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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
CDRH FDA Modernization Act of 1997 Page
The Center for Devices and Radiological Health (CDRH) develops and implements national
programs to protect the public health in the fields of medical devices and radiological
health. These programs are intended to assure the safety, effectiveness, and proper
labeling of medical devices; to promote quality in mammographic services; and to control
unnecessary human exposure to potentially hazardous radiation, and to ensure the safe,
efficacious use of such radiation.
The basic framework governing the regulation of medical devices is established in the
Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act. The
Medical Device Amendments were enacted on May 28, 1976. The FFD&C Act was again
amended with respect to the regulation of medical devices by the Safe Medical Devices Act
of 1990 and the Medical Device Amendments of 1992. New provisions governing the export of
FDA regulated products, including medical devices, were established in the FDA Export
Reform and Enhancement Act of 1996. The FFD&C Act was most recently amended by the
Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Signed
into law on November 21, 1997, the Modernization Act contained provisions related to all
products under FDAs jurisdiction. This document summarizes each device-related
section of the Modernization Act in "plain English." It is not intended to be
interpretive or to set forth Agency policy for implementation.
We welcome your comments and requests for further information.
D. Bruce Burlington, M.D. Director Center for Devices and Radiological Health |
The Medical Device Amendments of 1976 mandated the establishment of "an
identifiable office to provide technical and other nonfinancial assistance to
small manufacturers of medical devices to assist them in complying with the
requirements of the FFD&C Act." The Division of Small Manufacturers,
International and Consumer Assistance (DSMICA) in the Office of Communication,
Education, and Radiation Programs was established to meet this requirement.
DSMICA develops educational materials and sponsors workshops and conferences
to provide firms with firsthand working knowledge of medical device requirements
and compliance policies.
This booklet covers the medical device provisions of the Modernization Act, which amends
the FFD&C Act.
For further information, contact the appropriate office within CDRH or call DSMICA at
800.638.2041 or 301.443.6597, FAX 301.443.8818, or Email us at DSMICA@CDRH.FDA.GOV. This document is accessible on the
WWW at http://www.fda.gov/cdrh/modact/modern.html and via the DSMICA Facts section of CDRH
Facts-On-Demand (an automated document retreival system).
Comments on this booklet, related workshops, and other DSMICA activities are always welcome.
John Stigi Director Division of Small Manufacturers, International and Consumer Assistance |
Congress amended the FFD&C Act in an effort to streamline the process of bringing
safe and effective drugs, medical devices, and other therapies to the U.S. market.
With respect to medical devices, the FDA is directed to focus its resources on the
regulation of those devices that pose the greatest risk to the public and those that offer
the most significant benefits. The FDA must base its decisions on clearly defined criteria
and provide for appropriate interaction with the regulated industry. The new legislation
assumes that enhanced collaboration between the FDA and regulated industry will accelerate
the introduction of safe and effective devices to the U.S.
The Modernization Act was signed into law by President Clinton on November 21, 1997. Most
provisions went into effect on February 19, 1998 (90 days from enactment of the
Modernization Act), while some have different effective dates or require implementing
regulations.
This document presents a summary of each device related section of the Modernization Act,
combined under relevant headings, i.e. IDEs, PMAs, 510(k)s. It includes
a brief description of the new provisions, including effective dates, and identifies
applicable Federal Register (FR) documents.
Sections Related to: Investigational Device Exemptions
Section 201 - Changes to Protocols and Devices
1) validity of the data resulting from the study;
2) the risk to benefit ratio relied upon to approve the protocol;
3) the scientific soundness of the study, or
4) the rights, safety or welfare of the human subjects.
Section 201 - Early Collaboration of Data Requirements for Clinical Studies
Sponsors that intend to perform a clinical study of any Class III device or any
implantable device in any class, will be given an opportunity to meet with FDA to discuss
their investigational plan, including the clinical protocol, for the purpose of reaching
an agreement on the investigational plan before they apply for an investigational device
exemption (IDE).
A written request for this meeting from the sponsor to FDA is required. The request shall
include a detailed description of the device, proposed conditions of use and a proposed
investigational plan (including clinical protocol), and, if available, expected
performance of the device. The FDA has 30 days to meet with the sponsor after receipt of
the written request.
