[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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;
[[Page 59252]]
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://
[[Page 59253]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 59254]]
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