Office of Health and Industry Programs 

Center for Devices and Radiological Health 

Food and Drug Administration 

Department of Health and Human Services 

2003 Annual Report 
(this page intentionally left blank)
 

Introduction 

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), Food and Drug Administration (FDA), we 

specialize in program-based communication, education, radiological 

health, mammography quality, and reduction of use error. 

FY 2003 was noteworthy for OHIP in many program areas. These 

noteworthy accomplishments are discussed in detail throughout this 

report. Overall, OHIP’s 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 FY 2003, OHIP worked toward the 

CDRH mission, vision and strategic goals – 

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

Throughout this report, you will see that outreach and education are in 

all aspects of our 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, we serve a wide variety 

of customers. Our customers include: 

• 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 this 

report. We welcome your review and your comments on our efforts and 

our future directions. 

Dedication: The FY 2003 OHIP Annual Report is dedicated to ALL past 

and present staff who have been instrumental in allowing us to achieve our 

public health goals. We are especially grateful for the contributions and 

leadership of Dr. Lireka P. Joseph, Assistant Surgeon General, U.S. 

Public Health Service. Dr. Joseph, the Director of OHIP during FY 2003, 

passed away in February of 2004. 
OHIP FY 2003 Annual Report, page 1 

 

TABLE OF CONTENTS

User Education .....................................................3

Consumer Assistance.................................................................................... 3

Consumer Webpage....................................................................................... 4

Consumer Inquiries........................................................................................ 4

Breast Implant Information............................................................................ 5

New Device Approvals ................................................................................... 5

Diabetes Webpage.......................................................................................... 6

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

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

Secondary School Project – FDA & You ...................................................... 8

Whole Body CT Screening Webpage............................................................ 9

OIVD Website................................................................................................ 10

Human Factors Website Redesign.............................................................. 10

North American Precis Syndicate (NAPS) Article...................................... 10

Contacts Listing Database .......................................................................... 11

Constituent Relations Meeting with JCAHO and ACC .............................. 12

Center-wide Communication Plan .............................................................. 12

Manufacturer Support ........................................13

Small Business Activities ............................................................................ 14

Assisting Manufacturers.............................................................................. 15

Device Advice Webpage ............................................................................ 17

Workshops/Presentations .......................................................................... 18

Developing Guidance for Manufacturers.................................................... 19

International Activities.......................................20

Foreign Manufacturers of Medical Devices................................................ 20

Regulatory Training and Assistance........................................................... 21

International Conferences .......................................................................... 22

Global Harmonization .................................................................................. 23

U.S./European Mutual Recognition Agreement ........................................ 23

Radiological Health Programs............................25

Mammography Quality................................................................................. 25

MQSA Webpage ........................................................................................ 26

Assuring Quality Mammography ................................................................ 27

Improving the MQSA Program ................................................................... 28

NMQAAC ................................................................................................... 31

NEXT.............................................................................................................. 32

NEXT – 1973 to 2003................................................................................. 32

Annual Surveys.......................................................................................... 33
OHIP FY 2003 Annual Report, page 2 

 

NEXT Survey Results ................................................................................ 34

TEPRSSC .......................................................................................................35

Dental X-Ray Examinations..........................................................................35

Radiation Safety ............................................................................................36

Reducing Use Error ............................................38

Human Factors ..............................................................................................38

Labeling .........................................................................................................40

Electronic Labeling..................................................................................... 40

Use Error Model ............................................................................................41

Regulations and Guidance .................................42

Regulations....................................................................................................42

Good Guidance Practices.............................................................................43

Plain Language..............................................................................................44

MDUFMA .............................................................44

OHIP Responsibilities...................................................................................44

CDRH Staff College ............................................50

Training Highlights........................................................................................50

Academic Partnerships.............................................................................. 51

Course Highlights....................................................................................... 52

Teleconference/Video Production .....................55

Counter Terrorism Activities............................. 59 

Emergency Response...................................................................................59