An official record will be made of any agreement that is reached between the sponsor and
the FDA. This agreement will be binding and is not subject to change except:
1) with written agreement of the sponsor; or
2) if FDA decides that a substantial scientific issue essential to determining the safety
or effectiveness of the device has been identified following the initial agreement. In
this case, the decision by FDA must be in writing and follow an opportunity for the
sponsor to meet with the Agency to discuss the issue identified.
Effective: February 19, 1998
Section 205 - Meeting on Evidence of Effectiveness for PMAs
Sponsors planning to submit a Premarket Approval Application (PMA) can submit a written
request to FDA for a meeting to determine the type of information (valid scientific
evidence) that is necessary to support the effectiveness of their device.
The request must include a detailed description of the device, proposed conditions of use,
an investigational plan and, if available, information regarding the devices
expected performance. The FDA must meet with the requester and communicate the
Agencys determination of the type of data that will be necessary to demonstrate
effectiveness in writing within 30 days after the meeting. When making this determination,
FDA must determine that the information specified is necessary to provide a reasonable
assurance that the device is effective and must have considered the least burdensome
method of evaluation that is likely to result in approval.
FDAs determination will be binding and not subject to change unless the Agency
determines that the decision could be contrary to the public health.
While the meeting under Section 205 is intended to focus on the type of valid scientific
evidence that will be necessary and the meeting under Section 201 is intended to focus on
the actual protocol, FDA believes the purposes of the meetings can usually most
effectively be accomplished in a single meeting. However, some sponsors may request and
benefit from two separate meetings.
Effective: February 19, 1998
Section 203 - Expanded Humanitarian Device Exemption (HDE)
1) the Agency believes it is necessary to protect public health; or
2) the Agency has reason to believe the criteria for an HDE is not being
met.
Approval of an HDE may not be withdrawn unless the sponsor is given an opportunity
for an informal hearing.
* Section 402 - Expanded Access to Investigational Devices
* This provision also affects other products in addition to medical devices
that are regulated by the FDA. However, any processes or procedures that CDRH
establishes will apply only to medical devices.
1) the licensed physician determines that there is no comparable or satisfactory
alternative treatment and that the risk from use of the device does not
exceed the risk of the disease or condition;
2) the FDA determines there is sufficient evidence of safety and effectiveness
to support the use of the device;
3) the FDA determines that providing the device will not interfere with
clinical investigations to support marketing approval; and
4) the sponsor or investigator submits a protocol to FDA describing the
use of the device in a single patient or in small groups of patients.
1) the use of the device is intended for the diagnosis, monitoring or
treatment of a serious or immediately life-threatening disease or condition;
2) there is no comparable or satisfactory alternative;
3) the device is being clinically evaluated under an approved investigational
device exemption or all clinical investigations to support marketing approval
have been completed;
4) the sponsor is actively pursuing marketing approval;
5) the treatment use will not interfere with the enrollment of patients
in ongoing clinical investigations;
6) for serious diseases there is sufficient evidence of safety and effectiveness
to support treatment use; and
7) for immediately life-threatening diseases the available scientific
evidence, taken as a whole, provides a reasonable basis to conclude that
the device may be effective in treatment use and would not put patients
at an unreasonable risk.
The FDA may inform national, state and local medical associations and other
appropriate persons of the availability of the investigational device for
treatment use.
The FDA may terminate expanded access under this section if the conditions
under this section are no longer being met.
Effective: February 19, 1998
Section 214 - Practice of Medicine
Nothing in this Act limits or interferes with the authority of a physician to prescribe
or administer any legally marketed device to treat any disease or condition if done within
a legitimate health care practitioner-patient relationship. However, FDA retains its
current authority to restrict the sale, distribution, or labeling of devices and to
prohibit the promotion of unapproved uses.
