve termination of detention orders. Approval is oral or written, and if oral, confirmation is in writing. The district issues the Detention Termination Notice (Form FDA 2291) to the person(s) who received the Detention Notice, or his representative and, if movement of the devices occurred prior to the termination, to the person possessing the devices. Issuance of the notice is in person or by mail. If the termination notice is issued by mail, request that the Detention Tags (Form FDA 2290) be returned. If the termination notice is issued in person, see IOM 126.96.36.199 for instructions. Per 21 CFR 800.55(k)(2), the district issues a statement advising the owners, operators, or agents in charge to keep the records concerning the detention for the remainder of the two year period from the date of detention or such shorter period as FDA directs.
- Responsibilities for Issuing and Terminating Detention Orders
- District Responsibilities As referenced above, the district is responsible for:
- Ensuring support from the senior compliance official of the appropriate center before issuing a detention order.
- Issuing the detention order.
- Notifying the Director of the Division of Compliance Management and Operations (DCMO) by phone of the detention and supplying that person with a copy of the detention order by the most expeditious means available (fax, express mail, etc.) immediately after issuance.
- Approving and monitoring the movement of detained devices.
- Notifying the regional director that the district issued a detention order.
NOTE: Keep the Regional Food and Drug Director (RFDD) insulated from detention proceedings after the detention is in place in order to avoid even the appearance of bias or prejudice.
- Pursuing the follow-up legal action as discussed under the heading, "Legal Actions Against Detained Devices."
- Center Compliance Office Responsibilities
District contact with the center, for concurrence, is a routine procedure. If the director of compliance for the center will not support a proposed detention, do not issue the order. Communication of the director’s decision to the district is by phone, e-mail, or other expedited communication. Generally, a formal submission of documents supporting detention is not necessary.
The compliance office will quickly review any information provided by the district, through DCMO, alert the district, DCMO, and OCC of any problems, and forward to the district all requested documents. The compliance office will provide expert witnesses and other support, as appropriate.
- Office of Chief Counsel Responsibilities
OCC will quickly review any information provided by the district, and through DCMO, alert the district, the center office, and DCMO, of any problems, prior to the detention being put in place.
The Deputy CC for Litigation or the Deputy CC for Regulations and Hearings shall make staff assignments in OCC and notify the center and DCMO of the attorney assigned to the case. OCC will begin preliminary preparations for any appeal. OCC will determine whether the district and the RFDD require legal counsel.
- DCMO Responsibilities
Upon notification that a detention has been affected or a subsequent appeal received by the district:
DCMO will immediately notify the center compliance office and OCC, and deliver to them copies of the detention order, request for hearing, and other supporting documents. DCMO will coordinate the detention to ensure that all Agency and OCC components receive notification and prepare for a hearing in a timely manner.
- RFDD Responsibilities
The RFDD must insulate himself/herself, after the detention is in place, from all aspects of a detention except those relating to his/her responsibilities as a presiding officer. Responsibilities at that time are in the next section, "Appeal of a Detention Order."
5-5-3 - Appeal Of A Detention Order
- General Information
Section 304(g) of the Act permits anyone who is entitled to claim the goods, if seized, to appeal a detention order.
If appealing the detention, Section 304(g) requires that the Agency afford the appellant with an opportunity for an informal hearing. If the appellant does not request an informal hearing, the decision to affirm or revoke the detention must be rendered within 5 working days after the filing of the appeal. The appellant may request the holding of an informal hearing either within 5 working days after filing the appeal or at a later date, but not later than 20 calendar days after receipt of the detention order (21 CFR 800.55(g)(1)). If the appellant requests a hearing within 5 working days after filing the appeal, the presiding officer holds the hearing and renders a decision within 5 working days of the filing of the appeal. In the event of a request for a delayed hearing, the scheduling of the hearing must occur after the fifth working day following the appeal, and a decision must be issued within 5 working days of the hearing's conclusion.
Regardless of the scheduling of the hearing, there is no extension past the 30-calendar day detention period without the consent of the appellant. (The provision for extension of the detention found in 21 CFR 800.55(g)(6) is incorrect and should not be followed.)
- Time to Appeal
The regulations allow an appellant 5 working days from the receipt of the detention order (which also serves as a notice of opportunity for a hearing) to appeal the detention, with or without a request for an informal hearing. The appeal must be in writing, must be addressed to the district director of the district office within whose area the goods are detained, and must contain a statement asserting that interest (e.g., ownership) in the detained goods would qualify the appellant to claim the goods if they were to be seized. The postmark on the appeal letter will determine the date of the appeal.
