Office of Health and Industry Programs

Center for Devices and Radiological Health

Food and Drug Administration

Department of Health and Human Services
From the Director

The Office of Health and Industry Programs (OHIP) provides services 

that directly affect the lives of millions of Americans. As one of the 

Offices within the Center for Devices and Radiological Health 

(CDRH), U.S. Food and Drug Administration (FDA), we specialize in 

program-based communication, education, radiological health, 

mammography quality, and reduction of use error.

Outreach and education are in all aspects of OHIP’s work. This is 

evident whether we are producing teleconferences, training CDRH 

staff, working with patients/consumers/health professionals, assuring 

high quality mammography, conducting radiation safety surveys, 

answering device industry questions, or writing regulations. As we 

carry out our programs, we emphasize collaboration both within and 

outside CDRH. Coalition building, public participation, and 

information exchange allow us to obtain input from all relevant and 

concerned sources and to leverage and multiply our resources to 

protect the public health. 

Because of the breadth of our role within CDRH, OHIP serves a wide 

variety of customers, including:

• domestic and foreign manufacturers of medical devices and 

radiation-emitting electronic products;

• domestic and foreign government agencies engaged in 

public health and the regulation of medical devices;

• healthcare professionals and healthcare facilities, as well as 

the organizations that represent them;

• consumers and patients, including all women in the United 

States who receive mammograms; and

• CDRH staff who benefit from training and professional 

development activities.

We think that each of our customers will find programs of interest in 

our FY2001 Annual Report. We think our programs and our 

accomplishments reflect changes and improvements implemented as a 

result of OHIP strategic planning. In 1997, OHIP implemented an 

ambitious five-year strategic plan. 
 

As a first step, we received specific feedback from our customers in 

all of our program areas. While our customers were generally 

satisfied with our services, we received many suggestions and 

comments for changes and improvements. In response to this 

feedback, OHIP developed four specific goals: 

• to use collaboration and cooperation whenever appropriate to 

improve the quality and effectiveness of CDRH programs, to 

enhance the satisfaction of our customers, and to use CDRH 

resources most effectively;

• to consistently produce high quality and timely products and 

services;

• to identify, develop, implement and evaluate innovative and costeffective approaches to accomplish vital new OHIP, CDRH and 

FDA initiatives; and

• to maximize OHIP’s use and development of human and fiscal 

resources.

OHIP is now in the fifth and final year of our strategic planning process. 

As reflected in our Annual Report, OHIP’s four goals are now tightly 

integrated into our programs and daily operations. During the coming 

year, we will continue to update and refine our strategic plan and 

concentrate our efforts on the CDRH strategic plan. As the plan is 

implemented, it will provide broad principles and goals that CDRH will 

commit itself to over the next several years.

Our work is guided by the CDRH mission and 

vision. Mission: to promote and protect the health 

of the public by ensuring the safety and 

effectiveness of medical devices and the safety of 

radiological products. Vision: “Ensuring the 

health of the public throughout the Total Product 

Life Cycle.”
During this past year, OHIP has worked toward the CDRH mission, vision 

and strategic goals. These goals include the following:

• to apply the total product life cycle model across all CDRH 

activities;

• to serve as a magnet for excellence in attracting and retaining a 

diverse workforce who want to help us fulfill our public health 

mission;

• to manage knowledge in support of the total product life cycle 

model; and

• measure and communicate our public health impact.

OHIP continues to work with all of CDRH to implement these strategic 

goals. We co-lead the magnet for excellence goal group and we lead 

outreach efforts inherent in all four goal groups. Together with you, our 

stakeholders, we are preparing a roadmap for the future of OHIP and for 

CDRH. For more detailed information on the CDRH strategic plan, visit the 

CDRH website at http://www.fda.gov/cdrh/ocd/strategic.html.

We welcome your review of OHIP’s FY2001 Annual Report and your 

comments on our programs and future directions.

Sincerely,

Lireka P. Joseph, Dr. P.H.

Director, Office of Health

 and Industry Programs, CDRH
 

TABLE OF CONTENTS

User Education......................................................1

Consumer Webpage................................................................................................. 1

Consumer Inquiries................................................................................................... 2

Breast Implant Information ..................................................................................... 3

Internet Sales.............................................................................................................. 3

New Device Approvals ............................................................................................. 3

Medical Device Recall Webpage..........................................................4

Whole-Body CT Screening Webpage ...................................................4

Reuse............................................................................................................................ 5

Diabetes Webpage ...........................................................................5

Hospital Bed Safety................................................................................................... 6

User Facility Reporting Bulletin............................................................................. 7

Manufacturer Support ...........................................8

Small Business Activities........................................................................................ 9

Assisting Manufacturers .......................................................................................10

Device Advice Webpage......................................................................................12

Workshops/Presentations....................................................................................13

Developing Guidance for Manufacturers...........................................................14

Accredited Persons Program...............................................................................14

International Activities .......................................16

Foreign Manufacturers of Medical Devices......................................................16

Regulatory Training and Assistance..................................................................17

International Conferences....................................................................................17

Global Harmonization.............................................................................................18

U.S./European Mutual Recognition Agreement...............................................19

Radiological Health Programs............................21

Mammography Quality...........................................................................................21

MQSA Webpage...................................................................................................22

Assuring Quality Mammography ........................................................................23

Improving the MQSA Program............................................................................25

MPRIS Web Applications.....................................................................................26

NMQAAC................................................................................................................27
NEXT...........................................................................................................................27

Annual Surveys .....................................................................................................28

NEXT Survey Results...........................................................................................29

TEPRSSC...................................................................................................................31

Federal Facilities Inspections ..............................................................................32

Radiation Safety.......................................................................................................33

Reducing Use Error .............................................34

Human Factors.........................................................................................................35

Labeling......................................................................................................................38

Patient Safety............................................................................................................40

Regulations and Guidance..................................41

Regulations...............................................................................................................41

Good Guidance Practices .....................................................................................42

Plain Language.........................................................................................................43

FDAMA........................................................................................................................45

CDRH Staff College .............................................46

Training Highlights..................................................................................................46

360° Training Program ...........................................................................................48

Electronic Course Evaluations ............................................................................48

CDRH Manager Core Competencies & Learning Pathways.........................50

CDRH Mentoring Program.....................................................................................50

Workplace Assessment.........................................................................................50

Teleconference/Video Production......................50

Appendix................................................................1

Publications and Presentations............................................................................. 1

OHIP Staffing and Organization...........................................................................63

Office of the Director.............................................................................................63

Regulations Staff...................................................................................................63

Staff College ..........................................................................................................63

Division of Communication Media......................................................................64

Division of Mammography Quality and Radiation Programs.........................64

Division of Device User Programs and Systems Analysis .............................65

Division of Small Manufacturers Assistance.....................................................65

OHIP Organization Chart .......................................................................................66
OHIP FY2001 Annual Report, page 1

USER EDUCATION

CDRH regulates medical devices and radiation-emitting electronic 

products that touch upon every phase of our lives. Medical devices are an 

integral part of our healthcare system. Radiation-emitting electronic 

products include cell phones, microwave ovens, television sets, video 

display terminals and many other products that are routinely encountered 

in every day life. 

The users of medical devices and radiation-emitting electronic products 

include patients and consumers, as well as caregivers and healthcare 

professionals. These users all need accurate and up-to-date information. 

Providing this information is an important part of CDRH’s public health 

mission. Within CDRH, OHIP plays a key role in user education. We 

respond to inquiries from individual consumers and patients, and work 

together with other CDRH Offices and outside groups to provide

information on important medical device and healthcare issues. We 

accomplish this through a wide variety of outreach methods including the 

internet, public meetings, and print media.

Consumer Assistance

OHIP is responsible for providing consumers with information needed to 

make informed decisions on the use of medical devices and radiationemitting electronic products. We accomplish this by answering consumer 

inquiries and by developing information that addresses specific, high 

interest issues. For example, in FY 2001 OHIP represented CDRH at a 

Regional Risk Management Pilot Workshop on “Safe Medical 

Treatments-Everyone Has a Role.” This workshop was held in 

conjunction with FDA’s New Jersey District and the Center for Drug 

Evaluation and Research (CDER). It provided a forum for consumers to 

discuss involvement in their own medical care. 

Goals

1. To prepare and disseminate accurate information for consumers, patients and 

others who use medical devices and radiation-emitting electronic products.

2. To respond to consumer and patient inquiries and concerns in a timely and 

caring manner.
OHIP FY2001 Annual Report, page 2

Consumer Webpage

Our “Consumer Page” on the CDRH website is one of our most 

important tools for communicating with consumers and providing 

consumer-related information. 

The CDRH consumer page includes the following:

• information on the products that CDRH regulates; 

• explanation of the process for obtaining FDA clearance to 

market a medical device;

• information on newly approved medical devices;

• other consumer literature as well as links to other health 

related government websites; and

• an easy way to automatically e-mail your questions to OHIP.

Consumer Inquiries

During FY2001, our consumer specialists responded to 

approximately:

• 3,600 telephone inquiries;

• 3,000 e-mails;

• 500 letters and faxes; and

• 4,180 requests for information packages on various medical 

device issues.

P

Click here to 

visit the CDRH 

Consumer 

Information 

Page
OHIP FY2001 Annual Report, page 3

Breast Implant Information 

We collaborated with other CDRH Offices in preparing and 

distributing a brochure entitled, “Breast Implant Risks -

November 2000.” The brochure alerts the prospective breast 

implant recipient of the known consequences of breast implant 

surgery. It describes fifteen known consequences and presents 

pictures of three frequent adverse outcomes. Both the 

brochure on risks as well as the FDA handbook entitled, 

“Breast Implants - An Information Update 2000” can be 

downloaded from the consumer page on the CDRH website. 

Internet Sales

A growing number of medical devices are available for sale on

the Internet. This year, we posted three articles about the sale 

of medical devices on the FDA webpage, “Buying Medicines 

and Medical Products Online.” These articles include a 

general article providing advice for buying medical devices 

on-line and an article devoted to the on-line sale of in-vitro 

diagnostic products. The third article is a Question & Answer

piece about buying contact lenses on the Internet, by phone or 

by mail. The article stresses the importance of having a 

current, correct prescription and receiving regular check-ups.

New Device Approvals

During FY 2001, we collaborated with other CDRH Offices to 

maintain a webpage for New Device Approvals. This page 

includes brief, plain language information on the most recently 

approved medical devices. OHIP provided plain language 

review of 55 one-page summaries for this webpage, which is 

primarily intended for consumers. The page links to other 

sources of consumer information, the Premarket Approval 

(PMA) database, and the patient labeling for these devices.

P

http://

www.fda.gov/

cdrh/mda

P

http://

www.fda.gov/

oc/buyonline

http://www.fda

P

.gov/cdrh/brea

stimplants/ind

exbip.html
OHIP FY2001 Annual Report, page 4

Medical Device Recall Webpage

OHIP and the Office of Compliance prepared a consumer-friendly 

version of medical device recalls for the CDRH website. This page 

provides brief information about CDRH recalls and includes Class I 

medical device recalls (those with the highest level of risk) and some 

Class II and III recalls with general public interest. At present, the 

page contains products recalled during calendar year 2001. As 

CDRH classifies new recalls, OHIP will post them to this webpage 

for public access. 

Whole-Body Computed Tomography (CT) Screening 

Webpage

OHIP led a CDRH working group in developing a webpage on wholebody CT scanning. Some medical imaging facilities are promoting this 

new use of CT. It is marketed to healthy individuals who have no 

symptoms or suspicion of disease as a preventive or proactive healthcare measure. However, the effectiveness of whole-body CT screening 

has not been demonstrated scientifically. This webpage is intended to 

provide information regarding the appropriateness of whole-body CT 

screening to individuals considering such a procedure. Geared toward

consumers and health professionals, it includes:

• information on the use of whole-body CT screening;

• explanation of what CT is and how it works;

• information on radiation risk;

• brief description on radiation quantities used to indicate patient 

dose;

• brief explanation on the regulatory status of CT; and 

• extensive resource list and links to other CT related sites.

 

P

http://

www.fda.gov/c

drh/recalls

http://www.fda

P

.gov/cdrh/ct /
OHIP FY2001 Annual Report, page 5

http://www.fda

P

.gov/diabetes/

Reuse

The reprocessing of single-use devices (SUDs) by hospitals and third 

parties continues to be an important public health issue. During FY2001, 

CDRH conducted an extensive outreach program to educate hospital 

SUD reprocessors about their regulatory responsibilities. The outreach 

program included:

• a brochure summarizing FDA’s regulatory requirements – the 

brochure was sent to 6,000 hospitals in the U.S.;

• a consumer article released through the North American Precis 

Syndicate, Inc. (NAPS) to over 10,000 newspapers;

• four guidance documents (premarket clearance, labeling, medical 

device reporting, and frequently-asked-questions) to further 

clarify the regulatory requirements; 

• featured articles in the User Facility Reporting Bulletin and FDA 

Consumer Magazine; one entire issue of the Bulletin was devoted 

exclusively to SUDs reuse; 

• an extensive reuse website that includes the many important 

polices, letters, and documents about SUDs reuse; 

• a list-serve subscription to alert readers about important issues and 

policies; 

• a reuse speaker's kit distributed to all FDA Field Personnel/Public 

Affairs Specialists to use as a tool in their educational efforts with 

hospitals; and 

• two medical Device Reuse Workshops – Orlando, FL on May 10-

11 and Phoenix, AZ on May 30-31.