Effective: February 19, 1998
Sections Related to Premarket Approval
Section 201 - Data from Previous Investigations
Allows for the submission of data from investigations of earlier versions of a device
in support of safety and effectiveness. Such data is only valid if modifications to
earlier versions of the investigational device, whether made during or after the
investigation, do not constitute a significant change that would invalidate the relevance
of the data. In addition, this section allows for the submission of data or information
relating to an approved device that are relevant to the design and intended use of a
device for which an application is pending, provided the data are available for use under
the FFD&C Act. (i.e. available by right of reference or in the public domain)
Effective: February 19, 1998
Section 202 - Special Review for Certain Devices
The FDA will provide special review, which can include expedited processing of a
Premarket Approval (PMA) application, for certain devices intended to treat or diagnose
life threatening or irreversibly debilitating diseases or conditions. To receive special
review, the devices must meet one of the following criteria:
1) the device represents a breakthrough technology;
2) there are no approved alternatives;
3) the use of the device offers significant advantages over existing approved
alternatives; or
4) availability is in the best interest of the patients.
Effective: February 19, 1998
Section 205 - Scope of Review/Collaborative Determinations of Device Data Requirements |
1) non-clinical data that demonstrate the change creates the intended additional
capacity, function, or performance of the device; and
2) clinical data included in the original PMA application or any supplement to that
application that provides reasonable assurance of safety and effectiveness.
However, if needed, FDA may require a sponsor to submit new clinical data to demonstrate
safety and effectiveness.
Effective: February 19, 1998
Section 207 - Risk Based Classification of Postamendment Class III Devices |
An applicant who submits a Premarket Notification Submission [510(k)] and receives a
Not Substantially Equivalent (NSE) determination, placing the device into a Class III
category, can request FDA to classify the product into Class I or II.
The request must be in writing and sent within 30 days from the receipt of the NSE
determination. In addition, the request must include a description of the device, reasons
for the recommended classification (into Class I or II), and information to support the
recommendation. Within 60 days from the date the written request is submitted to FDA, the
Agency must classify the device by written order.
If FDA classifies the device into Class I or II, this device can be used as a predicate
device for other 510(k)s.
However, if FDA determines that the device will remain in Class III, the device cannot be
distributed until the applicant has obtained an approved Premarket Approval (PMA)
application or an approved Investigational Device Exemption (IDE).
Within 30 days of notifying the applicant of the determination that the device has been
classified into Class I or Class II, FDA will announce the final classification in the
Federal Register.
Effective: February 19, 1998
Section 208 - Classification Panels |
1) the same access as FDA to data and information submitted by FDA to a classification
panel, except data not available for public disclosure;
2) the opportunity to submit information based on the PMA, through FDA, to the panel; and
3) the same opportunity as FDA to participate in panel meetings.
Section 209 - For PMA Collaborative Review Process |
The FDA must, upon the written request of the applicant, meet with that party within
100 days of receipt of the filed PMA application to discuss the review status of the
application. With the concurrence of the applicant, a different schedule may be
established.
Prior to this meeting, FDA must inform the applicant in writing of any identified
deficiencies and what information is required to correct those deficiencies. The FDA must
also promptly notify the applicant if FDA identifies additional deficiencies or of any
additional information required to complete Agency review.
Effective: February 19, 1998
Section 216 - Use of Data |
The FDA can now use certain information, contained in approved PMA applications, six
years after the application has been approved to:
1) approve another PMA application;
2) determine whether a Product Development Protocol (PDP) has been completed;
3) establish a performance standard or a special control; or
4) classify or reclassify another device.
Section 216 - Product Development Protocol (PDP) |
The FDA is no longer required to refer all PDPs to panel. The Agency now has
discretion to refer a proposed protocol to an advisory panel for recommendation regarding
approval before making a determination. However, FDA is required to refer the proposed
protocol to the panel if requested by the submitter, unless the protocol and accompanying
data substantially duplicate information that has been reviewed by the panel previously.
Effective: February 19, 1998
Section 217 - Clarification of the Number of Required Clinical Investigations for Approval |
The FDA can rely on one or more clinical investigations to conclude that a device that
is the subject of a PMA application is effective or to establish a device performance
standard.
Effective: February 19, 1998
Section 403 - Approval of Supplemental Applications |
1) clarify when published information can be used as the basis of approval;
2) specify data requirements that will avoid duplication of previously submitted data used
to support the original PMA application; and
3) identify types of supplements that are eligible for priority review.
Effective: Guidance due by May 20, 1998
Sections Related to Premarket Notification [510(k)] |
Section 205 - Collaborative Determinations of Device Data Requirements |
Section 206 - Premarket Notification |
1) is intended for a use which is of substantial importance in preventing impairment of
human health; or
2) presents a potential unreasonable risk of illness or injury.