The district director will allow 1 day of additional time for the receipt of an appeal request. Allow additional time if the appellant shows that it was impossible to appeal earlier.
- Presiding and Deciding Official
The RFDD for the region where the district is located and in which the goods were detained must be the presiding and deciding official unless he/she disqualifies him/herself (21 CFR 800.55(g)(4), 21 CFR 16.40 and 16.42, and 21 CFR 5.47). In the event of disqualification, the RFDD will immediately arrange for another RFDD to preside and provide immediate notification of any such change to the district director and the appellant.
Communications Between Parties to the Hearing And the Presiding Officer
Avoid any off-the-record communication between parties to the hearing and the presiding officer. If any such communication occurs, reduce it to writing and make it a part of the record. The presiding officer must supply a copy of any memoranda of such communication, which would affect his or her decision, to the other party, giving them an opportunity to respond (21 CFR 16.44(b)).
The person who originates any written communication between a participant in the hearing and the presiding officer must send a copy of any such communication to all of the participants (21 CFR 16.44(c)).
- Appeal Processing Responsibilities
- District Responsibilities
Preparation for an appeal should begin when the district decides to detain a device(s), in case a hearing is requested within 5 working days of the filing of the appeal.
- When the district receives an appeal, the director:
- Dates and time stamps the appeal, and notifies the appellant of receipt of the appeal. If the appeal does not specify that a hearing is or is not requested, does not demonstrate ownership or proprietary interest as required in 21 CFR 800.55(g)(1) and (2), or does not specify the time period within which to hold a hearing (see “Appeal of a Detention Order- Background"), contact the appellant and clarify this information. Make any declaration of ownership or proprietary interest in writing.
- Orally notifies the RFDD and the Director, DCMO of the appeal immediately and forwards a copy of the appeal to them as soon as possible. Requests assistance of OCC and the appropriate center for completing the next item.
- When the appeal includes a request for a hearing:
- Prepare (1) a general summary of the information that supports the detention and (2) a comprehensive statement of the basis for the action. The Detention Order (notice) may serve as the comprehensive statement only if the reason for detention is described in sufficient detail. See Exhibits 5-14 and 5-15 for an example of a general summary and a comprehensive statement respectively. See Exhibit 5-16 for examples of reasons detailed enough for the FDA 2289 to serve as a comprehensive statement.
- Forward the general summary and comprehensive statement to the appellant (21 CFR 16.24(f) and Section 201(x)(3) of the Act), the RFDD, and any office and OCC representatives to the hearing. Send the documents immediately so that they arrive as soon as possible, but at least 1 day prior to the hearing.
- At least 1 day before the hearing, provide the appellant, the RFDD, and any office and OCC representatives to the hearing, written notice of, or copies of, if they could not reasonably be expected to obtain copies, any published articles or written information to be presented at or relied on at the hearing (21 CFR 16.24 (g)).
- When the appeal does not include a request for a hearing, the district forwards all the information that supports the detention to the RFDD acting as the deciding official. The district includes the referenced general summary and comprehensive statement and any additional information provided by the appellant. It must arrive within sufficient time to be reviewed and for a decision to be rendered within 5 working days after receipt of the appeal.
- Presiding RFDD Responsibility
When notified of an appeal, the RFDD
- If a hearing is requested,
- Orally contact the parties as soon as possible. Depending on the time period within which the appellant requests a hearing, either set a hearing date and time to allow for a decision within 5 working days after the date of receipt of the appeal by the district, or set a hearing date and time later than 5 working days after receipt of the appeal by the district, but not later than 20 calendar days after issuance of the detention order. The hearing normally takes place at the district office where the goods are located.
- Provide all parties with written notification of the time, date, and location of the hearing.
- Provide the appellant with oral and written notification (see form letter as Exhibit 5-17) of the following:
- Notification of those portions of 21 CFR Part 16 that are excluded or modified under 21 CFR 800.55(g)(3) and waived or modified for hearings on appeal of administrative detentions (see "Informal Hearing on Appeal of a Detention Order.")
- Notification that the informal hearing is not a public hearing per 21 CFR 16.60(a), in order to protect investigatory records compiled for law enforcement purposes that are not available for public disclosure under 21 CFR 20.64, or trade secret material under 21 CFR 20.61.
