[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59250-59255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0117]


Guidance for Industry, Food and Drug Administration Staff, and 
Third Parties; Implementation of the Inspection by Accredited Persons 
Program Under the Medical Device User Fee and Modernization Act of 
2002; Accreditation Criteria; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revising the 
criteria the agency will use to accredit persons for the purpose of 
conducting inspections of eligible device manufacturers under the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which 
established an ``inspection by accredited persons'' program. FDA is 
also announcing the availability of a revised guidance document that 
will provide information for those interested in participating in this 
program. The guidance is entitled ``Implementation of the Inspection by 
Accredited Persons Program Under the Medical Device User Fee and 
Modernization Act of 2002; Accreditation Criteria.'' This revised 
guidance document is immediately in effect, but it remains subject to 
comment in accordance with the agency's good guidance practices. FDA is 
taking these actions to implement recent technical amendments to 
MDUFMA.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Implementation of the 
Inspection by

[[Page 59251]]

Accredited Persons Program Under the Medical Device User Fee and 
Modernization Act of 2002; Accreditation Criteria'' to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John F. Stigi, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 124.

SUPPLEMENTARY INFORMATION:

I. Background

    MDUFMA (Public Law 107-250) was signed into law on October 26, 
2002. Section 201 of MDUFMA adds a new paragraph ``g'' to section 704 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), 
directing FDA to accredit third parties (accredited persons or APs) to 
perform inspections of eligible manufacturers of class II or class III 
devices. This is a voluntary program; eligible manufacturers have the 
option of being inspected by an AP or by FDA. In the Federal Register 
of April 28, 2003 (68 FR 22400), in accordance with section 704(g)(2) 
of the act, FDA published the criteria that it would apply to accredit 
or deny accreditation to persons who request to perform these 
inspections. Under section 704(g)(2) of the act, through publication of 
this Federal Register document, the criteria set out in section II of 
this document are binding on those persons who apply to become APs 
under this program.
    On April 1, 2004, the Medical Devices Technical Corrections Act 
(Public Law 108-214) was signed into law by the President. This law 
made changes to several sections of the act, including section 704(g). 
Most significantly, section 704(g) of the act as amended permits an 
establishment that markets at least one class II or III device in the 
United States and markets or intends to market at least one such device 
in one or more foreign countries to use an accredited third party if 
one or both of the following conditions are met: (1) One of the foreign 
countries certifies, accredits, or recognizes the AP as a person 
authorized to conduct inspections of device establishments or (2) the 
establishment submits a statement that the law of a country where the 
device is marketed or intended to be marketed recognizes an inspection 
by FDA or an AP. Before the technical correction, it was necessary that 
both of these conditions be met before an establishment would be 
eligible to use an AP under this program. FDA is now issuing revised 
criteria as set out in section II of this document and a revised 
guidance document that incorporates the changes made by the Medical 
Device Technical Corrections Act.
    This guidance document supersedes the guidance document that FDA 
issued on April 28, 2003. FDA received three comments on the April 28, 
2003, guidance. FDA reviewed those comments and has addressed them as 
appropriate in this revised guidance.
    FDA is making this guidance document immediately available because 
prior public participation is not feasible. MDUFMA requires that FDA 
implement this program immediately and this guidance is needed to help 
effect such implementation.

II. Accreditation Criteria

    This section describes the criteria FDA will apply when making 
decisions about whether to accredit persons who request to conduct 
inspections of eligible class II and class III device manufacturers in 
lieu of an FDA inspection. The guidance document entitled 
``Implementation of the Inspection by Accredited Persons Program Under 
the Medical Device User Fee and Modernization Act of 2002; 
Accreditation Criteria'' repeats these criteria and provides 
suggestions on how applicants may address them in their application.