A 510(k) submission will not be required for specified Class II devices. The FDA plans to
publish in the Federal Register, within 60 days of enactment of the Modernization Act, a
list of Class II devices that are exempt from 510(k).
After the list of Class II exempt devices has been published, additional Class II devices
may be exempted on FDAs own initiative or by petition of an interested person. The
FDA will publish in the Federal Register a notice of intent to exempt these device types
and provide a 30 day period for comment. Within 120 days after the issuance of the notice,
FDA will publish a final order regarding the exemption of the subject devices. If FDA
fails to respond to a petition within 180 days, it will be deemed granted.
Effective: January 20, 1998 upon publication of 510(k) exempt Class II devices.
Section 209 - Certainty of Review Timeframes |
The law directs FDA to review premarket notifications and make a determination not
later than 90 days after receiving the report.
Effective: February 19, 1998
Section 210 - Accreditation of Persons for Review of Premarket Notification Reports |
Background
The FDA is authorized to expand the scope of the existing Third Party 510(k) review
program. The FDA must accredit persons to conduct initial 510(k) reviews no later than one
year after enactment. Accredited persons may not review:
1) Class III devices;
2) Class II devices that are permanent implants or life sustaining or life supporting; or
3) Class II devices which require clinical data, except the number in this group must not
be more than 6% of total submissions (as defined by statute).
1) is substantially not in compliance with this section;
2) poses a threat to public health; or
3) fails to act in a manner consistent with the purposes of this section.
The FDA must make periodic onsite visits to accredited persons to audit performance and
has access to and authority to copy and verify records. Minimum qualifications of
accredited persons include:
1) shall not be a Federal Government employee;
2) must be an independent organization not owned or controlled by a manufacturer, supplier
or vendor of devices and have no organizational, material, or financial affiliation with
such a manufacturer, supplier or vendor;
3) must be a legally constituted entity permitted to act as a third party;
4) shall not engage in design, manufacture, promotion or sale of devices;
5) operate in accordance with generally accepted professional and ethical business
practices and agree in writing that at a minimum it will:
(i) certify that reported information accurately reflects data reviewed;
(ii) limit work to that for which competence and capacity are available;
(iii) treat information received, records, reports, and recommendations as proprietary
information;
(iv) promptly respond and attempt to resolve complaints regarding its activities for which
it is accredited; and
(v) protect against the use of officers or employees to conduct reviews when that person
has a financial conflict of interest regarding the device, and annually disclose in a
public report the extent to which officers and employees have maintained compliance with
requirements relating to financial conflicts of interest.
Effective: May 20, 1998 (publish criteria to accredit persons)
Records Required of Third Parties
Accredited parties must maintain records:
1) documenting the training qualifications of all employees associated with conducting
reviews;
2) documenting the procedures used by the employees for handling confidential information;
and
3) documenting the compensation arrangements and procedures used to identify and avoid
conflicts of interest.
These records are available upon request to FDA at all reasonable times and may be viewed,
copied, or verified. Within 15 days of receipt of a written request from FDA, the
accredited party shall make available copies of the requested records at the place
designated by FDA.
It is a prohibited act for an accredited party to:
1) submit a report that is false or misleading;
2) disclose confidential information or trade secrets without the submitters
consent; and
3) receive bribes or perform a corrupt act.
Access to Accredited Persons
The FDA must provide each person who wishes to use an accredited person a panel of at
least two accredited bodies from which to choose. Compensation for the review will be
based on agreement between the parties.
Progress Reports to Congress
Required reports include:
1) an annual FDA report to Congress that includes the names of all accredited persons,
the activities they are accredited to perform, and the name of each body whose
accreditation has been withdrawn.
2) an FDA report to Congress, to be published in the Federal Register no later than
November 21, 2000, addressing whether the limitation on accredited body review of Class II
devices requiring clinical data should be removed.
3) a Comptroller General report to Congress describing the extent to which the
accreditation program has been implemented, not later than November 21, 2002.
4) a Comptroller General evaluation report to Congress describing the extent to which use
of accredited bodies assisted the Agency in reviewing 510(k)s and the extent to
which such use was contrary to the purposes of the Act, not later than 6 months before the
program terminates.