- Notification that the appellant should provide, at the hearing, a brief summary of any lengthy documents for presentation at the hearing (e.g., volumes of computer printouts).
- Notification that if feasible, at least 1 day before the hearing, the appellant should provide the district director written notice of, or a copy of (if the district director could not reasonably be expected to obtain a copy), any published articles or written information for presentation at or relied on at the hearing as required by 21 CFR 16.24(g).
- Notification of the requirements under 21 CFR 16.44(c) (see "Communications Between Parties to the Hearing and the Presiding Officer.")
- If an appeal is made but no hearing is requested, the presiding officer must immediately orally notify the parties to submit information supporting their positions as soon as possible so that the information can be reviewed and a decision reached within 5 working days of the receipt of the appeal. We will accept additional information submitted prior to the decision. The presiding officer orally notifies the appellant of the requirement under 21 CFR 16.44(c) (see "Communications Between Parties to the Hearing and the Presiding Officer.")
When advice of the CC is needed, contact the Deputy CC for Litigation.
5-5-4 - Informal Hearing On Appeal Of A Detention Order
Section 304(g) of the Act states that upon appeal of a detention order, the Agency will afford the appellant with an opportunity for an "informal hearing." Section 201(x) of the Act defines an informal hearing and lists specific provisions. 21 CFR 800.55(g)(3) provides that 21 CFR Part 16, Regulatory Hearing, establishes the procedures for conducting the informal hearing. 21 CFR 16.5 of the regulations advises that Part 16 procedures apply to the extent that they are supplementary to, and not in conflict with, other procedures specified for the hearing. 21 CFR 16.60(h) gives the presiding officer the power to suspend, modify, or waive provisions under Part 16.
- Waivers, Modifications, Etc. To 21 CFR Part 16
21 CFR 800.55(g)(3) waives the following sections of 21 CFR Part 16:
- §16.22(a) concerning the issuance of a separate notice of opportunity for hearing because the detention notice FDA 2289 serves that function under 21 CFR 800.55(g)(3)(i).
- §16.22(b) concerning the forwarding of the appeal to the presiding officer because 21 CFR 800.55 (g)(1) requires sending the appeal to the district director.
- §16.24(e) concerning not permitting the hearing to be held within 2 days of the receipt of the appeal because time constraints cannot allow for such a restriction.
- §16.42(a) regarding those persons who may act as the presiding officer because 21 CFR 800.55(g)(4) only allows RFDDs to be presiding officers.
The presiding officer has the authority to waive, suspend, or modify any of the provisions under Part 16 (21 CFR 10.19 and 21 CFR 16.60(h)). The presiding officer must waive the following other provisions:
FDA waives that part of 21 CFR 16.60(b) which provides that all parties may confront and conduct reasonable cross-examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing. There is an allowance for reasonable questions instead. Reference Congressional intent: House of Representatives Report no. 94-853. Also, see 21 CFR 16.5 and 16.60(h).
- §16.60(f) which requires the hearing officer to make a recommended decision with statement of reasons to the deciding official because the RFDD performs both functions.
- §16.95(b)(1) & (2) which state that the Administrative Record of a Regulatory Hearing (21 CFR 16.80(a)(1)-(5)) is the exclusive record and basis for the decision, are modified as follows: FDA bases the decision, in most cases, on all information presented to the presiding officer prior to or during the hearing. The decision is not to be based on the following information or documents, if they are not received or completed by the presiding officer within the time necessary for the presiding officer to review or complete them prior to making the decision as required by the Act or regulation:
- Information and views submitted to the presiding officer after the hearing are not part of the official record unless the presiding officer permits post-hearing submissions and submittal of information occurs within the period specified by the presiding officer (21 CFR 16.80(a)(2)).
- Any transcript of the hearing (21 CFR 16.80(a)(3)).
- The presiding officer's report of the hearing and comments on the report under 21 CFR 16.60(e) and 16.80(a)(4).
- Responsibilities for the Hearing
- CENTER Responsibilities
The center will provide documents, witnesses, or office representatives for the hearing if requested by the district or the OCC attorney counseling the district.
- Office Of Chief Counsel Responsibilities
OCC will provide for the district and/or the presiding officer, as appropriate, for the hearing.