Diabetes Webpage

In August 2001, OHIP began leading an agency-wide effort to 

develop a web page on diabetes. This project supports the HHS 

effort to address racial and ethnic disparities in health care, as 

diabetes disproportionately affects many minority populations. 

The Diabetes Webpage is the Center's first disease-specific 

webpage. The page is expected to bring together information 

about all FDA regulated medical products used in the diagnosis 

and treatment of diabetes. The goal of the webpage is to provide 

the unique information the Agency has about the many FDA 

http://www

P

.fda.g

ov/

fdac/features/ 

2000/ 500_reuse.

html
OHIP FY2001 Annual Report, page 6

regulated products used by patients with diabetes and their caregivers. 

We hope the outcome will be healthier lives for the rapidly growing 

number of Americans that are diagnosed with diabetes. We 

collaborated with FDA’s Office of Women’s Health and the American 

Diabetes Association. Links to other government and non-profit 

organizations will be included to augment FDA's information. The 

page will be a working document and we will continue to add 

information targeted to populations which are disproportionately 

affected by diabetes.

Hospital Bed Safety

OHIP led a multidisciplinary group to address the safety issues of 

hospital beds and patients vulnerable to entrapment. The group 

included representatives from the US and Canadian governments,

national health care organizations, manufacturers of hospital beds, 

patient advocate groups and medical researchers. This group is

working to reduce the number of patient deaths and injuries from 

hospital bed entrapments in all care settings, including hospitals, 

nursing homes, and private homes. The CDRH-led Hospital Bed 

Safety Workgroup developed hospital bed guidance that defines the 

recommended limits for gaps or openings in hospital bed rails. The 

guidance also provides procedures for clinicians to assess whether a 

bed meets the recommended limits. In addition, the workgroup has 

developed an assessment tool for facilities to determine if an opening 

falls outside the recommended limits. Other projects nearly 

completed include a Correction Action Guide to assist facilities in 

modifying the beds determined to be at risk for entrapment, and 

Clinical Recommendations for caregivers to use when assessing their 

patients’ need and use of bed rails. As a result of these efforts, CDRH 

developed a website to report the work of the Hospital Bed Safety 

Workgroup, increase awareness of the entrapment issue and educate 

the public on the problems related to this issue.

http://www.fda.

P

gov/cdrh/beds/in

dex.html
OHIP FY2001 Annual Report, page 7

User Facility Reporting Bulletin

In the winter of 2001, we prepared the 37th issue of the User Facility 

Reporting Bulletin. First issued in 1992, the Bulletin is published 

quarterly. The Bulletin provides user facilities with:

• important information on preventing adverse events with 

medical devices;

• directions for reporting adverse events to the FDA; and 

• feedback on reported problems. 

When first published, the Bulletin had a printed circulation of over 

75,000. In order to make more efficient use of resources and 

technology, the Bulletin is now available solely on our website. 

P

http://

www.fda.gov/

cdrh/ 

fusenews.html
OHIP FY2001 Annual Report, page 8

MANUFACTURER SUPPORT

Safe and effective medical devices are crucial to our healthcare 

system. FDA regulated medical devices include over 100,000 

different types of products in more than 1,700 product categories. 

They range from simple everyday articles such as thermometers, 

tongue depressors and heating pads to more complex devices such as 

pacemakers, defibrillators and kidney dialysis machines. Overall, 

medical devices are becoming increasingly complex. Improved, lifesaving devices are using innovations such as microprocessor control, 

artificial intelligence, miniaturization and remote operation.

Members of the medical device industry are just as diverse as the 

products that they manufacture:

• there are approximately 14,000 manufacturers of medical 

devices worldwide;

• more than 70 percent of medical device manufacturers are 

small enterprises with fewer than 50 employees; and,

• more than 40 percent of device firms manufacture abroad.

This complexity and diversity present a challenge to FDA as a 

regulatory and public health agency. They also present a challenge to 

the medical device manufacturers who must comply with FDA 

regulations. Better communication between FDA and manufacturers 

opens the door for improved understanding, provides for a better 

working relationship, and results in quicker access to devices by the 

public.

Goals

1. To provide technical assistance in meeting FDA requirements for medical 

devices and radiation-emitting electronic products.

2. To develop informational materials and to provide accessible, efficient 

channels for distributing information to manufacturers.

3. To respond to manufacturer inquiries in a comprehensive and timely manner.
OHIP FY2001 Annual Report, page 9

Small Business Activities

FDA has instituted a number of activities aimed specifically at 

increasing communication with the small business community. 

In addition to Small Business Assistance Programs that reside in 

each of the five FDA regional offices, each Center in FDA has a 

special small business unit. 

Within CDRH, OHIP serves as a focus for small business 

concerns. We strive to:

• identify ways in which FDA requirements can protect and 

promote the public health without being unfair 

or unduly burdensome to small business;

• encourage greater participation by small firms in 

the regulatory process itself, especially at the 

early stage when comments are sought on 

proposals that impact on the device industry; 

and

• educate CDRH staff on the needs of medical 

device manufacturers and potential problems 

they face in meeting FDA’s regulatory 

requirements.

The specific types of assistance that we provide to small businesses are 

similar to those that we provide to other domestic and foreign manufacturers 

of medical devices. These are discussed in more detail in the following 

pages.

General 

Information 

Package

We provide 2,000 

General Information 

Packages each year to 

new companies entering 

the device industry. To 

obtain a copy of this 

package, fax your request 

to 301-443-8818.

P

http://

www.fda.gov/

ora/fed_state/

small_business/

sb_guide/

intro.html
OHIP FY2001 Annual Report, page 10

P

http://

www.fda.gov/

cdrh/dsma/ 

510_stat.html

Assisting Manufacturers

The most fundamental assistance that OHIP provides to manufacturers 

involves our response to individual inquiries, questions and concerns. 

We do this through several mechanisms, including:

• Automated Call Center: We maintain an automated call 

center to provide superior customer service. The call center 

advises the caller of their place in the queue and the average 

wait time. While in queue the caller hears messages about 

issues of interest to CDRH stakeholders. The caller can stay 

on the line or select another option, such as 

leaving a voice mail or making another 

choice from the main menu. This system is 

available 24 hours per day (see inset) and 

offers manufacturers the opportunity to 

speak directly to a device specialist who can 

answer their questions and direct them to 

the needed information. We typically 

receive and respond to an average of 35,000 

telephone inquiries per year. 

• E-mail: All of our webpages for 

manufacturers, and many other CDRH 

webpages, include access to our e-mail 

account – dsmica@cdrh.fda.gov. We 

respond to over 12,000 e-mail inquiries per year. In 

addition, we receive approximately 2,200 written/fax 

inquiries per year.

• 510(k) Status Program: We assist manufacturers 

in determining the status of their pending premarket 

notification applications (510(k)). Requests for this 

service have decreased dramatically as CDRH 

eliminated the backlog of 510(k) applications. 

However, we still receive approximately 500 

requests each year. The link to the left provides 

instructions on this program.

OHIP/CDRH

Division of Small 

Manufacturers 

Assistance

800-638-2041

301-443-6597

Automated Assistance 

available 24/7

Device Specialists

available M -F

8 a.m. to 5 p.m., EST
OHIP FY2001 Annual Report, page 11

P

http://

www.fda.gov/

cdrh/dsma/ 

dsmamain.html

• Broadcast Fax: OHIP uses an automated fax system to rapidly distribute 

important CDRH information to our industry. We also distribute 

information to stakeholder organizations such as AdvaMed, RAPS, and 

FDLI who then provide a multiplier effect. During FY 2001, we 

distributed information on several topics, including upcoming 

workshops/conferences on Reuse of single use devices, HACCP, and the 

Global Harmonization Study Group 1 “Medical Device Classification” 

document.

• Facts on Demand (FOD): FOD is an automated 

answering system that allows you to access over 

700 CDRH publications through your FAX 

machine. Almost all of the documents available 

by FOD are more easily available from the CDRH 

webpage. However, stakeholders still use FOD to 

obtain publications. In FY 2001, approximately 

8,000 publications were obtained through this 

system. We continue to maintain this system by 

adding new guidance documents as they become 

available and removing the outdated documents. 

• Publication Distribution: OHIP is a warehouse 

to over 1,000 FDA publications. Although 

approximately 80 percent are accessible 

electronically, our stakeholders still request 

hardcopies. In FY 2001, approximately 50,000 publications were 

distributed either by hardcopy or on diskette. 

• Manufacturers Assistance Webpage: Our webpage is a 

comprehensive source of information for manufacturers. It 

provides easy access to the services we offer, issues of interest 

to manufacturers and copies of manuals and guidance 

documents. The site received 54,600 hits in FY 2001. In 

response to the large volume of this type of work performed by 

the division, OHIP officially renamed the Division of Small 

Manufacturers Assistance (DSMA) to the Division of Small 

Manufacturers, International and Consumer Assistance 

(DSMICA) in July 2001 in an effort to more accurately describe the 

services we provide. 

CDRH

Facts on Demand

800-899-0381

301-827-0111

Catalog available on your fax machine 

after dialing the above number and:

ß Press "1" to enter the system and 

obtain documents; or

ß Press "2" to obtain instructions 

for using the system

ß Press "INDX" (4639 on the 

keypad) to request an index for 

all documents. 

The index can also be found at 

http://www.fda.gov/cdrh/dsma/

fod.html. 
OHIP FY2001 Annual Report, page 12

Device Advice Webpage 

Early on, we recognized both the advantages and the 

limitations of providing extensive information for 

manufacturers on our website. Often, just having 

“access” to all of our information doesn’t make it easy 

to find the particular document or information that you 

are seeking. Further, while you might find a particular 

document, you might not be aware of related documents 

or information. To address these concerns, OHIP 

designed and implemented Device Advice. This webpage has been a 

successful source of information and received 59,326 hits in FY 2001. 

With Device Advice, you can determine:

• whether the product you want to market is

ÿ a radiation-emitting electronic product,

ÿ a medical device,

ÿ both a radiation-emitting electronic product and a 

medical device, or,

ÿ neither a radiation-emitting electronic product nor a 

medical device;

• the FDA reporting requirements and standards that may 

apply for a radiation-emitting electronic product;

• the classification of the product, if it is a medical device;

• the process for obtaining appropriate clearance to market the 

medical device; and

• information on any other requirements that might apply to 

your product.

Device Advice is an interactive system that 

will guide you through the process of obtaining 

FDA clearance to market a medical device and 

to meet FDA requirements for radiationemitting electronic products.

P

http://

www.fda.gov/

cdrh/ 

devadvice
OHIP FY2001 Annual Report, page 13

Device Advice can also be used as a resource linking to regulatory manuals, 

precedence correspondence, import/export requirements, CDRH databases 

and a complete index of the Code of Federal Regulations (Title 21 CFR).

OHIP device specialists programmed the first “version” of Device Advice in 

1998. Since then, it has consistently been one of the ten most used CDRH 

webpages. In FY 2001, we modified topics to include the following 

information:

• IDE Supplements

• PMA Supplements and Amendments Section

• Import for Export

• CLIA Section within the 510(k) Section

• CBER 510(k) Reviews

• Corrections and Removals

• Sunglass Guidance

• Quality Systems 

• International Organization for Standardization (ISO)

Workshops/Presentations

During FY 2001, OHIP partnered with other organizations in 

presenting 12 workshops for manufacturers. The workshops 

allow us to meet with manufacturers face to face and to 

exchange information on topics such as regulatory requirements, 

Quality Systems, and import and export requirements. Our 

partners in presenting the workshops included the following 

organizations: 

• Association for the Advancement of Medical Instrumentation 

(AAMI)

• Canon Communications

• Regulatory Affairs Professional Society (RAPS)

• Association of Medical Diagnostic Manufacturers (AMDM)

• AdvaMed

• Medical Alley

• American Society for Quality (ASQ)

P

http://

www.fda.gov/

cdrh/dsma/

workshop.html
OHIP FY2001 Annual Report, page 14

Developing Guidance for Manufacturers 

In addition to facilitating manufacturers’ access to all CDRH guidance 

documents, OHIP staff also prepare guidance documents in their areas 

of expertise. These guidance documents may be prepared entirely 

within OHIP or in collaboration with staff from other CDRH Offices. 

Recent guidance documents include:

• Draft Guidance for Staff, Industry and Third Parties: 

Implementation of Third Party Programs Under the FDA 

Modernization Act of 1997. February 2, 2001.

• Sunglasses, Spectacle Frames, Spectacle Lens and 

Magnifying Spectacles. June 19, 2001.

Accredited Persons Program

OHIP administers the Accredited Persons Program for 

CDRH. This program allows manufacturers to use 

“Third Parties” to conduct initial review of premarket 

notification (510(k)) submissions for low (Class I) to 

moderate (Class II) risk devices. The Accredited 

Persons (AP’s) are individuals or organizations who 

meet qualifications and requirements established by 

FDA and who are then “accredited” to do these 

reviews. This program has the potential to provide 

manufacturers with more rapid clearance decisions for their devices. 

At the same time, FDA would be able to focus its resources on higher 

risk devices.