Communication Plan.....................................................................................59

Bioterrorism Teleconferences .....................................................................59

Appendix.............................................................60

OHIP Staffing and Organization...................................................................60

Office of the Director.................................................................................. 60

Regulations Staff........................................................................................ 60

Staff College .............................................................................................. 60

Division of Communication Media.............................................................. 61

Division of Mammography Quality and Radiation Programs...................... 61

Division of Device User Programs and Systems Analysis ......................... 62

Division of Small Manufacturers, International and Consumer Assistance 62

OHIP Organization Chart ..............................................................................63
OHIP FY 2003 Annual Report, page 3 

 

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 or 

electronic media. 

Consumer Assistance

OHIP is responsible for providing consumers with information needed 

to make informed decisions on the use of medical devices and 

radiation-emitting electronic products. We accomplish this by 

answering consumer inquiries and by developing information that 

addresses specific, high interest issues. For example, our staff served 

as the contact point within CDRH for inquiries related to an article in 

the AARP Newsletter that dealt with full body CT scans. 

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 FY 2003 Annual Report, page 4 

 

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 sites; and 

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

Consumer Inquiries

During FY 2003, our consumer specialists responded to 

approximately: 

• 3,735 telephone inquiries; 

• 3,000 e-mails; 

• 300 letters and faxes; and 

• 6,000 requests for information packages on various medical 

device issues. 

3

http://

www.fda.gov/

cdrh/consumer/
OHIP FY 2003 Annual Report, page 5 

 

Breast Implant Information 

OHIP has two representatives on CDRH’s Breast 

Implant Committee. The Committee meets once 

monthly to review and discuss PMA submissions, preand post-market compliance problems, interactions with 

the plastic and aesthetic surgery organizations, new 

articles in the scientific and medical journals, and 

problems reported by consumers and their advocacy 

groups. The Committee has also established a website 

and updated a handbook entitled “Breast Implants: An 

Information Update” and “Breast Implant Risks”, a 

brochure for consumers. 

The OHIP representatives established a Listserv dedicated to 

consumers. By subscribing, consumers receive periodic electronic 

information on breast implants such as new articles in the literature, 

public meetings, recalls, safety alerts, citizen petitions, and adverse 

events. 

OHIP has also designated a staff person who is specifically dedicated 

to answering consumer inquiries on breast implants. This enhances 

the quality and consistency of our responses and the information we 

provide. 

New Device Approvals

As part of our effort to better inform the public about new 

device technology, CDRH posts short news items when 

devices with significant new advances are approved or 

cleared. Posted to a webpage titled "Recently Approved 

Devices," these short summaries are plainly written and 

intended primarily for consumers. OHIP provides the 

plain language review of these "one-pagers" and identifies 

links to other sources of unbiased, well researched 

consumer information. In FY 2003 OHIP reviewed over 

30 one-page summaries. 

3

http://

www.fda.gov/

cdrh/consumer

/mda/

3

http://

www.fda.gov/

cdrh/

breastimplants/
OHIP FY 2003 Annual Report, page 6 

 

Diabetes Webpage

Since OHIP posted the Diabetes website in 2002, we have continued 

to learn about designing and developing more usable websites. In the 

spring of 2003, OHIP decided to perform a heuristic evaluation and a 

usability evaluation of the diabetes website. First, we hired an outside 

expert to evaluate the site. Then the expert conducted a usability test 

of the website using participants who had experience living with or 

caring for someone with diabetes. The expert provided a written 

report with comments and suggestions for improving the site. 

The results of the two evaluations provided valuable feedback about 

the structure and content of the website. We learned how to improve 

our writing style to make it more appropriate to web communication, 

how to increase our search engine visibility, and how to structure the 

website to optimize user satisfaction. In addition, we learned new 

techniques for conducting our own usability evaluations throughout 

the website development process. 