A. Minimum Requirements

    Section 704(g)(3) of the act describes the minimum requirements 
that an AP must meet in order to be accredited by FDA. These 
requirements are that an AP:
     May not be a Federal Government employee;
     Shall be an independent organization not owned or 
controlled by a manufacturer, supplier, or vendor of articles regulated 
under the act and have no organizational, material, or financial 
affiliation (including a consultative affiliation) with such a 
manufacturer, supplier, or vendor;
     Shall be a legally constituted entity permitted to conduct 
the activities for which it seeks accreditation;
     Shall not engage in the design, manufacture, promotion, or 
sale of articles regulated under the act;
     Shall operate in accordance with generally accepted 
professional and ethical business practices and agree in writing that, 
at a minimum, it will:
    Certify that the reported information accurately reflects data 
reviewed, inspection observations made, other matters that relate to or 
may influence compliance with the act, and recommendations made during 
an inspection or at an inspection's closing meeting;
    Limit work to that for which competence and capacity are available;
    Treat information received, records, reports, and recommendations 
as confidential commercial or financial information or trade secret 
information, except such information may be made available to FDA;
    Respond promptly and attempt to resolve complaints regarding its 
activities for which it is accredited;
    Protect against the use of any officer or employee of the AP to 
conduct inspections who has a financial conflict of interest regarding 
any product regulated under the act, and annually make available to the 
public disclosures of the extent to which the AP, and the officers and 
employees of the person, have maintained compliance with requirements 
relating to financial conflicts of interest.

B. Additional Criteria

    In addition to the minimum requirements specified in section 
704(g)(3) of the act for becoming an AP, this document also establishes 
the following additional criteria:
1. Personnel Qualifications
    FDA expects APs to have sufficient personnel, with the necessary 
education, training, skills, and experience to review records and 
perform inspections. FDA will consider several factors when accrediting 
applicants. These factors include:
     Whether personnel have knowledge of the following:
    The act (21 U.S.C. 321 et seq.);
    The Public Health Service Act (42 U.S.C. 201 et seq.);
    Regulations implementing these statutes, particularly parts 11 and 
800-1271 (21 CFR parts 11 and 800-1271), with special emphasis on parts 
11, 801, 803, 806, 807, 809, 814, 820, and 821;

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    FDA Compliance Program 7382.845, Inspection of Medical Device 
Manufacturers;
    Guide to Inspection of Quality Systems (QS): Quality System 
Inspection Technique (QSIT); and
    FDA Investigations Operations Manual, Chapter 5 ``Establishment 
Inspection.''
    Whether the applicant:
    Has established, documented, and executed policies and procedures 
to ensure that inspections are performed by qualified personnel, and 
will maintain records on the relevant education, training, skills, and 
experience of all personnel who contribute to the performance of 
inspections;
    Has available to its personnel clear, written instructions for 
duties and responsibilities with respect to inspections;
    Has identified personnel who, as a whole, are qualified in all of 
the quality system disciplines for the inspections under the AP scope 
of work; and
    Has identified at least one individual who is responsible for 
providing supervision over inspections and who has sufficient authority 
and competence to assess the quality and acceptability of inspection 
reports.
2. Infrastructure
    APs need the capability to interface with FDA's electronic data 
systems, including FDA's Internet Web sites and the Center for Devices 
and Radiological Health (CDRH) Facts-On-Demand system. At a minimum, 
this would entail a computer system with a modem and an independent fax 
machine. FDA will rely extensively on the use of our electronic systems 
for timely dissemination of guidance documents to APs and other 
interested parties. APs must also have physical security and safeguards 
to protect trade secret and confidential commercial or financial 
information, as well as personal identifier information in medical 
records, such as adverse event reports, that would reveal the identity 
of individuals if disclosed.
3. Prevention of Conflicts of Interest (COI)
    An AP must be impartial and free from any commercial, financial, 
and other pressures that might present a COI or an appearance of a COI. 
To that end, when deciding whether to accredit a person, we will 
consider whether they have established, documented, and executed 