Both FDA and the medical device industry have been disappointed 

that the Accredited Persons Program has not been used more. 

Therefore, OHIP has worked closely with the Office of Device 

Evaluation to significantly expand the scope of the AP program in 

FY2001. Specifically, the following efforts took place in order to 

address this concern:

• In February 2001, we implemented an expansion pilot that allows 

AP’s to review Class II devices for which there are no device-specific 

guidance documents. Implementation of the pilot expanded the 

number of eligible devices to 674 by adding over 450 Class II devices. 

P

http://

www.fda.gov/

cdrh/ 

thirdparty
OHIP FY2001 Annual Report, page 15

Implementing the expanded pilot program represents more than a 

300% increase in eligible devices. Also, there was an increase in third 

party submissions of 510(k)s by AP’s of almost 130% in FY 2001.

• In February 2001, we issued a final guidance document that includes 

criteria allowing for the review of the Class II pilot devices, entitled 

Guidance for Staff, Industry and Third Parties: Implementation of 

Third Party Programs Under the FDA Modernization Act of 1997.

• In June 2001, we conducted the second training session for third 

parties since the Accredited Persons Program began in 1998.

• In July 2001, we drafted a letter that was issued on September 17, 

2001 from Secretary Thompson to Congresspersons W.J. Tauzin and 

Edward Kennedy advising them that we reached milestones that 

exceed those in the “sunset provision of FDAMA. This provision 

specifies that authorization of the program will end 5 years from the 

date of the letter.
OHIP FY2001 Annual Report, page 16

INTERNATIONAL ACTIVITIES

The concept of a “global marketplace” is especially true in the case of 

medical devices. Forty percent of approved device firms have 

manufacturing facilities abroad. There are approximately 6,000 

foreign establishments that export devices to the United States. 

Device development studies are conducted worldwide. As a result, 

post-marketing vigilance for medical device problems is becoming a

worldwide network. The inspection methods used by national 

regulatory agencies are converging in an effort to assure a consistent 

regulatory process across continental boundaries.

Foreign Manufacturers of Medical Devices

During FY2001, OHIP 

continued to provide 

manufacturer support to 

foreign firms bringing medical 

devices into the United States. 

In addition, there were 

significant developments in 

activities associated with the 

Global Harmonization Task 

Force and the U.S./European Mutual Recognition Agreement. Our 

International Programs webpage was designed to consolidate 

information on CDRH’s international activities in a single location. 

OHIP uses the same mechanisms to support foreign manufacturers as 

those used for domestic manufacturers. During FY2001, our 

assistance to foreign manufacturers included:

• answering more than 1,500 telephone inquiries;

Goals

1. To assure the safety and effectiveness of imported medical devices by 

assisting foreign manufacturers to comply with U.S. medical device 

regulations.

2. To direct U.S. firms to sources of information on foreign requirements for 

medical devices.

3. To support global harmonization activities.

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OHIP FY2001 Annual Report, page 17

• responding to more than 1,500 e-mails and 500 letters and faxes; 

and

• mailing more than 470 information packages on various medical 

device issues.

In addition, the International Programs Webpage received 10,674 hits 

throughout the year.

Regulatory Training and Assistance

OHIP coordinates the education of foreign governments on the U.S. medical 

device regulatory process. This may involve seminars and presentations or 

arrangements for more in-depth learning experiences while at CDRH. OHIP 

and other CDRH offices participate in these activities. During FY2001, they 

included: 

• Russian Ministry of Health – presented medical device overview; 

• Argentina Ministry of Health – presented medical device 

overview;

• Philippines Department of Health – two month training; 

• South Africa Department of Health – one week training;

• Australia Therapeutic Goods Administration – presented medical 

device overview;

• Finland National Technology Agency – presented medical device 

overview; 

• Danish Consulate – presented medical device overview;

• Japan Ministry of Health – presented medical device overview;

• Mexican Government – presented medical device overview; and

• Canada – presented medical device overview.

International Conferences

As with OHIP’s educational efforts for the domestic device industry, we also 

participate in international conferences to promote compliance with U.S. 

medical device regulations. During FY 2001, OHIP participated in 18 

international industry professional conferences. Recent presentations 

include:

• Japan – Overview of the US/EC Mutual Recognition 

Agreement;

• Germany – Overview of Quality Systems;
OHIP FY2001 Annual Report, page 18

• Malaysia – Global Harmonization;

• China – US Regulatory Requirements;

• Singapore – Overview of Quality Systems; and

• Canada – Overview of Medical Device Regulation.

Global Harmonization

The Global Harmonization Task Force (GHTF) is comprised of 

government and industry representatives from the United States, 

Canada, the European Union, Japan, and Australia. Representatives 

from other countries also attend meetings and conferences, and 

participate in discussions of issues. GHTF members are working to 

build an international consensus on medical device regulatory policies 

and practices. The goal is to encourage convergence of medical 

device regulation worldwide to facilitate international trade, promote 

technological innovation, and enhance public health. 

• In October 2000, OHIP participated at a GHTF seminar for 

embassy/consulate representatives sponsored by FDA’s 

Office of International Programs (OIP).

• OHIP participated in CDRH post-staff briefing on GHTF 

study group activities.

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OHIP FY2001 Annual Report, page 19

• OHIP coordinated CDRH participation in a videoteleconference to 

brief Brazilian regulatory officials on the GHTF’s structure, goals, 

and procedures, as well as the study groups, their focus, and 

guidance documents.

• OHIP coordinated plans for CDRH representatives to attend the 

9th Annual Conference of the GHTF in Barcelona, Spain in 

October 2001. However, the conference was cancelled due to the 

events of September 11, 2001.

U.S./European Mutual Recognition Agreement 

The United States and the European Commission (EC) have signed a 

mutual recognition agreement (MRA). The MRA covers a variety of 

“product sectors” that include telecommunication equipment, 

electromagnetic compatibility (EMC), pharmaceutical good 

manufacturing practice (GMP), electrical safety, recreational craft, 

and medical devices. With regards to medical devices, the MRA 

relies on independent third parties from each exporting country to 

audit medical device manufacturers and to conduct product reviews 

according to the importing parties’ requirements. To that end, the 

MRA may enhance FDA’s ability to ensure that the health and safety 

of U.S. consumers are protected.

OHIP leads CDRH’s implementation of the medical device annex of 

the MRA. In FY2001, our accomplishments include:

• Together with the Commission for the European Community

(CEC), we prepared the Second Annual Report on the Medical 

Device Annex to the MRA. The report includes background on the 

MRA and a chronology of accomplishments from December 1, 

1999 through December 1, 2000.

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OHIP FY2001 Annual Report, page 20

• Together with other CDRH offices, we participated in three

stakeholders meetings to provide an update on progress of the 

MRA including confidence building activities and to allow for 

discussions and clarification.

• Published a Federal Register notice announcing the availability of 

Version #7 of the MRA Draft Implementation Plan.

• OHIP sent summaries, checklists and supporting evidence for 8 

U.S. Conformity Assessment Bodies (CABs) to the CEC.

• A representative from OHIP taught a course on FDA’s Quality 

System Regulation sponsored by AAMI in Frankfurt, Germany for 

designated European Union (EU) CAB auditors and EU 

Designating Authorities as part of confidence building.

• Two OHIP representatives participated at U.S. Department of 

Commerce (DOC) sponsored seminars in four U.S. cities to 

promote the MRA.

• Prepared and presented to the EU a proposed expansion of the 

eligible device list for premarket review. Adoption of the new 

tables I and II would increase the number of eligible devices from 

97 to over 500.

• CDRH and ORA, led by OHIP, worked with the CEC to edit 

Version #10 of the MRA Implementation Plan.

• Continued to work to facilitate the Third Party Review Board’s 

review of EU CAB dossiers to verify conformance with FDA 

criteria. Reviews of dossiers from four EU CABs are nearing 

completion. 
OHIP FY2001 Annual Report, page 21

RADIOLOGICAL HEALTH PROGRAMS

Radiological health is an important part of CDRH’s public health 

mission. We assure the safety of consumer and industrial radiationemitting electronic products. We promote the safe use of radiation in 

medicine by reducing unnecessary radiation exposure and by 

improving diagnostic image quality. However, CDRH resources for 

radiological health are at an all-time low. Reallocation to medical 

devices, personnel attrition and changes in product technology are just 

some of the factors involved. Within CDRH, a Radiological Health

Council has been formed to revitalize our radiological health 

programs. The Council continues to pursue a variety of initiatives to 

assure and enhance the cost-effectiveness and public health benefits of 

CDRH radiological health programs.

Within OHIP, nearly one-third of our staff are involved in radiological 

health programs. As described below, we are using third parties, 

cooperative programs with the States, leveraging and other innovative 

approaches to address important public health problems. 

Mammography Quality

OHIP implements the Mammography Quality Standards Act of 1992 

(MQSA). Congress enacted MQSA to ensure that all women have 

access to quality mammography for the detection of breast cancer in 

its earliest, most treatable stages.

Each year, approximately 180,000 

women are diagnosed with breast 

cancer. Approximately one 

woman in nine will develop breast 

cancer in her lifetime. Early 

detection and prompt treatment of 

breast cancer has been 

demonstrated to reduce mortality 

by one-third in women over fifty. 

Mammography (x-ray examination 

of the breast) is the best tool 

available for the early detection of 

breast cancer. It is essential that 

all mammographic examinations 

be of the highest quality.
OHIP FY2001 Annual Report, page 22

Under MQSA, every mammography facility must meet baseline 

national quality standards. Mammography facilities include breast 

clinics, radiology departments in hospitals, mobile vans, private 

radiology practices, and other doctors’ offices. For each facility, an 

FDA-approved accreditation body conducts a thorough review of the 

mammography facility’s equipment, personnel (interpreting 

physicians, radiologic technologists, and medical physicists), and 

practices (including clinical image quality). We issue an MQSA 

certificate to facilities that meet the quality standards. Certification 

can be renewed as long as the facility remains properly accredited and 

demonstrates continued compliance with MQSA quality standards 

through annual inspections performed by FDA-trained Federal or 

State inspectors. Only MQSA certified facilities can lawfully provide 

mammography services.

MQSA Webpage

There are many facets to enforcement of the 

Mammography Quality Standards Act. Detailed 

information on all aspects of the MQSA program can be 

found at the Mammography Program website. This 

includes a list of all certified mammography facilities that 

is searchable by zipcode or State. 

Goals

1. Assure consistent availability of high quality mammographic examinations, 

nationwide.

2. Update regulations and standards to reflect new technology. 

3. Fulfill CDRH’s statutory obligations under the MQSA Final Rule in the most 

cost-effective manner.

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OHIP FY2001 Annual Report, page 23

Examples of documents currently available on the webpage (link on 

previous page) include: 

• FDA’s Mammography Program: An Overview;

• Mammography Quality Standards Act;

• Federal Register Notices;

• Mammography Quality Standards Reauthorization Act of 1998;

• Mammography Matters newsletters;

• policy guidance documents;

• listing of certified mammography facilities;

• Mammography Facility Performance Reports; 

• Speaker’s kit: MQSA Final Regulations;

• MQSA Program Accomplishments; and 

• consumer-specific information. 

Assuring Quality Mammography

Approximately 9,500 certified mammography facilities operate in the 

United States, including federal and military. To be certified to 

conduct mammography, each facility must be accredited by an FDAapproved accreditation body. At the end of FY2001, the five 

accreditation bodies and the number of facilities they accredit were:

• American College of Radiology (8,752) 

• State of Arkansas (75)

• State of California (465)

• State of Iowa (140)

• State of Texas (126)

To assure mammographic quality, mammography facilities undergo 

annual inspections by FDA trained inspectors1. FY2001 was the 

second full year of inspections under the MQSA Final Regulations. 

Nearly 9,300 inspections take place each year. Results from FY 2001 

are shown in Figure 1 on the following page.

 

1

 The MQSA inspection program includes FDA inspections of federal facilities performing mammography. 

MQSA-like inspections are also performed for the Veterans Health Administration (VHA) through an 

Interagency Agreement.
OHIP FY2001 Annual Report, page 24

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Figure 1. Preliminary FY 2001 Inspection Results

Level 2

28.1%

Level 3

10%

No Finding

58.5%

Level 1

3.4%

• Inspectors can issue three 

levels of findings. Level 

1 represents the most 

serious noncompliance 

with MQSA standards. 

Level 2 represents 

moderate noncompliance. 

Level 3 represents minor 

noncompliance.

• Regardless of the level, a 

facility must correct all 

deficiencies found during 

an inspection.

• 58.5% of the mammography facilities

 had no adverse findings;

• about 3.4% of the inspections 

found the most serious type of 

problems (“Level 1 finding”) –

facilities must correct problems or 

lose their certification; and

• Level 1 and Level 2 percentages 

were lower, the Level 3 remained 

constant, and the “no findings” 

percentages were higher than the 

previous year.

Since the beginning of the MQSA program, significant problems at 

eleven facilities led FDA to require that patients and physicians be 

notified of concerns related to the quality of their mammographic 

examinations (see link to Mammography Facility Performance Report 

at right). In each case, the patients and referring physicians served by 

these facilities were notified about the image quality problems at the 

facilities and were advised of the health risk. As a result, the patients 

and referring physicians were able to arrange for appropriate healthcare 

followup. (Note: State actions against mammography facilities are 

reported separately.)