Authority for the program terminates:
1) 5 years after at least 2 accredited parties are available to do 60% of the 510(k)
reviews; or
2) 4 years after accredited bodies have reviewed 35% of eligible 510(k)s,
whichever occurs first.
Effective: November 21, 1998 (accredit persons to review 510(k) reports)
Sections Related to Device Classification |
Note: Sections 206 and 207 include provisions for the classification
of Class II and Class III devices. Section 206 contains requirements that exempt
certain Class I and II devices from Premarket Notification. Section 207 contains
a requirement that allows for classification of new, low risk Class III devices.
These provisions are addressed in the Premarket Notification (Section
206) and Premarket Approval (Section 207)
portions of this document.
Section 416 - Product Classification (Combination Products)
Any person who submits an application or submission for a product may recommend
to FDA a classification for the product or the component of FDA the applicant
believes to be most appropriate to regulate the product. The request can recommend
classifying the product as a drug, biological product, device, or a combination
product under Section 503(g) of the FFD&C Act.
Not later than 60 days after receipt of the request, FDA must determine the
classification or the component that will regulate the product, and must provide
a written statement to the requester that identifies the classification or component
and the reasons for the determination. The written statement cannot be changed
without consent of the requester or for public health reasons based on scientific
evidence. If FDA does not respond within 60 days, the requesters recommendation
becomes the final FDA determination and cannot be changed without the written
consent of the requester or for public health reasons based on scientific evidence.
Effective: February 19, 1998
Sections Related to Device Labeling |
Section 401 - Dissemination of Information on New Uses |
Manufacturers may disseminate written information concerning the safety, effectiveness,
or benefit of a use not described in a devices approved labeling to health care
practitioners, pharmacy benefit managers, health insurance issues, group health plans, or
Federal or State agencies provided the following requirements are satisfied:
1) unabridged reprints or copies of peer-reviewed, scientifically sound articles
published in scientific or medical journals about clinical investigations involving the
device; or
2) reference publications that include information about clinical investigations.
1) that the use is not approved or cleared by FDA;
2) if applicable, that the information is being disseminated at the expense of the
manufacturer;
3) if applicable, the names of any authors of the information who are employees or
consultants to the manufacturer or have received compensation or have a financial interest
in the manufacturer;
4) the official labeling and all updates;
5) if applicable, a statement that there are products or treatments that have been
approved or cleared for the use that is the subject of the information; and
6) the identification of any person that has provided funding for the study related to the
new use.
the manufacturer includes a bibliography of other articles from
scientific reference publications or journals relating to the use that is the subject of
the information.
if FDA determines that the manufacturer fails to provide data, analyses
or other written matter that is objective and balanced, FDA may require the manufacturer
to disseminate additional objective and scientifically sound information that pertains to
the safety and effectiveness of the use that is the subject of the information and an
objective statement of FDA that bears on the safety or effectiveness of the new use.
And:
the manufacturer has submitted a supplemental application for such use;
Or:
in the case of a completed study, the manufacturer submits to FDA an
application containing a certification that the studies needed for a supplemental
application for the new use are completed and the supplemental application will be
submitted within 6 months after the initial dissemination of information on the new use;
Or:
in the case of a planned study, the manufacturer submits an application
to FDA containing a proposed protocol and schedule for conducting the studies needed for
the supplemental application for the new use and a certification that the supplemental
application will be submitted not later than 36 months after the initial dissemination of
information on the new use;
Or:
Section 421 - Labeling and Advertising Regarding Compliance with Statutory Requirements |
Repeals the restriction in Section 301(l) of the Federal Food, Drug and Cosmetic
(FFD&C) Act, which prohibits reference to FDA approval in the labeling or advertising
of medical devices that have an approved PMA or IDE.
Effective: February 19, 1998
Section Related to Device Tracking |
Section 211 - Device Tracking
The tracking requirement has been changed to eliminate automatic mandatory tracking for
certain devices. The new law gives FDA discretion to order manufacturers of certain types
of Class II or Class III devices to initiate a program to track their medical devices down
to the patient level. The illustrative list that has been published in 21 CFR 821 will be
replaced with a list of products that FDA has ordered to be tracked.