policies and procedures to prevent any individual or organizational 
COI, including conflicts that their contractors or individual contract 
employees may have.
    Although it is not feasible to identify all of the circumstances 
that would raise concerns about COI in this document, the most common 
conditions that indicate an actual or a potential COI are as follows:
     The AP is owned, operated, or controlled by a 
manufacturer, supplier, or vendor of any article regulated under the 
act. Please see http://www.fda.gov/ohrms/dockets/yellow/yellotoc.htm 
for examples of firms that are regulated by FDA and, therefore, would 
create a conflict. This includes manufacturers of radiation-emitting 
electronic products such as televisions, microwave ovens, compact disk 
players, laser printers, industrial lasers, as well as foods, drugs, 
biologics, cosmetics, veterinary products, and medical devices;
     The AP has any ownership or financial interest in any 
product, manufacturer, supplier or vendor regulated under the act (see 
section II.B.3 of this document);
     Any personnel of the AP involved in inspections or their 
spouse or minor children have an ownership or other financial interest 
regarding any product regulated under the act (see link at section 
II.B.3 of this document);
     The AP or any of its personnel involved in inspections 
participates in the design, manufacture, promotion or sale of any 
product regulated under the act;
     The AP or any of its personnel involved in inspections 
provides consultative services to any manufacturer, supplier or vendor 
of products regulated under the act (see link at section II.B.3 of this 
document);
     Any personnel of the AP involved in the inspection process 
participate in an inspection of a firm they were employed by within the 
last 12 months; and
     The fees charged or accepted are contingent or based upon 
the report made by the AP.
    When the AP uses the services of a contractor in connection with an 
inspection, it is responsible for the work of the contractor and its 
personnel. It will be the AP's responsibility to assure that the 
contractor meets the same criteria for freedom from COI as the AP and 
its personnel.
    In addition to conducting inspections as an AP, an AP may also 
conduct other activities, such as objective laboratory testing of 
products regulated under the act or assessment of conformance to 
standards, if those other activities do not affect the impartiality of 
inspections. Examples of conflicted laboratory testing, i.e., 
activities an AP may not perform, are those tests linked to the 
manufacturing process that are usually performed by manufacturers, such 
as routine quality production tests, validation/verification studies, 
and quality assurance related testing.
    Information on the COI standards FDA applies to its own personnel 
is included in appendix 1 of the guidance entitled ``Standards for 
Ethical Conduct for Employees of the Executive Branch.'' An AP may 
adopt these standards, utilize the model COI policy FDA has provided as 
another appendix to the guidance, or demonstrate how alternative 
equivalent procedures will safeguard against COI.
4. Training
    An AP will not be eligible to conduct independent inspections until 
they have successfully completed the classroom training required by FDA 
and conducted a satisfactory performance inspection under FDA 
observation. Firms identified on FDA's list of APs to perform 
inspections will designate employees to participate in the classroom 
training and joint qualifying inspections.
    Training for APs will be ``modeled'' after training of European 
Union Conformity Assessment Bodies (EU CABs) under the Mutual 
Recognition Agreement (MRA) Implementation Plan. (See http://www.fda.gov/cdrh/mra/guidance/mraprocedure.html.) EU CABs that have 
been accredited as APs and whose personnel have successfully completed 
the required training and/or joint inspections under the MRA program 
should state this in their application. If confirmed by FDA, the AP 
will not be required to have a representative repeat the classroom 
training or joint qualifying inspections. However, FDA does recommend 
that the AP send a representative to the FDA investigator training 
module as an update. Personnel trained by FDA under the MRA program who 
do not attend the current training will need to review a videotaped FDA 
presentation on evidence development.
    The FDA training will consist of a two-tiered program.
    Tier one will include formal classroom training for AP inspectional 
staffers (trainees). At a minimum, this will include:
     The Association for the Advancement of Medical 
Instrumentation (AAMI) Good Manufacturing Practice (GMP)/Quality 
System: Requirements and Industry Practice (or equivalent). AAMI will 
be conducting this training throughout the United States and in foreign 
countries. (See the AAMI Web site at http://