- District And Presiding RFDD Responsibilities
The section “Conducting the Hearing” includes individual responsibilities of the district and the presiding RFDD.
- Conducting The Hearing – General Procedures/Responsibilities
At the onset, the presiding officer reminds the parties of the modifications to Part 16 that apply and explain the purpose or issue of the hearing. The issue at the hearing is whether FDA had reason to believe the devices were adulterated or misbranded at the time of the detention and as charged in the detention order. The issue is not whether the law has been violated. That question is properly left to the court trial, if one is held.
The FDA representative(s) is present to explain the bases for the detention and answer reasonable questions from the appellant.
The appellant then presents relevant information and reasons why he believes the Agency did not have reason to detain the product.
The FDA representatives may then ask reasonable questions (see Section 201(x)(4) of the Act).
The presiding officer ensures that the material presented and the questions asked are relevant to the issue of the hearing.
The appellant may request a transcript of the hearing. However, the appellant must pay the cost of it and furnish the presiding officer a copy for the record. The Agency can also request a transcript of the hearing and the costs are borne by the government.
If the appellant wishes a copy of the government transcript, he/she may obtain it via a Freedom of Information (FOI) Act request. 21 CFR Part 20 applies to the release of the transcript.
The presiding officer notifies the parties that his decision will not await transcription or correction of the transcripts so ordered.
5-5-5 - Requirements After A Hearing On Appeal Of A Detention Order
- Presiding RFDD Responsibility
- Confirming or Revoking the Detention Order
- Time Period for Rendering Decision
As referenced in "Appeal of a Detention Order - Background," the presiding officer must by order, confirm or revoke the detention order within 5 working days of the receipt of the appeal by the district director, if there is no hearing requested or if the appellant requests a hearing within 5 working days. However, if the appellant requests a hearing later than the referenced 5 working day time frame, but not later than 20 calendar days after issuance of the detention order, then the presiding officer must, by order, confirm or revoke the detention order within 5 working days after the close of the hearing (21 CFR 800.55(g)(5) and (6)). The detention may not be extended past the otherwise applicable 30-day period (see "Appeal of a Detention Order - Background") without the consent of the appellant.
- Basis for Rendering Decision
If the Agency can show that it had a reason to believe that the devices were adulterated or misbranded at the time of the detention under one or more of the charges in the detention order, the presiding officer will affirm the detention order. If not, the presiding officer will revoke the detention order.
- Issuance of the Order
The decision is issued in the form of an order. (See Exhibit 5-18 for model order.) The parties to the appeal should be orally notified of the order immediately. Copies of the order should then be mailed to them via certified mail return receipt requested.
FDA must order the decision rendered on the detention within the above time frames; however, the completion of the written decision and report of the hearing (discussed below) cannot delay the order. Normally, the order is consolidated with the written decision and report of the hearing. However, there are cases when the Agency needs additional time to complete the written decision and report of the hearing. In that case, it is separate from and will shortly follow the order.
- Written Decision and Report of Hearing
The presiding officer must prepare a written decision to include the reasons and basis for his decision (§ 16.95(b)(2)). The written decision must include the report of the hearing required by Section 201(x)(5) of the Act and 21 CFR 16.60(e). All written material submitted during the hearing must be attached to the written decision and report of the hearing (Section 201(x)(5) of the Act and 21 CFR 16.60(e)). Any transcripts of the hearing must be included.
Whenever time permits, the participants will be given the opportunity to review and comment on the written decision and report of the hearing. However, the presiding officer should set a time limit for the participants to comment. (As previously noted, whenever possible, the written decision and report of the hearing should be issued with the order as a single document).
- Administrative Record of the Hearing
The presiding officer must prepare the Administrative Record of the Hearing, which consists of the following items:
File the original Administrative Record of the Hearing with the firm’s official file at the district office after completion of the report. A copy should be forwarded to the center involved for its information. A copy should be maintained in the office of the RFDD that held the hearing.
- The detention order and the appeal.
- All written information and views submitted to the presiding officer in conjunction with the hearing.
- Any transcript of the hearing.
- The presiding officer's written decision, report of the hearing, order, and any comments on the written decision or report of the hearing permitted under Section 201(y) of the Act and 21 CFR 16.60(e).
- All letters and memoranda of meetings and communications between participants and the presiding officer referred to in 21 CFR 16.44(c).
- FOI Requests
21 CFR Part 20 applies to all requests for documents involved in administrative detentions