Using the recommendations from the expert evaluators, OHIP 

redesigned the Diabetes website 

Hospital Bed Safety

OHIP continued to lead the multidisciplinary group known as the 

Hospital Bed Safety Workgroup (HBSW). The Workgroup’s goal is 

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 HBSW continues to educate caregivers and family members 

about the problems associated with bed rail use. The group developed 

a document entitled “Clinical Guidelines for the Assessment and 

Implementation of Bed Rails in Hospitals, Long Term Care Facilities 

and Home Care Settings.” These guidelines assist caregivers in 

assessing when hospital patients or nursing home residents are at risk 

of entrapment in their beds and provide guidance for change. 

3

http://

www.fda.gov/

diabetes/
OHIP FY 2003 Annual Report, page 7 

 

Bedrail safety information and a hyperlink to the clinical 

guidelines document are available on the FDA website. 

Additionally, CDRH worked with AARP to complete an 

educational videotape on hospital bed safety for 

caregivers and patient families. The video provides the 

viewer with real-life situations in both acute care and 

long-term care environments and offers insights by 

patients, their families, physicians, nurses and other caregivers about 

hospital bed environments. 

Lastly, OHIP is working on a guidance document that will provide 

dimensional limits to prevent entrapment in new hospital beds. Health 

care facilities may also use this guidance to determine if their existing 

beds present a risk for patient entrapment. 

The issue of entrapment is a complex one and CDRH, along with its 

partners, is working towards a long-term resolution of this safety 

concern. 

User Facility Reporting Bulletin

Eleven years ago, we published the first issue of the User 

Facility Reporting Bulletin (UFRB) to assist hospitals, 

nursing homes, and other medical device user facilities in 

complying with the Medical Device Reporting (MDR) 

requirements of the Safe Medical Devices Act of 1990 

(SMDA). SMDA imposed significant reporting 

requirements on facilities that use medical devices. 

Device user facilities such as hospitals, outpatient 

diagnostic and treatment facilities, and nursing homes 

were required to report device-related deaths, serious 

injuries and serious illnesses within ten days of the 

adverse event to the manufacturer, the FDA, or both. 

This was the first time these facilities were required to 

report to the FDA and manufacturers. 

SMDA charged CDRH to inform user facilities how and when to 

comply with the various sections of SMDA. In 1991, CDRH held 

http://

3

www.fda.gov/

cdrh/

fusenews.html

3

http://

www.fda.gov/

cdrh/beds/
OHIP FY 2003 Annual Report, page 8 

 

seven conferences on MDR and asked the conference participants 

what would help them comply with the new law. Most participants 

said they could better comply with SMDA if they received feedback 

on reports received by CDRH. In response to the suggestions from 

participants, we began publishing the User Facility Reporting Bulletin 

in the spring of 1992. Our commitment was to report on the safety of 

medical devices. We further committed the UFRB to provide 

information about problems encountered in mandatory reporting and 

suggestions for deciding what to report. 

A few years ago, we began to evaluate the need to continue publishing 

the UFRB. We reduced our mailing list to hospitals and other user 

facilities from 70,000 printed copies to 10,000 and later decided to 

continue to publish online only. After affirming that we had provided 

the necessary training and education for the user facilities to comply 

with the SMDA, MDR, and the Medical Device Amendments of 

1992, we began to focus more of our attention to providing feedback 

on adverse events as they were occurring. In the past few years, we 

also began publishing information that was not directly related to user 

facility reporting but had a directly beneficial effect on hospitals. 

After long and careful consideration, we decided that the UFRB had 

served its purpose, and the time had come to discontinue publishing. 

In 2003, after 11 years, we ended our publication with the 

Spring/Summer Issue, # 42. All of the issues are still available on our 

website. 

Secondary School Project – FDA & You

FDA & You is an educational newsletter intended for use by 

health educators, secondary school students and their parents. A 

cooperative effort, FDA & You combines the skills and support 

of FDA’s five Centers. It encourages health educators and 

students to learn about the latest FDA medical product and health 

news. To coincide with the typical school year, FDA & YOU is 

published three times per year, in the fall, winter and spring. 