As part of its continued efforts to assist MQSA inspectors to maintain 

consistent and uniform performance, FDA established an Inspector Quality 

Assurance Program. This program requires inspectors to conduct a 

minimum of 12 inspections yearly, obtain 15 continuing education units in 

mammography-related training (MEU’s) over a three-year period, and 

undergo an annual audit by an FDA MQSA-certified auditor. In FY2001, 

FDA completed audits of every certified inspector.
OHIP FY2001 Annual Report, page 25

Improving the MQSA Program

The mammography program strives to provide better value, improved customer 

service, and improved public health. Some of the major innovations during 

FY2001 are listed below.

• Digital Mammography: CDRH’s Office of Device Evaluation 

approved the first Full Field Digital Mammography (FFDM) system, the 

GE Senographe 2000D, for commercial use in January 2000. A second 

FFDM unit, the Fischer SenoScan, was approved in September 2001. 

The new technology promises to enhance mammography by reducing 

the need for some women to have additional exposures, while allowing 

interpreting physicians to quickly and easily manipulate the images. At 

this time digital units are exempt from MQSA accreditation 

requirements. However, the accreditation bodies are developing a 

process for accrediting FFDM units. For an MQSA certified facility to 

lawfully use the FFDM system, it must: 

ÿ maintain its accreditation status for at least one screen-film unit;

ÿ submit an application with required information to FDA; 

ÿ ensure that any interpreting physician, medical physicist, or 

radiologic technologist has eight hours of initial training in the 

new modality before using it clinically;

ÿ provide a satisfactory FFDM equipment evaluation; 

ÿ follow the manufacturer’s guidelines for quality assurance and 

quality control tests; and

ÿ receive approval from FDA.

• States as Certification Agencies (“States as Certifiers”): This 

project successfully transferred certain key MQSA responsibilities to 

the States of Illinois and Iowa. The program authorizes qualified States 

to certify mammography facilities within their jurisdiction, conduct 

inspections, and enforce the MQSA quality standards under FDA 

oversight. The Department of Health and Human Services (DHHS) 

released the final regulations for publication on January 18, 2002. 
OHIP FY2001 Annual Report, page 26

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• Comprehensive electronic guidance: All MQSA 

regulatory guidance materials and documents are now 

compiled into the MQSA Policy Guidance Help System 

(PGHS). Mammography facilities and other interested 

parties now have access to a comprehensive online resource 

accessible through MQSA’s web page. Users of the PGHS 

can search for answers to specific policy questions through 

an indexed list of topics and key words. For example, by 

selecting a particular subject, such as “revocation of 

accreditation” or “accreditation and certification,” the user 

will find the regulatory citation, any relevant guidance 

documents, and any other appropriate information and references.

MPRIS Web Applications

In response to numerous requests from State programs to provide more 

open access to the Mammography Program Reporting Information 

System (MPRIS) database, we developed ‘modified view-only’ versions 

of the two web-based MPRIS applications: (1) the Certification 

Accreditation Support System (CASS); and (2) the Facility 

Noncompliance Tracking and Management System (FaNTMS). 

Using the CASS web application, current facility and unit certification 

and accreditation information and reports are now available to the States 

and the Districts on-line at any time. The State Facility Listing Report 

in CASS, which can be exported, replaced the monthly printed report 

that became rapidly outdated and was expensive for the Division to print 

and mail. The user is also able to print reports for an individual facility.

FaNTMS was also modified especially for view-only use. Using 

FaNTMS, a State inspector or supervisor is able to search for inspections 

in their State using several criteria. They may also view noncompliance 

and general inspection information and print or export a variety of 

reports such as the Inspection Detail and Post-Inspection Reports. 

FaNTMS provides complete descriptions of each report and on-line help 

is also available. In the Spring of 2001, a third version of FaNTMS was 

released designed for use by SAC States. This version has all the 

features of the FDA version, such as entering and editing 

correspondence and closing out noncompliances and inspections, except 

that the view of MPRIS data is limited to the SAC State. 
OHIP FY2001 Annual Report, page 27

NMQAAC

The National Mammography Quality Assurance Advisory Committee 

(NMQAAC) is a committee established by MQSA to advise FDA on the 

implementation of the MQSA program. During FY-2001, NMQAAC 

met to discuss the issuance of guidance on the MQSA final regulations, 

and the appropriateness of current inspection follow up actions. At the 

meetings, the committee received updates on:

• certification of Full Field Digital Mammography facilities;

• facility satisfaction survey; and

• current facility inspection findings.

NEXT

NEXT (Nationwide Evaluation of 

X-ray Trends) is a collaborative 

State-Federal survey program 

conducted by the Conference of 

Radiation Control Program 

Directors (CRCPD) and FDA. 

NEXT is the sole mechanism in 

the United States for acquiring 

and updating nationally 

representative data on medical xray exposures, image quality, and 

related clinical practice. Hands-on training for NEXT x-ray surveyors at the 

National Naval Medical Center in Bethesda, Maryland

Goals

1. Develop standardized test protocols and imaging phantoms for a variety of 

x-ray examinations and train State radiation control personnel in their use.

2. Determine the average radiation dose and image quality from representative 

clinical x-ray examinations in the U.S.

3. Monitor trends in patient dose, image quality, and relevant clinical factors.
OHIP FY2001 Annual Report, page 28

NEXT Annual Surveys

Survey 

Year

Type(s) of X-ray 

Examination (N = 

no. of facilities 

surveyed) FY2000 Accomplishments

1995 Abdominal and 

Lumbo-sacral spine 

radiography 

 N=204 (abdomen)

 N=319 (l-s spine)

Tabulation and graphical 

analysis of data completed, 

reviewed and currently in press 

by CRCPD. 

1996 Upper 

gastrointestinal 

fluoroscopy

 N=352

Analysis completed for undertable x-ray tube systems; draft 

data summary completed.

1997 Mammography*

 N=7,676 (1995)

 N=10,746 (1996)

 N=11,086 (1997)

Published major study in 

Radiology on mammography in 

the 1990s in the U.S. and 

Canada.

1998 Pediatric radiography

 N=387

Surveys, data entry and 

preliminary analysis completed.

1999 Intraoral 

cephalometric, and 

panoramic dental 

radiography

 N=342

Surveys completed, data 

entered, and analysis 

proceeding.

2000 Computed 

tomography (CT)

Survey protocols modified to 

collect data on fluoroscopic 

CT**; incorporates major 

improvements in survey 

methodology; data analysis 

proceeding.

2001 Adult chest 

examination

Previously surveyed in 1994, 

the 2001 survey will include 

procedures for new digital 

imaging systems and flat panel 

systems, draft protocol 

completed, training dates set.

2002 Adult Abdomen and 

Lumbosacral Spine

Repeat of survey conducted in 

1995. Surveyors will be 

equipped with laptop software 

that will perform all 

calculations previously done by 

hand.

* the data used in the NEXT analysis were obtained from facility 

inspections performed under the Mammography Quality Standards 

Act.

**There have been reports in the literature that prolonged 

irradiation during fluoroscopic CT may lead to patient skin injury. 

The modified protocol will collect quantitative data on the 

prevalence of this procedure and associated patient exposure.

CRCPD’s NEXT

Committee serves as the 

steering and coordinating 

group for the program, 

exercising general 

oversight and providing a 

cadre of State radiation 

control staff who conduct 

the annual surveys. OHIP 

provides scientific and 

technical support for all 

phases of NEXT. This 

support includes training 

of surveyors, including 

presentations from CDRH 

staff on new technologies 

and survey procedures 

and hands-on surveyor 

training at local clinical 

facilities. 

The NEXT program 

represents a twenty-seven 

year partnership between 

FDA and the States. 

Since 1998, NEXT

training for State 

surveyors has been 

partially supported by the 

American College of 

Radiology through 

funding to the CRCPD.

Annual Surveys

Under NEXT, the surveys for 

a given year are directed at a 

single x-ray procedure and are 

conducted in a national cross 

section of clinical facilities. 
OHIP FY2001 Annual Report, page 29

Thus, the survey results for a given year represent a statistically valid “snapshot” 

of x-ray exposure and related factors for that examination in the U.S. The table 

on the previous page shows the status of the 1995 through 2002 NEXT surveys. 

During each survey, specific information is collected, including radiographic 

technique factors, patient x-ray exposure, x-ray beam quality, image quality, 

film processing quality and darkroom fog.

Choosing a different x-ray examination from year to year provides data on a 

variety of radiographic procedures while minimizing the workload during any 

one year. By repeating NEXT surveys for a particular x-ray examination every 

few years, the data can be used to identify trends or changes over the course of 

time.

NEXT Survey Results

OHIP prepares a comprehensive report on a given year’s data that includes 

statistical tabulations and graphical summaries. These reports are then published 

by the CRCPD without conclusions or other analyses in order to make the 

reports widely available and as timely as possible. OHIP also publishes 

interpretive analyses of NEXT data in peer-reviewed scientific, technical, and 

medical journals. 

During FY 2001, OHIP gave presentations at several professional meetings 

including the FDA Science Forum, the annual meeting of the American 

Association of Physicists in Medicine (AAPM), and the annual meeting of the 

Radiological Society of North America (RSNA). Of special interest to the 

professional community were the results of the 2000 survey of computed 

tomography (CT). This modality has seen much technological advancement in 

the past decade as well as broader applications that have renewed concern about 

patient exposure safety. 

The applications of NEXT data and their impact are illustrated in the figure on 

the next page. Data points through 1992 were generated from NEXT surveys 

supplemented with information from the literature. The data since 1995 has 

been collected using MQSA inspection data. 

The results of the NEXT mammography surveys identified concerns with patient 

dose and image quality. These were factors in ACR’s development of its 

Mammography Accreditation Program in 1988 as well as FDA’s MQSA 

regulatory program in 1992. The MQSA inspection uses the protocol that had 

been developed in the NEXT program for determining the radiation dose and 

phantom image quality score.
OHIP FY2001 Annual Report, page 30

As a result of the NEXT

program and these ensuing 

developments, the 

radiation dose women 

receive from 

mammography is 

generally lower and the 

image quality better than 

at any other time since we 

began recording such 

information. Other data 

collected during these 

surveys show marked 

improvement in darkroom 

conditions, also contributing to improved image quality. While patient 

dose has been increasing slightly since 1995, that increase is primarily 

associated with changes in technical measures to improve image quality. 

Overall, NEXT has established baseline data and long-term trends for 

seven diagnostic examinations. These data:

• provide a standard of practice against which facilities can compare 

their radiation levels in order to maintain safe and state-of-the-art 

radiation levels (It is a common practice for many State x-ray 

surveyors to provide x-ray facilities with a brochure so that the 

facility can compare its x-ray survey results with the NEXT data.).

• have been used as a standard for comparison during inspections by 

the Joint Commission on Healthcare Organizations (JCAHO); 

• are currently being adopted by the American Association of 

Physicists in Medicine (AAPM) and the ACR as reference values 

for standards of practice in patient radiation exposure.

72 76 80 84 88 92 96 00

0

2

4

6

8

10

12

14

Phantom Score

 Mean Glandular Dose

Dose (mGy)

Year

5

6

7

8

9

10

11

12

13

14

 Phantom Score

 (w/o artifact subtraction)

Average patient dose and phantom image quality 

scores during mammographic examinations.
OHIP FY2001 Annual Report, page 31

TEPRSSC 

The Technical Electronic Product Radiation Safety Standards Committee 

(TEPRSSC) is an important advisory committee to CDRH and FDA. 

Established under the Radiation Control for Health and Safety Act of 1968, 

TEPRSSC is charged with providing advice and consultation to the 

Commissioner of Food and Drugs on the technical feasibility, 

reasonableness, and practicality of developing performance standards for 

electronic products. TEPRSSC may also recommend electronic product 

radiation safety standards to the Commissioner. 

FDA has performance standards for lasers, sunlamps, microwave ovens, 

ultrasound medical equipment, and diagnostic x-ray systems. In addition to 

these existing standards, FDA has the authority to promulgate mandatory 

safety standards for a wide array of products for which mandatory standards 

do not exist, such as cellular telephones and x-ray people scanners.

OHIP provides the Executive Secretary for the committee as well as 

programmatic support. Summaries of recent TEPRSSC meetings are 

available on our website. In May 2001, the 28th Annual Meeting of 

TEPRSSC convened to discuss important health and safety issues associated 

with:

• digital medical x-ray modalities such as digital radiography, 

computerized radiography, and computed tomography;

• the use of ionizing radiation to scan people for concealed 

weapons and other contraband; 

• cellular telephones; 

• the development of sunlamp standards and international 

harmonization;

• proposed rulemaking for lasers;

• proposed amendments for fluoroscopy;

• computed tomography pediatric examinations, dose-index 

display, standardization of nomenclature, tube-current 

modulation, x-ray field limitation, possible regulatory 

approach, and whole-body screening;

• non-medical radiation products such as television sets, 

microwave ovens, and lasers. 

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OHIP FY2001 Annual Report, page 32

Federal Facilities Inspections

OHIP manages a Federal Facilities Inspection program that provides 

radiation protection services to diagnostic x-ray facilities run by various 

federal agencies. The federal agencies participating in this program 

include:

• Department of Justice (Bureau of Prisons);

• U.S. Coast Guard; and

• NASA (National Aeronautics and Space Administration).