The types of devices subject to a tracking order may include any Class II or Class III
device:
Section Related to Postmarket Surveillance |
Section 212 - Postmarket Surveillance
Manufacturers will no longer be automatically required to conduct postmarket surveillance
studies for particular devices. Rather, FDA may order such studies to be conducted for
certain Class II and Class III devices. The FDA can now order postmarket surveillance for
any Class II and Class III device:
Section Related to Global Harmonization |
Section 410 - Mutual Recognition Agreements and Global Harmonization
Sections Related to Medical Device Reporting and Recall Reports |
Section 213 - Medical Device Reporting |
1) certain actions brought to enforce device requirements under the FFD&C Act; or
2) a communication to a manufacturer of a device that is the subject of a report to FDA of
death, serious illness or injury, or other significant adverse experience.
Effective: February 19, 1998
Section 420 - Safety Report Disclaimers |
The submission of a safety report on a medical device shall not be interpreted as a
conclusion by the person making the submission or by the FDA that the report constitutes
an admission that the product malfunctioned, caused or contributed to an adverse
experience, or otherwise caused or contributed to a death, serious injury, or serious
illness.
Effective: February 19, 1998
Sections Related to Establishment Registration |
Section 213 - Exemption of Wholesale Distributors from Establishment Registration |
Wholesale distributors of devices, who do not manufacture, repackage, process, or
relabel a device, are no longer required to register their establishment with the FDA.
A "wholesale distributor" is defined as any person (other than the manufacturer
or the initial importer) who distributes a device from the original place of manufacture
to the person who makes the final delivery or sale of the device to the ultimate consumer
or user.
Effective: February 19, 1998
Section 417 - Registration of Foreign Establishments |
Section Related to Device Standards |
Section 204 - Device Standards
This section adds a system for recognizing national and international standards in product
reviews. The FDA may, through publication in the Federal Register, recognize all or part
of an appropriate standard established by a nationally or internationally recognized
standards development organization.
A person may reference the recognized standard in a Declaration of Conformity, which can
be used to satisfy a premarket submission requirement [PMA or 510(k)] or other requirement
under the FFD&C Act to which such a standard applies. The FDA can request supportive
data. The FDA may reject the declaration if information supplied does not demonstrate that
the device conforms to the standard, or if the standard is inapplicable.
The FDA may withdraw such recognition of a standard, through publication of a notice in
the Federal Register, if the Agency determines that the standard is no longer appropriate
for meeting a requirement.
The FDA may take action against a firm if information in the Declaration of Conformity is
falsified, or for failure or refusal to provide data or information requested by FDA.
Effective: February 19, 1998
Other Sections Related to Medical Devices |
Section 404 - Dispute Resolution |
This requires the FDA to establish, by regulation, a process under which a sponsor,
applicant, or manufacturer may request a review of a significant scientific controversy,
including a review by an appropriate scientific panel or advisory committee, when no other
provision of the FFD&C Act or regulation provides for such a review.
The Center plans to distribute a guidance for assisting the industry in identifying the
most appropriate course of action for resolving various types of complaints.
Effective: November 21, 1998
Section 405 - Informal Agency Statements |
The FDA shall develop guidance documents with public participation and make these
documents publicly available both in written form and, as feasible, through electronic
means.
The FDA will train employees in how to develop and use guidance documents and will monitor
the development and issuance of such documents.
In developing guidance documents, FDA will ensure uniform nomenclature and internal review
procedures and update and publish a list of these documents in the Federal Register.
Neither FDA nor the public will be bound by the guidance documents; however, FDA will
ensure that its employees do not deviate from such guidance without appropriate
justification and supervisory concurrence.
FDA will obtain public participation prior to implementation of guidance documents that
set forth initial interpretations of a statute or regulation, changes in interpretation or
policy that are of more than a minor nature, complex scientific issues, or highly
controversial issues unless FDA determines that prior public participation is not feasible
or appropriate. In such cases where prior public participation is not feasible or
appropriate, or in instances where the guidance document sets forth existing policy or
minor changes, FDA will solicit public comment upon implementation.
The FDA will develop an appeals mechanism to deal with complaints regarding development
and use of guidance documents.
Effective: February 19, 1998
Effective: July 1, 2000 (issue regulation on policy/procedures for development, issuance
and use of guidance documents)
Section 418 - Clarification of Seizure Authority |
Updated 6/5/1998
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