3

http://

www.fda.gov/

cdrh/

fdaandyou/
OHIP FY 2003 Annual Report, page 9 

 

The first issue of FDA & YOU was mailed to 16,000 health educators 

and principals throughout the U.S. and the newsletter is now available 

on the CDRH website. 

OHIP is in the process of promoting and expanding outreach of the 

secondary school newsletter program. Current plans of promotion 

include: 

• building an increased awareness throughout other 

government agencies with similar initiatives (i.e. 

Department of Education and NIH); 

• expanding the web presence of FDA & YOU; 

• creating additional educational resources for teachers 

available on the webpage; and 

• promoting the newsletter to target populations such as 

secondary school principals at the National Association of 

Secondary School Principals (NASSP) annual conventions. 

Whole Body CT Screening Webpage

During FY 2003, OHIP supplemented its webpage on whole-body 

computed tomography (CT) screening with the publication of a 

consumer brochure and article. Whole body CT screening has not 

been demonstrated to meet generally accepted criteria for an effective 

screening procedure. However, some medical imaging facilities are 

promoting this use of CT and market this screening procedure to 

healthy individuals who have no symptoms or suspicion of disease. 

Moreover, many medical professional societies have discouraged CT 

screening for individuals without symptoms. 

The consumer brochure, Full-Body CT Scans – What 

You Need to Know, points out the lack of proven 

benefits to healthy people from CT screening. The 

OHIP produced consumer article was released through 

the North American Precis Syndicate, Inc. (NAPS) to 

over 10,000 newspapers nationwide. The article 

summarizes the information in the brochure and on the 

CDRH website (see “NAPS Article” on page 10 for 

more details). 

3

http://

www.fda.gov/

cdrh/ct/
OHIP FY 2003 Annual Report, page 10 

 

OIVD Website

OHIP collaborated with CDRH’s Office of In Vitro Diagnostic 

Device Evaluation and Safety (OIVD) to design and implement 

the OIVD website. This website was developed in order to help 

address the specific regulatory, educational, and scientific needs 

of this new Office as it was established in CDRH. The website 

posted in February 2003. 

The OIVD website serves as a model of inter-office 

collaboration. Throughout the development process, OHIP 

worked very closely with OIVD staff to determine the intended 

audiences and the messages that the website would convey. 

OHIP coordinated all aspects of designing the information 

architecture, collecting and assembling documents, and writing 

and editing final text. This collaborative experience helped OHIP 

develop procedures for working with other offices on web 

outreach activities. 

Human Factors Website Redesign

OHIP redesigned the Human Factors website to help visitors find 

information about FDA's Human Factors Program. This website 

consolidates all human factors and use error information into one 

cohesive website. It gives links to key guidance documents and 

publications, and explains the role of human factors in the safe 

use of medical devices. 

NAPS Article

OHIP launches many efforts to increase consumer awareness of 

FDA’s web presence. In May of 2003, OHIP composed a short article 

listing various FDA health websites and also announced the 

ContactsListing Database (see below). 

The article was given to a contractor, the North American Precis 

Syndicate (NAPS) who distributed the piece to newspapers 

throughout the country. Subsequent surveillance of this distribution 

3

http://

www.fda.gov/

cdrh/oivd/

3

http://

www.fda.gov/

cdrh/

humanfactors/
OHIP FY 2003 Annual Report, page 11 

 

was performed by both OHIP and NAPS for the remainder of the 

year. By the end of FY 2003, the article had been published in 276 

newspapers with a possible outreach to 10,517,456 readers. 

Contacts Listing Database

In 2002, CDRH posted a new database with a web 

interface entitled “Contacts Listing.” The database 

collects the names of individuals interested in helping 

CDRH examine issues, develop policy, and inform people 

with specific interests. Contacts Listing expands on the 

idea of a listserv by gathering information about a 

participant that enables CDRH to target its shareholders 

more accurately. It alleviates the need to maintain paper 

lists of contacts. 