CDRH also has an Interagency Agreement with the Indian Health Service 

to provide survey equipment, calibration services, training, and assistance 

with technical issues related to radiation use and control. 

OHIP coordinates with FDA’s Office of Regulatory Affairs (ORA) to 

conduct radiation surveys in all of these facilities. ORA staff, either the 

FDA Regional Radiological Health Representatives (RRHRs) or FDA xray auditors, perform the actual surveys. The ORA staff have special 

training and experience in radiation physics and are qualified to provide 

facilities with information on how to reduce radiation exposure during 

medical radiographic procedures. This information ranges from 

recommending x-ray techniques to methods for optimizing film 

processing and enhancing image quality. The RRHRs are also available 

for phone consultation to assist facilities with other problems that might 

arise in their x-ray facilities.

OHIP provides administrative support and overall coordination for the 

program. This support includes negotiating Interagency Agreements with 

the participating federal agencies. These Agreements fund FDA’s 

program implementation for the purchasing and inventorying of survey 

Goals

2. Assess federal facility compliance with the Presidential Directive of 1978, 

“Radiation Protection Guidance for Federal Agencies for Diagnostic X-rays.” 

3. Educate facility personnel in methods to reduce radiation exposure while 

improving image quality.
OHIP FY2001 Annual Report, page 33

equipment and supplies, and for conducting surveys. Each radiation survey is 

followed up with a report to the x-ray facility and to the headquarters liaison for 

that federal agency. The report contains test results, cites deficiencies if any, 

and makes recommendations for improving the quality of the diagnostic x-ray 

services at the facility.

Approximately 90 surveys were completed in FY2001. Most were conducted in 

the Bureau of Prisons or U.S. Coast Guard facilities. Almost all surveys 

recommended minor changes that resulted in a reduction in unnecessary 

radiation exposure and improved image quality.

All of the participating federal agencies review these reports and require their xray facilities to make changes and improvements as recommended by the FDA. 

At Bureau of Prisons facilities, these reports become an integral part of the 

records reviewed by auditors from the Joint Commission on Accreditation of 

Healthcare Organizations when they evaluate and accredit the facility. 

Radiation Safety

In carrying out its regulatory science mission, CDRH 

uses laboratories that employ radiation-emitting 

products and radioactive materials. CDRH’s 

Radiation Safety Officer (RSO) is a member of 

OHIP’s staff. The RSO is responsible for CDRH’s 

radiation safety program. This includes protecting

the health and safety of all employees and assuring

that CDRH complies with all government regulations 

on the safe use of radioactive materials. 

During FY2001, the RSO and OHIP accomplished the following:

 

• conducted quarterly surveys of all radiation laboratories, annual audits of all 

radiation programs and licensees and unannounced surveys of CDRH 

radiation laboratories;

Goals

1. Assure the safety of employees and contractors working in CDRH radiation

laboratories.

2. Assure CDRH compliance with federal regulations governing the use and 

control of radiation-emitting electronic products and radioactive materials.
OHIP FY2001 Annual Report, page 34

• calibrated 22 radiation survey instruments on a semi-annual basis;

• conducted the annual training required for all licensed materials users; 

• facilitated and chaired quarterly radiation safety committee meetings.

During FY2001, there were no incidents that resulted in harm or 

overexposure to individuals working in CDRH laboratories. Our laboratory 

inspections and audits also indicate that we are meeting our goals. Where 

minor problems were identified, corrective actions have been taken and will 

be monitored during future reviews.

The improvements in CDRH’s radioactive waste practices, begun in 

FY1999, were particularly important accomplishments. As shown in the 

following table, they have led to continuing, significant reductions in the 

amounts of hazardous materials stored by CDRH. These practices have 

resulted in improved radiation safety, better accountability of radioactive 

materials, reduced workload for monitoring sealed radiation sources, and 

reduced costs for physical storage. 

REDUCING USE ERROR

People make errors all the time – it’s an aspect of being human. Errors 

made while using medical devices can lead to hazards which can impact 

patients, family members, and healthcare providers. Hazards associated 

with device use are a common and serious problem. Evidence from 

 

2

 “Decay-in-Storage” – is a standard practice to store containers of short-lived radioactive waste until the 

radioactive materials have decayed so that the waste can be released as non-radioactive.

3

 Does not include generally licensed sources that do not require NRC (Nuclear Regulatory Commission) 

approval.

Radioactive Waste and Sealed Radiation Sources 

Stored by CDRH

FY1997 FY1998 FY1999 FY2000 FY2001

Containers of liquid radioactive 

waste

30 40 6 1 1

Sealed Drums of dry radioactive 

waste

3 3 0 0 0

Drums of “Decay-in-Storage” 

waste2 3 3 1 1 0

Sealed radiation sources3200 200 3 3 3
OHIP FY2001 Annual Report, page 35

researchers suggests that the frequency and consequence of hazards 

resulting from medical device use error far exceed those arising from 

device failures. Therefore, it is essential to ensure safe and effective 

device use if hazards are to be controlled effectively.

FDA recognizes that most use errors with medical devices are not 

“inevitable human error.” Rather, they are largely influenced by device 

design and device labeling. OHIP seeks to promote the safe and effective 

use of medical devices through our Human Factors program, labeling 

efforts, and patient safety activities. 

Human Factors

Human Factors (HF) is a science devoted to 

the interaction of people and equipment. 

“Human Factors,” “human engineering,” 

“usability engineering,” and “ergonomics” are 

often used interchangeably. In the field of 

medicine, the objective of Human Factors is 

to improve human performance and reduce 

the likelihood of use error and patient injury.

Human Factors has been used extensively by 

the military, the transportation industry and in some consumer areas. It is 

now being applied to address use error problems in medicine. Human 

Factors analysis and testing should be applied throughout the entire lifecycle of a medical device. Our Human Factors efforts impact on the 

Center’s premarket, postmarket, and field-inspection regulatory missions. 

We assisted the Center’s Office of Device Evaluation by providing several 

Human Factors reviews for PMA and 510(k) devices.

Goals

1. To support the medical device industry’s successful application of human 

factors principles in order to reduce medical device use error.

2. To expand the science base and continued advocacy for the effective 

communication of labeling information to patients and healthcare 

professionals.

Safe & 

effective 

Unsafe or

ineffective

(Use Error)

Use Environment

• Light, Noise

• Distraction

• Motion/Vibration

Device User

• Knowledge

• Abilities

• Expectations

• Limitations

Device

• Operational

 requirements, procedures

• Device complexity

• Specific user interface characteristics

HF Considerations Use

Device

 Use
OHIP FY2001 Annual Report, page 36

• Guidance: In July 2000, we issued a final guidance 

document, Medical Device Use Safety: Incorporating 

Human Factors Engineering into Risk Management. This 

document has received positive feedback from industry 

representatives. Its content provided the basis for the 2001 

teleconference: "Integrating Human Factors Engineering 

into Medical Device Design and Development." Recent 

HF guidance efforts include a HF section of the new 

guidance (being written) for glucose monitors which 

contains specific considerations for glucose monitors. 

This effort also included the incorporation of HF 

perspectives into the software validation component of the 

glucose monitor guidance document.

• Teleconference: On February 14, 2001, we broadcast a 

live, interactive satellite teleconference: Integrating 

Human Factors Engineering (HFE) into Medical Device 

Design and Development. The audience included risk 

managers, device manufacturers, and other health care 

providers. The focus was the role of the medical device industry 

in reducing errors involving medical device use, a.k.a. “use 

error”. The teleconference included two panels. The first panel 

was composed of representatives from CDRH who discussed the 

regulatory implications of HFE and the extent to which human 

factors is considered as part of the overall review performed by 

CDRH. The second panel was composed of experts on HFE 

from the medical device industry. This panel discussed 

integration of HFE into design and development processes for 

medical devices for the purpose of making devices safe for 

users. At the end of the teleconference, panelists responded to 

questions from a nationwide audience. Questions that were not 

answered at the time of the teleconference are posted on our 

website (link on previous page).

• Research - PROUD 2000: The Prioritization and Reduction of 

Use Error in Devices 2000 project is part of OHIP’s overall 

strategy to address deaths and injuries resulting from the use of 

medical devices. There is still much to be learned before we can 

fully understand use error with medical devices. In 2000, we 

completed the first phase in which we interviewed Nurses and 

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1497.html

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101100.html

Human Factors 

Considerations can 

result in Medical 

Devices with:

• Intuitive 

operation and 

low reliance on 

manuals; 

• Easy-to-read 

displays;

• Easy-to-use 

controls; 

• Positive and safe 

connections;

• Effective alarms; 

and

• Easy repair and 

maintenance.
OHIP FY2001 Annual Report, page 37

other actual device users. We collected information on problematic 

devices, methods for analyzing device use error, organizational 

influences on use error, and overall issues that affect use error (i.e., 

training, staffing, workload issues). During 2001, to coincide with the 

IVD TPLC effort, the next phase of PROUD began with a series of 

discussion/focus groups consisting of glucose meter users. The results 

of this undertaking were directly applicable to the recent HF guidance 

contributions for glucose monitors, and ultimately provided useful 

information to the public about glucose meter use considerations via a 

diabetes web site. The next activity will involve discussion groups 

with clinical engineers regarding use problems with devices used in 

hospitals. 

• National Standards: OHIP played a key role in the development of 

the American National Standard ANSI/AAMI HE74:2001, Human 

factors design process for medical devices published in 2001. This 

standard will be given FDA recognition and will serve as a human 

factors engineering design guidance for medical devices. 

• International Standards: OHIP is leading the development of an 

international standard (IEC 60601-1-6, collateral standard: Usability: 

Analysis, test and validation of human factors compatibility) that 

describes how manufacturers must carryout design activities to 

address the needs of the device users to minimize dangerous error. 

The 1st Committee Draft was circulated for national committee 

comments in the Spring of 2001. This standard serves as the primary 

basis for the international standard IEC 60601-1-6, collateral standard: 

Usability: Analysis, test and validation of human factors compatibility 

which is currently being developed.

• Human Factors Brochure: In FY2001, OHIP updated the Human 

Factors Brochure and distributed it widely at professional meetings. 

The brochure briefly introduces Human Factors in medicine, lists 

CDRH Human Factors activities, and gives other information 

resources. All of the information from the brochure is available 

from our webpage.

http://www.fda

P

.gov/cdrh/hum

fac/hfbrochure

.html
OHIP FY2001 Annual Report, page 38

Labeling

Improved patient labeling on medical 

devices allows the patient or caregiver to 

better understand both instructions for 

use and risk-benefit information. Our 

accomplishments included:

• We review patient labeling for all 

new Premarket Approval (PMA) 

submissions and also for non-PMA 

submissions if CDRH’s Office of Device Evaluation thinks that patient 

labeling needs review. This was the fifth year that OHIP performed 

these reviews. In cases where patient labeling is not submitted, OHIP 

reviewers determine whether patient labeling will contribute to reducing 

use error or allow the patient to make a more informed choice 

concerning their healthcare. During FY2001, we reviewed 141

submissions. 

Of the 141 reviews, 63%

of submissions contained 

patient labeling. 23% did 

not contain patient 

labeling, but we 

recommended that patient 

labeling be written. 14%

did not have patient 

labeling and we did not 

recommend labeling for 

the patient.

23

All Product Reviews*

October 2000 -- October 2001

Patient Labeling 

Provided

No Patient Labeling 

Provided - BUT 

Recommended

No Patient Labeling 

Provided - NOT 

Recommended

*Includes original submissions, supplements, and requests for repeat reviews.

63%

14% 23%
OHIP FY2001 Annual Report, page 39

• A Draft Guidance on Medical Device Patient Labeling was

issued. In April 2001, we issued a guidance document titled, 

“Guidance on Medical Device Patient Labeling; Final Guidance 

for Industry and Reviewers”. The guidance can be found at the 

website to the left of this page. It is designed to assist 

manufacturers in their development of patient labeling to help 

make it understandable to and usable by patients (or family 

members or other lay persons caring for patients). The guidance is 

also designed to assist Center reviewers in their review and 

evaluation of medial device patient labeling. This guidance offers: 

ÿ A suggested sequence and content for patient labeling;

ÿ Information on readability and writing for increased 

comprehension;

ÿ Principles to apply to the appearance of text and graphics; 

and

ÿ Guidelines on pretesting patient labeling with the target 

audience.

Patient Safety

During 2001, OHIP participated in the Errors Workgroup and the 

Patient and Consumer Information Working Group of the Quality 

Interagency Coordinating Committee (QuIC) on patient safety. The 

QuIC is coordinated by the Agency for Healthcare Research and 

Quality. 

The Patient and Consumer Information Working Group of the QuIC 

finalized the brochure “5 Steps to Safer Health Care” in English 

(www.fda.gov/opacom/factsheets/5steps.html) and Spanish 

(www.ahcpr.gov/consumer/cincorec.htm). This publication is 

designed to help patients actively participate in their health care. 

Specifically, the five steps to follow are:

ÿ Speak up if you have questions or concerns.

ÿ Keep a list of all the medicines you take.

ÿ Make sure you get the results of any test or procedure.

ÿ Talk with your doctor and health care team about your options.