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www.aami.org/meetings/courses/gmp.html\1\ for specific dates and 
locations.) Please note that you must register separately for the 
training session and the examination.
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    \1\ FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.
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     FDA's QSIT training module.
     FDA investigator training, which will include training on:
    Food and Drug Law,
    Advanced QSIT,
    FDA inspectional procedures,
    FDA policies and device regulations, and
    Evidence development.
    FDA will periodically provide either ``face to face'' or electronic 
training for AP inspectors. Each applicant to this program should make 
tentative plans to send appropriate representatives to the FDA 
investigator training. However, only those applicants whose 
applications are approved will be eligible to nominate employees to 
attend the training. Applicants should advise FDA in their AP 
application of the names of the employee(s) who have either 
successfully completed this training or those who will be nominated to 
participate in this training. AP trainees will not qualify to enter the 
second tier unless they successfully pass a test at the end of each 
tier, which is one training session.
    The second tier will involve the completion of three joint 
inspections, during which FDA and the AP will address the relevant 
parts of Compliance Program 7382.845--Inspection of Medical Device 
Manufacturers and the QSIT guidance--Guide to Inspection of Quality 
Systems. The three joint inspections will include:
     Collaborative inspection--The FDA investigator will be the 
lead inspector and the AP trainee will act primarily as an observer. 
The FDA investigator will prepare a list of any nonconformities and an 
inspection report. The trainee will prepare a ``practice'' list of 
nonconformities and an inspection report.
     Modified performance inspection--Using established 
criteria, the FDA investigator will observe and evaluate the trainee 
performance of an inspection and may provide assistance. The trainee 
will prepare a list of any nonconformities to be presented to the 
facility and an inspection report. The FDA investigator will review the 
list of nonconformities and provide feedback before it is presented. In 
addition, the FDA investigator will review the inspection report and, 
if necessary, write an addendum to supplement the inspection report.
     Full performance inspection--The AP trainee will perform 
an independent inspection and will be observed and evaluated by the FDA 
investigator using established criteria. The FDA investigator may not 
provide assistance to the trainee. The trainee will prepare a list of 
any nonconformities to be presented to the facility and an inspection 
report. The FDA investigator will review the list of nonconformities 
and provide feedback before it is presented. In addition, the FDA 
investigator will review the inspection report and, if necessary, write 
an addendum to supplement the inspection report. The FDA investigator's 
evaluation of the trainee and report will be presented to FDA's Office 
of Regulatory Affairs (ORA) certifier in FDA's Division of Human 
Resource Development who will determine if the trainee is qualified to 
perform independent inspections.
    The criteria FDA will use to evaluate the joint inspections will be 
addressed at FDA's training sessions.
5. Evaluation of the AP Application
    After FDA receipt of the AP application:
     The third party recognition board (TPRB) Chairman will e-
mail the applicant's contact person within 24 hours of receipt of the 
AP application, acknowledging receipt.
     Members of the TPRB will perform an initial review to 
determine if the request for accreditation addresses the information 
set forth in section II.B.6 of this document and is adequate for review 
by the full TPRB.
     The TPRB Chairman will advise the contact individual, via 
e-mail, within 60 days after the receipt of such request for 
accreditation, whether the request is adequate for review by the TPRB 
or whether additional information is needed.
     If the application is deficient, FDA will identify its 
shortcomings and advise the applicant to submit additional information 
within the designated time period. FDA may deem the application 
incomplete and deny the request for accreditation if the applicant 
fails to respond to a request for additional information in a timely 
manner. All information submitted to FDA in response to any requests 
for additional information should be received by the date indicated in 
FDA's request. Once such information is received, FDA will file the 
application for full review, rating, and ranking by the TPRB.
    A rating criteria checklist will be used to assess the relevant 
qualifications and competence of persons applying to become APs. The 
agency has assigned a weight (5, 15 or 20) to each of eight elements. 
The eight elements are addressed in section II.B.6 of this document. 
The weight of the element is based on how essential the information is 
in determining if the applicant is suitable to perform QS/GMP 
inspections on behalf of FDA. Each member of the TPRB will assess each 
of the eight elements and will vote a ``quality level'' score from 0 to 
4 (0 = unsatisfactory, 2 = satisfactory, 4 = exceeds) for each element. 
The final quality level score will be determined by a majority vote of 
the TPRB (quality level score x weight = element score). The eight 
element scores will be totaled to yield an ``Application Rating'' 
(maximum rating attainable is 400). Any application with one or more 
elements rated as unsatisfactory will be deemed to have failed to meet 
the criteria established by the AP.
     FDA may deny the request for accreditation if we determine 
that the application does not meet the criteria established for APs.
6. Contents of an AP Application
    Applicants should include the following information:
     Administrative information;
     Application in English;
     Name and address of the organization seeking 
accreditation;
     Telephone number and e-mail address of the contact person. 
The contact person should be the individual to whom questions about the 
content of the application may be addressed and to whom a letter of 
determination and general correspondence will be directed;
     Name and title of the most responsible individual at the 
AP. Foreign applicants may wish to identify an authorized 
representative located within the United States who will serve as the 
AP's contact with FDA;
     Name and title of the most responsible individual at the 
parent organization, if applicable;
     Brief description of the applicant, including: Type of 
organization (e.g., not-for-profit institution, commercial business); 
size of organization (number of employees); organizational charts 
showing the relationship of the organization involved in the AP 
inspection program and its relationship with parent or affiliate 
companies; number of years in operation; nature of work (e.g., 
conformity assessment testing or certification laboratory); and 
sufficient information regarding ownership, operation, and control of 
the