Web visitors voluntarily sign up for the database at no cost and choose 

areas of interest from several lists. CDRH staff search the collected 

information by the subscribers areas of interest, their geographic 

region, and their medical specialty or affiliation. This allows CDRH 

to find potential participants for stakeholder activities and policy 

development forums. CDRH can also use Contacts Listing to e-mail 

information on topics of special interest to activity participants. 

Typical uses might be informing individuals in particular geographic 

areas about upcoming teleconference viewing locations; reporting 

recalls and safety issues to risk managers; announcing a new website 

that pertains to a particular interest area like diabetes; and, seeking 

collaboration with other investigators researching a particular issue. 

In 2003, OHIP improved the website to make it faster and easier to 

operate. Visitors to the website can see all the past messages to 

members and sign up to be sent information routinely on selected 

topics. We have advertised Contacts Listing at public forums and 

invited health educators to subscribe when we mailed out 16,000 

copies of the FDA & You newsletter to schools and health educators. 

The total membership of the list approaches 2000 subscribers with 

diverse interests in healthcare. 

http://www.acce

3

ssdata.fda.gov/sc

ripts/cdrh/cfdoc

s/contacts/index.

cfm 
OHIP FY 2003 Annual Report, page 12 

 

Constituent Relations Meeting with JCAHO and ACC

During FY 2003, two meetings were held with external constituents 

under the Constituent Relations Program. The meetings were 

arranged to exchange views on medical device issues, share scientific 

and technical information, and to explore opportunities for 

collaborative work. 

In a meeting with the Joint Commission on Accreditation of Health 

Organizations (JCAHO), we discussed adverse event reporting under 

the MedSun program, patient safety, hospital bed safety and 

electromagnetic interference. 

The meeting with the American College of Cardiology (ACC) was 

prompted by CDRH’s interest in cardiovascular health and related 

medical devices. 

Center-wide Communication Plan

We began the development of a Center-wide communications and 

outreach plan in order to enhance the dissemination of CDRH’s key 

messages to consumers, health professionals, industry, other 

government agencies and healthcare organizations. With the plan, we 

hope to design and implement a comprehensive communications 

concept and operational strategy that will better support the CDRH 

mission. 

Recognizing that CDRH’s external communication activities are 

dependent upon, and driven by, internal communication among 

CDRH staff and managers, we established the Communication 

Liaisons Committee with representatives from each of the Center 

Offices. Meetings are underway to build a structure for increased 

outreach coordination throughout the Center. 
OHIP FY 2003 Annual Report, page 13 

 

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 18,000 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 FY 2003 Annual Report, page 14 

 

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. 

As discussed elsewhere in this report under MDUFMA, OHIP 

successfully met our deadlines under MDUFMA with regards to 

Small Business activities: 

• served as the lead within CDRH for the MDUFMA Small 

Business Determination (SBD), processing 135 SBD requests 

(125 were granted and 10 were denied); 

• prepared a guidance document entitled: Guidance for 

Industry and FDA: FY 2003 MDUFMA Small Business 

Qualification Worksheet and Certification (this guidance 

will be updated each year); and 

• presented a live broadcast on instructions for filling out the 

MDUFMA cover sheet. 

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. 

3

http://

www.fda.gov/

ora/fed_state/

small_business/

sb_guide/

intro.html

3

http://

www.fda.gov/

cdrh/mdufma/
OHIP FY 2003 Annual Report, page 15 

 

The other 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 services are discussed in 

more detail in the following pages. 

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 20,000 e-mail 

inquiries per year. In addition, we receive and respond to 

approximately 2,000 written/fax inquiries per year. 

OHIP/CDRH 

Division of Small 

Manufacturers, 

International and 

Consumer Assistance 

1-800-638-2041 

301-443-6597 

Automated Assistance 

available 24/7 

Device Specialists

available M-F 

8 a.m. to 5 p.m., EST 
OHIP FY 2003 Annual Report, page 16 

 

• 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. 