ÿ Make sure you understand what will happen if you need surgery.

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ENGLISH
OHIP FY2001 Annual Report, page 40

The Errors Working Group tracked the progress of the participating QuIC 

agencies in completing the patient safety action items identified in the 

Institute of Medicine Report on Medical Errors and coordinated a response 

to the President on the status of the action items. CDRH prepared summary 

updates on the CDRH action items related to adverse event reporting, human 

factors, and patient education. 

Additionally, as part of CDRH’s interest in increasing the 

awareness of medical students about patient safety issues with the 

use of medical devices, a medical school curriculum content 

outline was developed and piloted with medical students under a 

grant to the Cleveland Hospital Foundation. CDRH is pursuing 

additional partnerships to further develop the curriculum model 

into an interactive educational program or web-based program 

that can be utilized in the clinical setting by a variety of healthcare 

practitioners.

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SPANISH
OHIP FY2001 Annual Report, page 41

REGULATIONS AND GUIDANCE

OHIP plays an essential role in the development of all CDRH 

regulations and Federal Register documents, as well as in the 

management of Good Guidance Practices.

Regulations

In FY2001, OHIP lawyers and paralegal staff were instrumental in 

allowing CDRH to:

• meet all statutory requirements associated with implementation of 

the FDA Modernization Act of 1997 (FDAMA);

• respond to 16 citizens petitions, with no overdue petitions; and

• publish 46 Federal Register documents. Some of the most 

significant documents being finalized include: 

ÿ Postmarket Surveillance. This final rule establishes

procedures for FDA and manufacturers on the postmarket 

surveillance requirements. This was CDRH’s first “Plain 

Language” rule (see below) and it was the first rule for 

which CDRH is accepting comments on the Internet.

ÿ 510(k) -FOI rule (Freedom of Information). We are 

finalizing a proposed rule to require submitters of premarket 

notifications to send FDA a version of the 510(k) with trade 

secret and confidential commercial information deleted. 

This rule, if implemented, would save FDA the time of 

deleting this information when responding to FOI requests.

Goals

1. To manage all aspects of CDRH’s regulations development process.

2. To serve as regulatory experts on CDRH teams addressing medical device or 

radiological health issues.

3. To coordinate the development, review, and submission of all Federal 

Register publications for CDRH, including citizen petitions.

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OHIP FY2001 Annual Report, page 42

ÿ States as Certifiers. FDA has finalized a rule that would transfer 

aspects of FDA’s role as a Certifier of mammography facilities to 

qualified States. The rule fully implements a provision in the 

Mammography Quality Standards Act (MQSA).

ÿ Mass Reclassification. CDRH issued a final rule to reclassify 

28 class III devices into class II. This is a major step toward 

completion of the review of the pre-1976 Class III devices.

ÿ Apnea Monitors. CDRH is finalizing a 510(k) guidance 

document for apnea monitors and is making this guidance 

document a special control for these devices.

ÿ Tracking Amendments. CDRH issued a rule to implement the 

FDAMA amendments to the tracking provisions of the Federal 

Food, Drug, and Cosmetic Act.

The regulation workload in FY2001 was consistent with that of 

previous years. In order to maintain a high level of output and 

quality, OHIP continued to implement improvements and changes 

identified through CDRH-wide reengineering of the regulation 

process.

Good Guidance Practices

Good Guidance Practices (GGPs) are FDA’s policies and procedures 

for developing and issuing guidance documents. Guidance documents 

describe FDA’s interpretation of, or policy on, a regulatory issue. 

They are typically prepared for FDA staff, applicants/sponsors and/or 

the public. The GGP policy standardizes the development process for 

guidance documents, provides opportunities for public comment, and 

clarifies the use of guidance documents. Each FDA Center is charged 

with implementing its own GGPs. OHIP leads implementation, 

administration, and monitoring of GGPs within CDRH.

Goals

1. To provide coordination and leadership for CDRH’s GGP process.

2. To work with CDRH’s Office and Division GGP contacts to ensure that CDRH 

guidance documents comply with the GGP regulation.

3. To assure easy access to CDRH guidance documents over the Internet.
OHIP FY2001 Annual Report, page 43

In FY2001, OHIP:

• Created and updated a comprehensive database of all 

guidance documents issued by CDRH – currently, more than 

642 guidance documents prepared under GGPs. 

• Worked with CDRH’s Office of Systems and Management 

to provide a searchable version of the database available on 

the CDRH webpage. This database can be viewed on the 

website to the left.

• Updated and revised the Standard Operating Procedures 

(SOP) Manual for GGPs, providing CDRH authors with 

detailed instructions, templates and checklists.

• Worked with CDRH’s GGP contacts to publish an annual 

listing of all guidance documents.

Plain Language

On June 1, 1998, the President issued a directive that the federal 

government's writing must be in plain language. Basically, plain 

language means that our documents must be clear and easy to read.

Within CDRH, OHIP is responsible for coordinating the implementation 

of plain language in all of our written communications, including 

regulations and guidance documents.

Goals

1. To assure that CDRH’s written communications are clear and easy to read.

2. To provide advice and assistance to CDRH staff on writing in Plain Language.

Language.

http://www.fda

P

.gov/cdrh/ggp

main.html
OHIP FY2001 Annual Report, page 44

During FY2001, OHIP:

• Continued to sponsor plain language and writing/editing courses for 

CDRH staff – since these classes were first offered in FY1999, more 

than 325 staff have participated in classes for:

ÿregulations writers, 

ÿletter writers, 

ÿsupport staff, 

ÿreviewers and non-reviewers;

• Edited documents and webpages to assure the language used is clear 

and simple. Examples of these include:

ÿ Metal Detectors and Other Security Systems

We edited a document about the safety of metal detectors and 

other security systems found in airports and building entrances. 

The document answers questions about safe passage through 

security systems by the public and by pregnant women. It also 

discusses the risks of electromagnetic interference with 

implanted medical devices such as pacemakers, implantable 

cardioverter defibrillators, and infusion pumps.

ÿ Wireless Telephones

We collaborated with other CDRH offices and the Federal 

Communications Commission to design and develop a web site 

to provide information about wireless telephones. This web site 

evaluates health and safety concerns about radiofrequency 

energy, wireless phones, and wireless base stations.

• Continued to assure that new CDRH documents are written in plain 

language and that plain language is incorporated into existing CDRH 

documents as they are updated and revised.

• Provided plain language review for 55 one-page summaries written by 

CDRH about newly approved and cleared devices which include new 

and emerging technologies.
OHIP FY2001 Annual Report, page 45

FDAMA

OHIP serves as the CDRH coordinator for implementation of the FDA 

Modernization Act of 1997 (FDAMA). Each of the CDRH Offices is 

committed to implementing the provisions of FDAMA, as evidenced by 

a record of:

• more than 24 final guidance documents and eight final rules;

• three Reports to Congress;

• routine updates to the list of recognized consensus standards;

• implementation and proposed expansion of the Accredited 

Persons Review Program (discussed elsewhere in this report); 

and

• implementation of the Least Burdensome provisions of FDAMA.

Throughout all of these efforts, OHIP has provided support for 

regulations and guidance development as well as extensive training and 

education for CDRH staff on FDAMA provisions. The Least 

Burdensome Provisions of FDAMA were the topic of CDRH’s first 

webcast.

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OHIP FY2001 Annual Report, page 46

CDRH STAFF COLLEGE 

OHIP provides all CDRH employees with comprehensive 

professional and technical training through our Staff College. Our 

products include classroom training, live satellite teleconferences, 

webcasts, online coursework, and a variety of seminars and lectures. 

Training Highlights 

During FY2001, we provided CDRH employees with extensive 

training opportunities, including: in-depth training on scientific and 

technical issues; CDRH programs and policy; the use of plain 

language in all CDRH communications; and training in 

communication, interpersonal, and professional development skills 

(see next page for examples). This training was presented in a variety 

of settings and formats:

• Over 100 different courses were presented for more than 2,800 

“students.”4 Depending upon the topic and training objectives, 

individual courses can require a commitment of from four to forty 

hours. The longer courses may spread over a period of several 

weeks.

 

4

 There were approximately 1,050 CDRH employees in FY2001. Individual employees take advantage of 

several training opportunities during the year. Therefore, the number of “students” or “attendees” is greater 

than the number of employees.

Goals

1. To partner with all CDRH Offices in offering high quality, practical training 

solutions that meet CDRH’s evolving needs and priorities.

2. To provide individual employees with management, professional development 

and scientific/technical training opportunities that enhance their job 

performance and maximize their career potential.
OHIP FY2001 Annual Report, page 47

• Fifty-six high quality, 

seminars were held in 

FY2001. Over 1,700

employees attended 

these seminars. “Staff 

Updates” are scheduled 

on a flexible basis to 

address current or 

upcoming issues. 

“Science Grand 

Rounds” are held 

monthly to keep CDRH 

staff up-to-date on the 

latest medical device 

and radiation issues. 

This year, we added 5 

Radiological Seminars 

and 1 Law Seminar 

Series. The speakers at 

our seminars are 

national and 

international experts 

from FDA, other 

government agencies, 

universities, and from 

the medical device 

industry.

• Staff College continued 

to evaluate the impact 

of training on job 

performance. During 

FY01, impact surveys 

were conducted on 

several courses. The 

survey results indicate 

that classroom learning 

is applied to Center 

work products.

Examples of FY2000 Training

for CDRH Staff

• Home/Self Care Technology: This one-day course 

addressed home/self care devices; one of the most important 

emerging technologies/trends identified in the Future Trends 

Study.

• Risk Management: This comprehensive course in Risk 

Management for CDRH Staff also address HACCP principles. 

Internal, industry and academic faculty delivered the course.

• Epidemiology: In conjunction with OSB’s Epidemiology staff, 

a new, semester-long course in Epidemiology was offered Fall 

2000.

• Anatomy and Physiology: This 8-week course was held for 

the first time in FY’01 and provided staff with a comprehensive 

overview of human anatomy and physiology.

• Human Factors: In partnership with OHIP/DDUPSA, this 

course was developed as a refresher course in Human Factors.

• Biocompatibility Case Studies: We continued to offer 

quarterly updates to the previously held 12-week course on 

biocompatibility, which was presented in Spring 2000. The 

updates give reviewers the opportunity to apply and reinforce 

knowledge gained about specific biocompatibility testing in the 

review and evaluation of medical device submissions.

• Surfaces in Biomaterials: As a precursor in Biomaterials 

course scheduled for FY’02, the annual Surfaces in Biomaterials 

foundation Hemocompatible Surfaces Workshop was broadcast 

to CDFH employees via videoconferencing in August 2001.

• Designing Cardiovascular Devices: Science Technology 

and Applications was offered for the first time in June 2001.

• FOIA & Privacy Act Briefing updated participants with 

knowledge and understanding of the FOIA and Privacy Acts.

• Plain Language/Technical Writing: A total of 114 

employees attended our FY01 offerings. Three sessions were 

offered of a new course on Reviewing and Editing the Writing of 

Others for a total of 88 employees.

• SkillSoft Training: a web-based, self-directed learning 

program with over 400 online courses was launched Centerwide in FY01.

• OHIP offered an extensive program of over 100 video 

playbacks of recently recorded training and educational 

programs. The CDRH Learning Channel now has programming 

continuously available. 

• Pathways Program for Administrative & Support Staff: 

We continued to administer and market this program, which

recognized its first Graduate in Spring 2001. The following 

courses were offered specifically for the Pathways program: 

Achieving Professional Goals Together, Teaming Up for Success, 

and Managing Support Staff. 
OHIP FY2001 Annual Report, page 48

• We continued to expand science-related satellite and audio 

teleconference offerings. Sixteen satellite teleconferences were offered 

and attended by over 300 CDRH employees. 

• We continued to utilize CenterNet Live. 

This uses webcast technology to bring 

important seminars, lectures and 

presentations to every desktop computer 

in CDRH. Webcasting provides every 

CDRH employee with the flexibility to 

participate in important events “live” or 

at a later date through our playback 

schedule.

• CDRH maintained availability of offerings from SkillSoft Corporation’s 

Critical Skills Library. This program has been a great success and is 

frequently used as pre-assigned reading for many of our courses.

360° Training Program

The Staff College Training team continues to implement a “360 degree 

Training Program” in CDRH. The program has ensured that courses are 

more rigorously designed, developed, delivered, and assessed to ensure 

their quality and relevance to program goals. During FY’01, the training 

team continued to focus on needs assessment, training impact 

assessment, training transfer, evaluation, Staff College 

performance/evaluation measurement criteria, and benchmarking.

Electronic Course Evaluations

The pilot of electronic course evaluations conducted in FY’01 has been 

extremely successful with positive feedback from respondents throughout 

CDRH, as well as improved productivity of Staff College employees. 

OHIP will continue to conduct online course evaluations, impact surveys, 

and needs assessments and explore new ways to make use of this 

technology to improve the efficiency of CDRH training operations.
OHIP FY2001 Annual Report, page 49

CDRH Manager Core Competencies and Learning 

Pathways

During FY’01, OHIP’s Staff College played a lead role in addressing the 

Center’s Strategic goal of becoming a Magnet for Excellence. Reaching 

this goal involves a proposal of developing and establishing core 

competencies and learning pathways for CDRH managers. The Magnet 

for Excellence Goal Group and nominated supervisors from throughout 

the Center continue to work on the development of this project. The

project involves identifying the core competencies applicable to CDRH 

managers – basic knowledge and management/supervisory skills needed

to excel and make CDRH a “magnet for excellence.” The group will also 

develop “learning pathways” (a suggested core curriculum of courses) 

that build the knowledge and skills needed to address those 

competencies.