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organization to assess its degree of independence from manufacturers 
and distributors of products regulated under the act. Please include 
your annual report or, if it is available electronically on the 
Internet, please include the appropriate Web site address. If the 
applicant's organization has offices in numerous locations, please be 
specific and name all locations that would participate in the AP 
inspection process for your firm. Applicants may include all locations 
under one application if they will operate under the same processes and 
procedures for AP inspections. Include curriculum vitae (CVs) for all 
supervisory personnel and explain where supervisory oversight will be 
located;
     List of countries that have certified, accredited or 
recognized the applicant for quality system or GMP inspections/auditing 
of medical devices, and the date of such certification, accreditation, 
or recognition;
     Specification of any accreditation for assessment of 
quality systems that you may have, such as accreditation to ISO/IEC 
Guide 62. If you are accredited to standards other then Guide 62, 
please provide copies of the standards in English.
     Activities for which the AP seeks accreditation. This 
includes a list identifying the devices the applicant seeks to inspect. 
Applicants may simply state ``all devices'' or identify the devices 
they wish removed from their scope of work by classification panel or 
by classification name (e.g., all devices except cardiovascular devices 
under part 870 or except Sec. Sec.  870.3620, 870.3630, 870.3640, and 
870.3670).
    Prevention of Conflict of Interest
    The applicant should submit a copy of the written policies, 
procedures, and sample certification/compliance statements established 
to prevent conflicts of interest. MDUFMA requires that the AP and its 
employees (including contract employees) involved in the performance of 
inspections and the preparation and approval of reports be free from 
conflicts of interest and the appearance of conflicts of interest that 
might affect the inspection process. No personnel of an AP involved in 
inspections, nor their spouses or minor children, may have ownership of 
or other financial interest in any product regulated under the act. In 
accordance with section 704(g)(3)(E) of the act, APs will annually make 
available to the public the extent to which the AP complies with 
conflict of interest requirements.
    Technical Competence
    FDA will consider several factors with respect to personnel 
qualifications and the preparedness of the applicant to conduct 
technically competent inspections. The applicant should document these 
factors in its application and include:
     The written policies and procedures established to ensure 
that manufacturers are inspected by qualified personnel;
     The written instructions for the duties and 
responsibilities of personnel, including inspectors, with respect to 
the inspection of device manufacturing facilities;
     The written personnel qualification standards established 
to ensure that inspectors and other designated personnel are qualified 
in all of the regulatory and technical disciplines needed to 
effectively inspect for compliance with FDA's regulatory requirements 
for medical devices;
     The documentation (e.g., CVs) to establish that the 
inspectors and other involved nonsupervisory personnel meet the 
established criteria for qualified personnel. This includes 
documentation of knowledge, education, training, skills, abilities and 
experience, including specialized education and experience needed for 
the inspection of medical device manufacturing facilities;
     The documentation (e.g., CVs) to establish that the 
supervisor(s) of inspectors have sufficient authority and meet the 
established criteria for qualified supervisory personnel. This includes 
documentation of knowledge, education, training, skills, abilities and 
experience, including any specialized education and experience needed 
to supervise the inspection and review records prepared by inspectors;
     A description of the applicant's management structure and 
that of any contractor used for inspection work. The application should 
describe the position of the individual(s) providing supervision within 
the management structure and explain how that structure provides for 
the supervision of the inspectors and other personnel involved in the 
inspection process. (If the applicant plans to utilize contractors, 
please address the additional information described at section II.B.6 
of the document);
     A description of the inspection team. This includes 
documentation for any members of the team who may already have training 
and experience relevant to the assessment of compliance with FDA's 
regulatory requirements for medical devices (e.g., compliance programs, 
the QS regulation, and general auditing principles). The description 
should include documentation of the ability of the team to recognize, 
collect, and identify evidence of noncompliance and adequately 
communicate with the manufacturer regarding the inspection;
     Documentation that personnel involved in inspections have 
basic quality systems knowledge and are qualified in accordance with 
generally accepted quality assurance standards, (e.g., ISO 13485 or 
part 820) and capable of functioning in accordance with the relevant 
parts of these standards;
     Documentation of training plan to assure technical 
competence;
     Documentation of records that demonstrate the appropriate 
experience and training of each inspector.
    Resources
    The applicant should identify what reference materials are 
available to inspectors and other personnel involved in inspections, 
(e.g., the act, regulations, manuals, standards). Also, the application 
should identify equipment and resources available that will enable the 
inspector to perform technical and administrative tasks. At a minimum, 
this should include a computer system with a modem and an independent 
facsimile machine. FDA will rely extensively on the use of our 
electronic systems for timely dissemination of guidance documents to 
APs and other interested parties.
    APs should have physical security and safeguards in place to 
protect trade secret and confidential commercial and financial 
information, as well as personal identifier information in medical 
records, such as adverse event reports, that would reveal the identity 
of individuals if disclosed.
    Confidentiality
    The applicant should include established procedures to ensure 
confidentiality of reports and all information obtained during an 
inspection. These should address aspects of authorized disclosure and 
the procedures by which the applicant maintains confidentiality between 
itself and the manufacturer. In addition, the applicant should describe 
the procedures through which the applicant's personnel and any 
contractors are made aware of confidentiality requirements.
    Contractors
    FDA will consider several factors to determine whether the 
applicant ensures that contractors are properly qualified, utilized, 
and monitored. Special emphasis will be placed on personnel 
qualifications and preparedness to conduct technically competent 
inspections, and on conflict of interest controls. The applicant should 
document these factors in the application and include:

[[Page 59255]]

     The written policies and procedures established to ensure 
that contractors conform to the same requirements (e.g., education, 
training, and experience) that would apply to the applicant if it were 
performing the inspection or aspects of the inspection contracted. 
These policies and procedures should ensure that the contractor 
conducts inspections in accordance with the same procedures under which 
the applicant operates. The applicant should include assurances that it 
will maintain documentary evidence that the contractor has the 
necessary technical competence and resources to carry out contracted 
activities;
     Written policies and procedures documenting that the 
applicant will not contract the overall responsibility for reviewing 
the results of the inspections;
     Documentation of an agreement delineating the duties, 
responsibilities, and accountability of the contractor; and
     The written policies and procedures for establishing a 
register of qualified contractors.
    AP QS
    FDA will consider the following factors to determine whether the 
applicant has established an adequate quality system to ensure 
compliance with FDA policies and procedures relevant to inspections:
     The applicant should establish a documented quality system 
to ensure that there are processes and procedures in place to 
demonstrate compliance with section 704(g) of the act;
     The policies and procedures the applicant follows are 
adequate to maintain control of all quality system documentation and to 
ensure that a current version is available at all locations; and
     The policies and procedures for internal auditing to 
ensure the quality system is implemented effectively and that resources 
are available for conducting such audits.
    Certification Agreement Statement
    The applicant should provide a copy of a documented statement, 
which will be signed by the most responsible individual, certifying 
that:
     The AP has appropriate policies and procedures to meet 
FDA's conflict of interest provisions, has the appropriate staff and 
procedures in place to ensure technical competence for conducting 
inspections under section 704(g) of the act, and has the quality system 
in place to ensure acceptable and consistent inspections;
     Where the AP uses the services of a contractor for QS/GMP 
inspections, the AP should also certify that its contractor(s) meets 
the APs established criteria for freedom from conflicts of interest and 
technical competence;
     The AP consents to FDA inspection and copying of all 
records, correspondence, and other materials relating to any 
inspections conducted by the AP under this program, including records 
on personnel, education, training, skills, and experience and all 
documentation on prevention of conflicts of interest, including 
certification/compliance statements; and
     The AP will protect trade secret and confidential 
commercial or financial information, and will treat as private 
information about specific patient identifiers in records such as 
adverse event reports, except that such information may be made 
available to FDA.

III. The Guidance

    We are issuing a revised guidance entitled ``Implementation of the 
Inspection by Accredited Persons Program Under the Medical Device User 
Fee and Modernization Act of 2002; Accreditation Criteria,'' which 
repeats the AP criteria set out in section II of this document. In 
addition, the guidance provides other useful information such as 
suggestions about the format and content of the accreditation 
applications. The revised guidance reflects changes to the law made by 
the Medical Device Technical Corrections Act.
    The guidance represents the agency's current thinking on the 
``Implementation of the Inspection by Accredited Persons Program under 
the Medical Device User Fee and Modernization Act of 2002; 
Accreditation Criteria.'' The issuance of this guidance is consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

IV. Electronic Access

    To receive ``Implementation of the Inspection by Accredited Persons 
Program Under the Medical Device User Fee and Modernization Act of 
2002; Accreditation Criteria'' by fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system. At the second voice prompt, 
press 1 to order a document. Enter the document number (1200) followed 
by the pound sign (). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

V. Paperwork Reduction Act of 1995

    This document and the guidance entitled ``Implementation of the 
Inspection by Accredited Persons Program Under the Medical Device User 
Fee and Modernization Act of 2002; Accreditation Criteria'' contain a 
proposed collection of information that requires clearance by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information 
addressed in the guidance document have been approved by OMB in 
accordance with the PRA under OMB control number 0910-0510.

VI. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance 
document at any time. Submit two paper copies of any mailed comments, 
except that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Comments received may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22211 Filed 10-1-04; 8:45 am]
BILLING CODE 4160-01-S