• 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. 

• Facts on Demand (FOD): FOD is an 

automated answering system that allows 

requestors to access over 700 CDRH 

publications via the facsimile 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 2003, 

approximately 2,500 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% are 

accessible electronically, our stakeholders still request 

hardcopies. In FY 2003, approximately 100,000 

publications were distributed either by hardcopy or on 

diskette. 

CDRH 

Facts on Demand 

800-899-0381 

301-827-0111 

Catalog available on your fax machine 

after dialing the above number and: 

 Press "1" to enter the system and 

obtain documents; or 

 Press "2" to obtain instructions 

for using the system 

 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. 

3

http://

www.fda.gov/

cdrh/dsma/

510_stat.html
OHIP FY 2003 Annual Report, page 17 

 

http://www.fda.

3

gov/cdrh/industr

y/support/

• 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 26,000 

hits in FY 2003. 

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 100,000 hits in FY 2003. With 

Device Advice, you can determine: 

• whether the product you want to market is 

3⁄4 a radiation-emitting electronic product, 

3⁄4 a medical device, 

3⁄4 both a radiation-emitting electronic product and a 

medical device, or 

3⁄4 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. 

3

http://

www.fda.gov/

cdrh/

devadvice/ 
OHIP FY 2003 Annual Report, page 18 

 

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 2003, we modified topics to 

include the following information: 

• new 510(k) Review Fee page; 

• new PMA Review Fee page; 

• new section on PMAs which provides a complete revision of 

the PMA manual with updated information including 

modular reviews; 

• information on CDRH workshops; 

• updates to three pages to include links to the new Office of 

In Vitro Diagnostic Device Evaluation and Safety website; 

and 

• updates to the labeling page which add references to two 

new guidance documents. 

Workshops/Presentations 

During FY 2003, OHIP partnered with other organizations in 

presenting 15 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); 

• Western New York Technology Council; 

• AdvaMed; and 

• Medical Design & Manufacturing (MD&M) 

3

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workshop.html
OHIP FY 2003 Annual Report, page 19 

 

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: 

• Guidance for Industry and FDA: FY 2003 MDUFMA 

Small Business Qualification Worksheet and 

Certification; and, 

• Implementation of the Inspection by Accredited Persons 

Program under MDUFMA. 
OHIP FY 2003 Annual Report, page 20 

 

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 FY 2003, 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. 

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 FY 2003 Annual Report, page 21 

 

OHIP uses the same mechanisms to support foreign manufacturers as 

those used for domestic manufacturers. During FY 2003, our 

assistance to foreign manufacturers included: 

• answering more than 2,000 telephone inquiries; 

• responding to more than 3,000 e-mails and 400 letters and 

faxes; and 

• mailing more than 500 information packages on various 

medical device issues. 

In addition, the International Programs webpage received 12,000 hits 

throughout the year. 

Regulatory Training and Assistance 

OHIP coordinates education for foreign governments and industry 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 FY 2003, OHIP hosted 69 international visitors from 11 

countries. The country and number of visitors are as follows: 

• Canada (2) 

• China (1) 

• Germany (4) 

• Israel (4) 

• Japan (16) [including one 10-month training program with the Ministry of Health and Labour Welfare]

• Korea (6) 

• Pakistan (1) 

• Russia (15) 

• Singapore (16) 

• South Africa (3) 

• Switzerland (1) 
OHIP FY 2003 Annual Report, page 22 

 

International Conferences 

In addition to 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 2003, 

OHIP participated in 13 international industry professional 

conferences. Recent presentations include: 

• Canada – Overview of MDUFMA; Overview of Medical 

Device Regulations; 

• China – U.S. FDA Approach to Auditing; Role of Third 

Party Organizations; 