CDRH Mentoring Program

During FY’01, OHIP’s Staff College lead the Magnet for Excellence 

project plan proposal of developing a formally structured mentoring 

program for new supervisors. A subgroup of the Magnet for Excellence 

Goal Group, along with nominated employees throughout the Center,

engaged in work to develop this project with guidance from an external 

consultant. The program will help develop a skilled and talented pool of 

employees whose competencies align with the CDRH strategic mission.

Workplace Assessment

In FY’01, in conjunction with a subgroup of the Magnet for Excellence 

Goal Group, OHIP’s Staff College assisted with the logistical aspects for 

an external consultant to conduct a workplace assessment survey to be 

conducted during FY’02. When the survey is completed, CDRH 

managers will receive feedback on survey results about their 

effectiveness in helping to build and to retain a strong workforce. OHIP 

will continue to assist the external consultant with coordinating 

workshops for managers as a follow-up to the FY’02 survey results.
OHIP FY2001 Annual Report, page 50

TELECONFERENCE/VIDEO PRODUCTION

OHIP operates a broadcast 

quality television studio on 

behalf of CDRH and FDA. 

The studio is a uniquely 

powerful tool for outreach on a 

wide variety of topics. The 

primary medium for outreach 

has become production and presentation of “live teleconferences,” 

although we continue doing videotaped programming on a limited 

basis. 

The television studio continues to provide excellent “value” to CDRH 

and FDA. Studio operations and capital expenditures, other than 

personnel costs, are completely funded by chargebacks to the other 

components of FDA and other government agencies sponsoring the 

programming. As a result, during FY2001;

• CDRH programming was produced with minimal program 

dollars. 

• The same facilities and equipment used for teleconferences 

and video production were available to CDRH for other 

purposes:

ÿ we provided technical video support forCentersponsored medical device panel meetings; 

ÿ we provided video documentation of critical CDRH 

meetings and training events; and

ÿ we provided 8 hours of mission-related programming every day to 

CDRH employees via the CDRH fiber-optic network, including 32 

educational and training programs received live via satellite and 

delivered simultaneously.

Goals

1. To provide the infrastructure and expert knowledge needed to effectively use 

audio and video in support of CDRH, FDA and other government public health 

programs.

2. To evaluate, recommend and support new techniques and technologies for 

improved training, education and information exchange.
OHIP FY2001 Annual Report, page 51

Our website for the 

television and video 

services continues to be a 

comprehensive source of 

information regarding our 

television and related video 

services. Developed in 

cooperation with CDRH’s 

Office of Systems and 

Management, it provides 

up-to-date information on 

television programs 

currently in production, 

programs scheduled for broadcast, and opportunities to secure programs 

previously broadcast. It also provides other PHS agencies with a greater 

understanding of the facilities and services available to them.

Another important feature of our website is a “program calendar” that 

provides information about, and serves as a marketing tool for, individual 

CDRH/FDA teleconferences. The program calendar: 

• notifies a potential audience of a scheduled event;

• creates a temporary data base of downlink sites; 

• provides answers to frequently asked questions related to downlink 

operations; 

• allows for interactive exchange both before and after the distance 

learning broadcast; and 

• results in a database that significantly enhances our ability to 

accurately target marketing information for all programming 

activities. 

Also during FY2001:

• We used the enhanced ability of our facility and the expertise of 

our staff to provide new services to CDRH and FDA that allow 

audio and video to be digitized and used as streaming media on the 

Web and for the production of CD copies of television 

productions.

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OHIP FY2001 Annual Report, page 52

• A new series of monthly educational and informational programs 

aimed at health-care providers has been instituted in concert with 

other CDRH components. The program, “FDA Patient Safety 

News”, is currently distributed to four medical networks reaching a 

combined audience of 4,700 hospitals. Each program features

stories on new medical devices recently approved for by FDA, 

recent FDA notifications about safety problems with devices, tips 

on protecting patients when using medical devices, and important 

product recalls. The show also features a “Journal Scan” section, 

in which we highlight interesting articles on patient safety in the 

medical literature. Playback schedules and 24/7 network operation 

produce 15,000 airings per month of each title.

• In collaboration with OSM, “FDA Patient Safety News” has its 

own dedicated website where interested persons can review the 

stories that have appeared on the broadcasts, get more information 

on any of the topics we cover in the broadcasts, and report 

problems they’ve encountered with FDA-regulated products 

directly to CDRH. That site is located at fda.gov/cdrh/psn.

• We began a series of monthly broadcasts to all FDA employees 

featuring the Acting FDA Commissioner. This series of programs, 

titled “A Conversation with the Commissioner”, allows timely 

information to be imparted as well as interactive communication 

between the commissioner and any guests appearing on the 

program and the FDA workforce. These programs are also made 

available on the FDA website as archived media for viewing at any 

time from the employee’s desktops.

• DCM facilitated the first ever joint teleconference between FDA 

and NTEU. The success of this collaborative effort generated a 

second teleconference to address union-related issues.

• Plans are currently underway to inaugurate a CFSAN video 

network that will be made available to all employees in the new 

Greenbelt CFSAN headquarters building. This network will 

operate in the same fashion and with identical equipment to the 

current CDRH and CBER fiber channels that are currently 

managed and operated by OHIP.
OHIP FY2001 Annual Report, page 53

• We continue to explore, evaluate and implement new tools and 

technologies that allow information and educational programming 

to be delivered to CDRH employees either individually, in groups 

of varying sizes, interactively, and/or on an “as-needed” basis. Our 

mechanisms of delivery have expanded beyond videotape to 

include CD-Rom, DVD, and streaming media.

• On-location video recordings of lectures, panel discussions, 

training classes, and other informational programs were used in a 

variety of training and learning situations, including rebroadcast to 

all CDRH staff.

• We continued our working partnership with the Office of 

Regulatory Affairs (ORA) to provide training and other 

programming on a wide variety of FDA issues.
OHIP FY2001 Annual Report, page 1

APPENDIX

Publications and Presentations

OHIP’s programs may involve formal publications or presentations in various 

scientific and professional settings. This listing reflects the variety and diversity of 

our programs.

Activities of NEXT – Past, Current, and Future. Presented to the 33rd Annual 

meeting of the Conference of Radiation Control Program Directors, Anchorage, 

Alaska, April 29-May 2, 2001. Companion paper published in Proceedings of the 

33rd National Conference on Radiation Control, CRCPD Publication 01-7, August, 

2001; pg 88. PowerPoint document available at 

http://www.crcpd.org/proceedings.htm. Mary Ann Spohrer, David Spelic.

Breast Implant Risks. FDA Brochure. November 2000. Nancy Leonard, Mary 

Ann Wollerton

CDRH Regulatory Requirements and Quality Systems. 8 Presentations at the 

FDA Medical Device Reuse Workshop; Orlando, FL.; May 10-11, 2001; Joseph 

Puleo; Frederick B. Winston

CDRH Regulatory Requirements and Quality Systems. 8 Presentations at the 

FDA Medical Device Reuse Workshop; Phoenix, AZ.; May 30-31, 2001; Joseph 

Puleo; Frederick B. Winston

Chapter 2, Radiation Safety. Efficacy and Radiation Safety in Interventional 

Radiology, (World Health Organization, Geneva, 2000). P. Shrimpton 

(Rapporteur), C. Sharp (Chairman), D. Mohlkert, V. Neofotistou, H. Schibilla, T. 

Schmidt, S. Stern, R. Veit, and M. Zankl.

Comparison of Photometers in Measuring DICOM Part 14 Conformance. 

Medical Physics, 28, 1248(2001). B. Drinkwine, J. Thomas, M. Loscocco, K. 

Chakrabarti, R. Kaczmarek, I. Ilev, R. Waynant.

Comparison of Photometers in Measuring DICOM Part 14 Conformance. 

Scientific exhibit presented at the 2001 meeting of the American Association of 

Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 

2001 (Abstract), p. 1248. B. Drinkwine, J.Thomas (USUHS), K. 

Chakrabarti, R. Kaczmarek (CDRH), M. Loscocco (JRCAB, Ft Detrick, MD).
OHIP FY2001 Annual Report, page 2

Continual Quality Control Monitoring of High Resolution Diagnostic Monitors. 

Medical Physics, 28, 1248(2001). M. Loscocco, J. Thomas, B. Drinkwine, K. 

Chakrabarti, R. Kaczmarek, D. Davis.

Continuous Quality Control Monitoring of High Resolution Diagnostic 

Monitors. Scientific exhibit presented at the 2001 meeting of the American 

Association of Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 

28, No. 6, June 2001 (Abstract); p. 1248. M. Loscocco (JRCAB, Ft Detrick, MD), 

J. Thomas, B. Drinkwine (USUHS), R. Kaczmarek, K. Chakrabarti, (CDRH) D. 

Davis (Naval Medical Center, San Diego, CA).

Division of Small Manufacturers, International and Consumer Assistance 

(DSMICA) Overview. Presentation at the Association of Medical Diagnostic 

Manufacturers (AMDA) Workshop; Rockville, MD.; April 25, 2001; William 

Sutton

Effect of CNR and SNR on Phantom Image Quality in GE Senographe Full 

Field Digital Mammography System. Medical Physics, 28, 1247(2001). K. 

Chakrabarti, R. Kaczmarek, J. Thomas, B. Drinkwine, M. Loscocco.

Effects of CNR and SNR on Phantom Image Quality in the G.E. Senograph 

2000D FFDM System. Med. Phys. Vol. 28, No. 6, June 2001 (Abstract); p. 1247. 

Scientific exhibit presented at the 2001 meeting of the American Association of 

Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 

2001 (Abstract), p. 1247. K. Chakrabarti, R. Kaczmarek (CDRH), J. Thomas, B. 

Drinkwine (USUHS).

Establishment Registration and Medical Device Listing. CDRH User Facility 

Reporting Bulletin, Issue 34, Spring 2001; Frederick B. Winston

Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety 

Standard for Diagnostic X-Ray Equipment. Poster S3, 2001 FDA Science 

Forum: Science Across the Boundaries, Washington, DC, February 15-16, 2001 

(Abstract no. 189, http://vm.cfsan.fda.gov/~frf/forum01/A189S03.htm; entire 

paper, http://www.fda.gov/cdrh/radhlth/021501_xray.html). S.H. Stern, S.A. 

Tucker, R.M. Gagne, and T.B. Shope, Jr.

Equipment Evaluation and QC Test Requirements for Full Field Digital 

Mammography Systems Invited Presentation at the Digital Mammography 

Workshop. Nov. 15, 2001, University of California, Los Angeles, CA. Published 

in Newsletter of American Association of Physicists in Medicine. K. Chakrabarti.
OHIP FY2001 Annual Report, page 3

FDA Launches a Tool to Create Effective Medical Device Patient Labeling: 

Seeks FDA-Industry Partnership in Its Use. Food and Drug Law Institute Update 

Magazine, Volume 56, Issue 4, Page 13-15. July/August 2001. Silberberg, Paula 

G. 

Global Harmonization. 6 Presentations for the Asian Harmonization Working 

Party; Malaysia; September 6-7, 2001; Christine Nelson; Judy Strojny

Guidance on Medical Device Patient Labeling; Final Guidance for Industry and 

Reviewers. http://www.fda.gov/cdrh/ohip/guidance/1128.pdf. April 19, 2001. 

Silberberg, Paula G. 

Hospital Bed Safety Work Group: Highlights. Article in User Facility Bulletin, 

Summer 2001, Issue Number 35, pages 5-6; M. Pijar & M. Wollerton.

The Impact of MQSA On the General Practice of Radiology: Regulated versus 

Unregulated Environments. Scientific paper and exhibit presented at the 2001 

meeting of the American Association of Physicists in Medicine, Salt Lake City, UT. 

Medical Physics, Vol. 28, No. 6, June 2001 (Abstract); p. 1257. O.H. Suleiman.

Issues Relevant to Medical Physicists Under MQSA’s Final Regulations. 

Presentation at the Medical Technology Management Institute workshops, Feb. 18, 

June 10, and Sept. 30, 2001. Mourad, W.

Medical Device Regulatory Requirements. Presentations at Hood College, 

Frederick, MD.; July 11, 2001; William Sutton

Mammography Equipment Evaluations (MEE) Under MQSA’s Final 

Regulations, poster presentation at the American College of Medical Physicists 

Meeting in Hershey, PA, June 4-6, 2001. Mourad, W.

Medical Physicists Role in Full Field Digital Mammography Facilities. 

Presentation at the American Association of Physicists in Medicine 43rd Annual 

Meeting, July 22-26, 2001, Salt Lake City, UT. Medical Physics, 28, 1243(2001). 

K. Chakrabarti.

MPRIS Overview and Demonstration. Presentation to CRCPD, April 2001. 

