59250 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

TABLE 2.—Continued

Item No. Title of Standard Reference No. and Date 

K. Tissue Engineering

5 Standard Guide for Characterization and Testing of Hyaluronan as Starting Material Intended for 

Use in Biomedical and Tissue Engineered Medical Product Applications

ASTM F2347–2003

IV. List of Recognized Standards

FDA maintains the agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http://

www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfStandards/search.cfm.

FDA will incorporate the 

modifications and minor revisions 

described in this document into the 

database and, upon publication in the 

Federal Register, this recognition of 

consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary.

V. Recommendation of Standards for 

Recognition by FDA

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the act by submitting 

such recommendations, with reasons for 

the recommendation, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). To be properly considered, 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity.

VI. Electronic Access

In order to receive ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards’’ via your fax machine, call 

the Center for Devices and Radiological 

Health (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 

321 followed by the pound sign. Follow 

the remaining voice prompts to 

complete your request.

You may also obtain a copy of 

‘‘Guidance on the Recognition and Use 

of Consensus Standards’’ by using the 

Internet. CDRH maintains a site on the 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this document 

announcing ‘‘Modifications to the List 

of Recognized Standards, Recognition 

List Number: 011,’’ will be available on 

the CDRH home page. You may access 

the CDRH home page at http://

www.fda.gov/cdrh.

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for FDA recognized consensus 

standards, through the hyperlink at 

http://www.fda.gov/cdrh/stdsprog.html.

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html.

VII. Submission of Comments and 

Effective Date

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Two copies of any mailed 

comments are to be submitted, 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. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

011. These modifications to the list or 

recognized standards are effective upon 

publication of this document in the 

Federal Register.

Dated: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22183 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

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 

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 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;

59252 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

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://

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59253

1FDA 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.

www.aami.org/meetings/courses/

gmp.html1 for specific dates and 

locations.) Please note that you must 

register separately for the training 

session and the examination.

• 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 

59254 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

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 §§ 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:

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 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]

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