• Embassy of Ireland – FDA Approach to Auditing; Guidance 

on Part 11, Electronic Records and Electronic Signatures; 

• Germany – U.S. FDA approach to Auditing; Guidance on 

Part 11, Electronic Records and Electronic Signatures; 

Introduction to FDA Requirements & Terminology; 

• Panama – Overview of the Medical Device Regulatory 

Program; Overview of the Global Harmonization Task 

Force; 

• Russia – Overview of Medical Device Regulations; 

Overview of Quality Systems Regulations and Quality 

System Inspection Technique; 

• South Korea – Overview of Quality Systems; Overview of 

Medical Device Regulations; U.S./EC Mutual Recognition 

Agreement; 

• Singapore – Overview of Quality Systems; 

• Switzerland – U.S. FDA Approach to Auditing; and, 

• United States – Overview/update on U.S./EC MRA; CE 

Marking for the EU Medical Device Directives. 
OHIP FY 2003 Annual Report, page 23 

 

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 worldwide 

medical device regulation to facilitate international trade, to promote 

technological innovation, and to enhance public health. 

During FY 2003, OHIP: 

• participated in monthly CDRH meetings to update the 

Center Director and coordinate activities; 

• attended meetings of Study Group 4 on Regulatory Auditing 

of Quality Systems in Rockville, Maryland and Bern, 

Switzerland; and 

• attended a meeting of Study Group 2 on Postmarket 

Vigilance in Lubeck, Germany. 

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 

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OHIP FY 2003 Annual Report, page 24 

 

“product sectors” that include telecommunication equipment, 

electromagnetic compatibility (EMC), pharmaceutical good 

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

and medical devices. 

The Medical Device Annex of the U.S./EC MRA provides for three 

types of regulatory activities: (1) the exchange of quality systems 

inspection/audit reports; (2) product evaluation reviews and/or testing 

for select low to medium-risk devices; and (3) establishing a program 

for exchanging information on serious health risks posed by medical 

devices. 

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

the MRA. In FY 2003, our accomplishments include: 

• completed the Fourth Annual MRA report; 

• confirmed that seven EU CABs meet the FDA criteria; 

• provided classroom training in the FDA device regulations 

and inspection procedures and policies to EU CAB auditors; 

• authorized four EU CABs to conduct independent 

inspections of EU device manufacturers on behalf of FDA; 

• evaluated U.S. CAB dossiers and confirmed that seven U.S. 

CABs meet EU criteria; 

• forwarded summaries of the dossier evaluations to the EC; 

and 

• observed and evaluated one U.S. CAB auditing a U.S. 

manufacturer against EU device requirements. 

Future work includes observing and evaluating the other U.S. CABs 

as they audit manufacturers; conducting on-site audits of U.S. CABs 

at their business sites; and continuing to train, evaluate and qualify EU 

CABs to conduct independent audits. 
OHIP FY 2003 Annual Report, page 25 

 

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. CDRH’s Radiological Health Council 

has continued efforts to revitalize our radiological health programs. 

The Council pursues 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

On October 31, 2002, OHIP celebrated the 10th Anniversary of the 

Mammography Quality Standards Act of 1992 (MQSA). OHIP 

implements the MQSA, which Congress enacted in order to ensure 

that all women have access to quality mammography for the detection 

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 FY 2003 Annual Report, page 26 

 

of breast cancer in its earliest, most treatable stages. 

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 

Detailed information on all aspects of the MQSA program can be 

found at the Mammography Program website. Examples of 

documents currently available on the webpage include: 

• an overview of FDA’s Mammography Program; 

• the Mammography Quality Standards Act; 

• Federal Register Notices; 

• a listing of certified mammography facilities, searchable 

by zipcode; 

• Mammography Facility Performance Reports; 

• MQSA Program Accomplishments; 

• consumer-specific information; and

• the MQSA Policy Guidance Help System. 