Haran, T.,

MQSA Update. Continuing education presentation for radiologic technologists at 

the “A Day of MQSA” meeting in Atlanta, GA, July 31, 2001. M. Divine. 
OHIP FY2001 Annual Report, page 4

Nationwide Evaluation of X-ray Trends: Summary of the 1996 Fluoroscopy 

Survey. Submitted to CRCPD for publication. Richard Kaczmarek.

The Nationwide Evaluation of X-ray Trends: Twenty-five Years of NEXT.

Scientific exhibit presented at the 2001 FDA Science Forum: Science Across the 

Boundaries, (abstract no. 249, February 15-16, 2001, Washington DC.

http://vm.cfsan.fda.gov/~frf/forum01/A249S02.htm). D. Spelic, R. Kaczmarek, 

O. Suleiman, S. Stern.

Navigating the CDRH Website. Presentation at the Medical Alley: Managing 

your Submissions and Web Presence Workshop; Minneapolis, MN.; December 13, 

2000; Frederick B. Winston

Navigating the CDRH Website. Presentation (booth) at the Medical Design and 

Manufacturing (MD&M) West 2000 Conference; Anaheim, CA.; January 8-10, 

2001; Frederick B. Winston; Carol Fedorchak

Navigating the CDRH Website. Presentation (booth) at the Medical Design and 

Manufacturing (MD&M) East Conference; New York, New York, June 5-7, 2001; 

William Sutton, Carol Fedorchak

NEXT 2000 Protocol for Survey of Computed Tomography (CT). December 18, 

2000. (CRCPD publication available at http://www.crcpd.org/intro1.htm, posted 

August 3, 2001). S.H. Stern, D.C. Spelic, R.V. Kaczmarek.

Optimization of Viewing Conditions and Phantom Image Quality Evaluations on 

GE DMR and Full Field Digital Mammography (FFDM) System. J. Digital

Imaging, 13, 226(2000). K. Chakrabarti, J. A. Thomas, R. V. Kaczmarek, 

R.W.Waynant and M. F. Loscocco.

Overview of Medical Device Regulations. 8 Presentations for the Canadian 

Manufacturers; November 14, 2000; Montreal, Canada; Frederick B. Winston, 

William Sutton

Overview of Medical Device Regulations. 8 Presentations for the Canadian 

Manufacturers; November 16, 2000; Halifax, Canada; Frederick B. Winston, 

William Sutton

Overview of the Division of Small Manufacturers, International and Consumer 

Assistance (DSMICA); Global Harmonization; Mutual Recognition Agreement. 

Presentations for San Diego Graduate Students; Rockville, MD.; August 27, 2001; 

Christine Nelson
OHIP FY2001 Annual Report, page 5

Overview of Medical Device Regulations; CDRH Electronic Communications 

Systems. 8 Presentations for the Canadian Government; Ottawa, Canada; May 31, 

2001; Ron Parr, Christine Nelson

Overview of Medical Device Regulations; Global Harmonization; Mutual 

Recognition and Overview of Radiological Health. Presentations for Embassy 

Seminar (Representatives for Medical Device Industry); Rockville, MD.; October 

2000; William Sutton; Christine Nelson, Walter Snesko

Overview of Medical Device Regulations and Quality Systems Presentations at 

Hood College, Frederick, MD.; July 9, 2001; Frederick B. Winston

Overview of Quality Systems. 17 Presentations for the Government of Singapore; 

November 2-3, 2000; Singapore; Judy Strojny

Overview of Quality Systems Requirements for Process Validation.. Presentation 

at the Association for the Advancement of Medical Instrumentation (AAMI) 

Process Validation Workshop; Dallas, TX; December 13-15, 2000; Christine 

Nelson

Overview of Quality Systems Regulations. Presentation at the Association for the 

Advancement of Medical Instrumentation (AAMI) GMP/QS Requirements and 

Industry Practice Workshop; Sanibel Island, Fl.; October 16-19, 2000; Christine 

Nelson

Overview of Quality Systems. Presentation at the Association for the 

Advancement of Medical Instrumentation (AAMI); Frankfurt, Germany; April 23-

27, 2001; Christine Nelson

Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. 

Presentation at the Medical Design and Manufacturing (MD&M) East 

Conference; New York, New York, June 6, 2001; William Sutton

Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. 

Presentation at the Mass MEDIC Exporting Medical Devices to Europe; New 

Frontiers and Opportunities Workshop; Boston, MA; June 7, 2001; Christine 

Nelson

Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. 

Presentation at the Regulatory Professional Society (RAPS) and the Department of 

Commerce Workshop; San Francisco, CA; June 12, 2001; William Sutton
OHIP FY2001 Annual Report, page 6

Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. 

Presentation at the Medical Alley: Exporting Medical Devices to Europe; 

Minneapolis MN.; June 14, 2001; Christine Nelson

Overview of Quality Systems. Presentation at the American Society for Quality 

(ASQ) Workshop; St. Paul, MN.; July 16-17, 2001; Christine Nelson

Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex and 

Where do IVD’s Fit In. Presentation at the FDA/IVD Roundtable, Rockville, 

MD.; July 24, 2001; Christine Nelson

Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex and 

Where Do IVD’s Fit In. Presentation at the AdvaMed Conference; Washington, 

D.C., August 23, 2001; Christine Nelson

Overview of the U.S./EC Mutual Recognition Agreement; Presentation at the 

Japan Association for the Advancement of Medical Equipment (JAMME) 

International Seminar; August 27-31, 2001; John Stigi

Preference Studies of Workstation Monitor Performance. Proceedings of the 5

th

International Workshop on Digital Mammography, June 11-14, 2000, p 612-616, 

Medical Physics (2001). M.F. Loscocco, J.A. Thomas, K.Chakrabarti, and R.V. 

Kaczmarek.

Radiation Dosimetry in X-Ray Computed Tomography (CT): Standardization 

and Regulation. Presentation at 28th Meeting of the Technical Electronic Product 

Radiation Safety Standards Committee, Advisory Committee to the Food and Drug 

Administration, Rockville, Maryland, May 17, 2001, (transcript pages 68-110, 

http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3751t1_01.pdf and 

http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3751t1_02.pdf). Stanley H. 

Stern.

Reports of Corrections and Removals. CDRH User Facility Reporting Bulletin, 

Issue 34, Spring 2001; Frederick B. Winston

Tabulation and Graphical Summary of 1998 NEXT Survey of Pediatric Chest 

Radiography. Submitted to CRCPD for publication. Albert Moyal.

Twenty-seven Years of the Nationwide Evaluation of X-Ray Trends. Scientific 

paper presented at the 2001 meeting of the American Association of Physicists in 

Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 2001, 

(Abstract), p. 1257. D. Spelic, O. Suleiman, R. Kaczmarek, S. Stern, A. Moyal.
OHIP FY2001 Annual Report, page 7

Update of FDA Part 11 Activities. Presentation at the AdvaMed; Electronic 

Records and Electronic Signatures; Boulder, CO; March 1-2. 2001; Christine 

Nelson

Update of U.S./EC Mutual Recognition Agreement. Presentation at the American 

Council of Independent Laboratories; February 26, 2001; Alexandria, VA; 

Christine Nelson

U.S. Regulatory Requirements and U.S./EC Mutual Recognition Agreement. 

Presentation for Government of China; April 16-21, 2001; China; John Stigi

U.S. Regulatory Requirements. 24 Presentations for the Department of 

Commerce and State Drug Administration; Kunming, China; September 10 -12, 

2001; Christine Nelson; Judy Strojny.

The Vessel Dilator for Central Venous Catheter Placement: Forerunner for 

Success or Vascular Misadventure? Journal of Intensive Care Medicine, Volume 

16 – No.6 November/December 2001, pages 263-269; W. Scott, P. Collier. 
OHIP FY2001 Annual Report, page 63

* No longer with OHIP as of 3/ 31/02

OHIP Staffing and Organization

OHIP includes the Office of the Director, two Staffs and four 

Divisions.

Office of the Director

• provides overall leadership and direction

• provides administrative and ADP support to all OHIP programs

Regulations Staff

• develops and advises on the preparation of Federal Register documents, 

including proposed and final regulations and notices

• coordinates the preparation, review and processing of responses to citizen 

petitions

Staff College

• develops and delivers training programs, courses, seminars and lectures

• provides satellite telecasts and distance learning programs on a variety of 

topics

Barr, Wes Garris, Cynthia I. Sullenger, Deborah C.

Brophy, Linda S.* Howell, Heather D. Paras, Peter

Brown, Karen M. Jans, Ronald G. * Vitale, Kimberly J.

Dennis, Malcolm M. Joseph, Lireka P.

Evans, Clifford D. Marshall, J. Lowell

Cassis, Domini H. Hanna, Myrna A. Olson, Jean *

Fischer, Ruth A. Knight, Jacqueline E. Sheehan, Joseph M.

Gilmore, Rosa M. Noland, Bernice E. Wade, Jennette

Brier, Marjory F. Kramer, Mark D.* Nakon, Kimberly K.

Gerhold, Susan H. Morch, Cecile, A. Sauer, Patrice A.

Hanna, Mary R. Nesseler, Steven E. Stewart, Laura L.
OHIP FY2001 Annual Report, page 64

* No longer with OHIP as of 3/ 31/02

Division of Communication Media

• produces videotapes and teleconferences – from script development to 

completed program – using in-house resources

• delivers satellite productions to CDRH, FDA, and national audiences to 

promote the mission and messages of CDRH and FDA

Division of Mammography Quality and Radiation Programs

• implements the Mammography Quality Standards Act, including the 

certification and annual inspection of all mammography facilities

• supports collaborative activities that help protect the public from unnecessary 

exposure to electronic product radiation

• administers the CDRH radiation safety office

Bailey, David W. Jefferson, Arnette L. Rose, Stanley C.

Boyce, Wallace C. Kogok, Richard A.* Scimonelli, Glenn M.

Butler, Bruce E. McCleary, Robert F. Silverman, Laurie

Fatula, Robert H. Monica, Stefan F. Vinson, Jeanine M.

Frederic, Kenton P. Richards, Barbara A.

Abernethy, Scott D. Divine, Michael P. Ratskoff, Ellyce F.

Akey, Catherine L. Finder, Charles A. Robinson, Denise J.

Ali, Fiad M. Flanagan, Margaret Shandruk, Petro

Appleby, Suzanne E. Franke, Kathleen A. Sheridan, Kathleen M.

Ashby, Kimberly A. Friend, Wesley A. Spelic, David C.

Barr, Helen J. Gunzburg, Charles R. Stern, Stanley H.

Belella, Stephanie L. Haran, Timothy J. Suleiman, Orhan H.

Bennaugh, Nancy T. Hoage, Patricia A. Thompson, Donald L.

Boyce, Penny R. Jernigan, Vickie H. Trammell, Dennis L.

Burkhart, Roger L. Kaczmarek, Richard V. Wandell, Evelyn P.

Chakrabarti, Kishalaya McCrohan, John L. Wei, Stella D.

Chesemore, Kaye F. Mourad, Walid G. Wynne, Nancy M.

Chissler, Pamela G. Moyal, Albert E.

Choy, Joanne K. Pack, Randy F.
OHIP FY2001 Annual Report, page 65

* No longer with OHIP as of 3/ 31/02

Division of Device User Programs and Systems Analysis

• provides human factors and systems analysis to reduce use error by 

evaluating device design, instructions for use, and patient labeling in 

premarket and postmarket reviews

• conducts and advises on qualitative research to help construct risk messages 

and analyze internal processes

• develops information and outreach for health professionals and consumers

Division of Small Manufacturers, International and Consumer

Assistance

• educates industry and helps them comply with FDA regulations

• educates consumers on medical device and radiation emitting product issues 

and problems

• educates foreign governments on the U.S. regulatory process

• supports global harmonization and MRA (Mutual Recognition Agreement) 

activities

Appel, Sherrie McCracken, Jack E. Scott, Walter L.

Cangelosi, Robert J. Meadown, Susan K. Seligson, Edith D.

Carstensen, Peter B. Mendelson, Laurel S. Silberberg, Paula G.

Clayton, Carol M. Mendelson, Michael Thomas, Alvin W.

Houchins, Donna E.* Pijar, Mary Lou Tolbert, Margaret T.

Lowe, Nancy S. Rachlin, Jay A. Weiss, Ruth

Kaye, Ronald D. Rooks, Cornelia B. Wollerton, Mary Ann

Kingsley, Patricia A.* Sawyer, C. Richard

Alderton, Bonnie J. Lucas, James E. Stigi, John F.

Alford, Shirley * Nelson, Marie C. Strojny, Judith L.

Allen, Gene E. Park, James J. Sutton, William M.

Auerbach, Jessica B. Parr, Ronald P. Taylor, Tawana V.

Barcome, Althea L. Pritchard, Lisa M. Watts, Crystal

Bracey, Alfred Puleo, Joseph V. Weller, Phyllis S.

Cardamone Thomas E. Raines, Joyce A. Weiner, Deborah C. * 

Clark, Geoffrey S. Rice, Lynne L. Willis, Marcellus E. *

Fedorchak, Carol M. Rodgers, Anthony E. Winston, Frederick B. *

Freeman, Nancy J.* Snesko, Walter M. Yellin, Arthur K.

Greberman, Melvyn* Stellar, Barbara P.

Leonard, Nancy M.
OHIP FY2001 Annual Report, page 66

OHIP Organization Chart