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 FY 2003 Annual Report, page 27 

 

The MQSA Policy Guidance Help System (PGHS) is an information 

resource that is structured like a Windows help system. It is organized 

by main topics, or books. Each book includes a list of subtopics, or 

pages, that contain guidance. Many of the pages begin with the 

regulatory citation related to the selected topic, followed by questions 

and answers offering guidance on how to 

comply with the regulations. 

The PGHS allows mammography facilities 

and other interested parties to search for 

answers to specific 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 see the regulatory citation, any relevant 

guidance documents, and any other 

appropriate information and references. 

Assuring Quality Mammography 

Approximately 9,100 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 FY 2003, the five 

accreditation bodies and the number of facilities they accredit were: 

• American College of Radiology (8,288) 

• State of Arkansas (71) 

• State of California (466) 

• State of Iowa (141) 

• State of Texas (150) 

To assure mammographic quality, mammography facilities undergo 

annual inspections by FDA trained inspectors1

. Approximately 9,000 

 

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. 

Toll Free Mammography 

Information Service 

1-800-4-CANCER 

1-800-422-6237 

CDRH works with the National 

Cancer Institute to provide: 

 information about FDA-certified 

mammography facilities; 

 answers to questions; and, 

 referrals to free or low cost 

mammography facilities. 
OHIP FY 2003 Annual Report, page 28 

 

Figure 1. Preliminary FY 2003 Inspection Results

Level 2

23%

Level 3

9%

No Finding

65.5%

Level 1

2.5%

• 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.

inspections take place each year. Nearly two-thirds of the facilities 

(65.5%) had no adverse observations during their inspections this 

fiscal year. About 9% of facilities had nothing worse than minor 

(Level 3) observations, while 23% had moderate (Level 2) 

observations as their most 

significant result. Finally, about 

2% had serious (Level 1) 

observations during their 

inspection. 

The percentage of facilities with 

significant inspection 

observations continues to 

decrease compared with 

previous years and CDRH is 

confident that mammography 

facilities will continue to 

improve their performance. 

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 FY 2003 are listed below. 

• Digital Mammography: This 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. To date, CDRH’s Office of Device Evaluation 

(ODE) has approved the following Full Field Digital 

Mammography (FFDM) systems for commercial use: the 

General Electric (GE) Senographe 2000D, January 2000; the 

Fischer SenoScan, September 2001; the Lorad Digital Breast 

Imager, March 2002; and the Lorad Holgic Selenia FFDM 

System, October 2002. 
OHIP FY 2003 Annual Report, page 29 

 

Currently, there are 413 FFDM units accredited in the U.S. Also, 

in FY 2003, FDA approved the following Accreditation Bodies to 

accredit FFDM units as follows: 

3⁄4 American College of Radiology 

- GE Senographe 2000D (approved 12/18/02; became 

effective 02/15/03) 

- Fischer SenoScan (approved 07/24/03; became effective 

08/15/03) 

- Lorad Selenia (approved 09/05/03; became effective 

09/15/03) 

3⁄4 State of Iowa 

- GE Senographe 2000D (approval date 08/28/03; effective 

10/01/03) 

- Lorad Selenia (approval date 08/28/03; effective 10/01/03) 

• States as Certification Agencies (“States as Certifiers” or 

SACs): This project successfully transferred certain key MQSA 

responsibilities to the states of Illinois and Iowa under a 

demonstration program during the summer of 1998. The program 

authorizes qualified states to certify mammography facilities 

within their jurisdiction, to conduct annual inspections, and to 

enforce the MQSA quality standards under FDA oversight. In the 

first half of 2004, FDA expects to transition these SACs from the 

demonstration program under the interim regulations to the final 

regulations, which were published by the Department of Health 

and Human Services on January 18, 2002. 

• Inspection Demonstration Program: Under the MQSA 

Reauthorization Act, Congress authorized the Food and Drug 

Administration (FDA) to undertake an inspection demonstration 

program (IDP) to assess the results of conducting some 

mammography inspections less frequently than annually. The 

purpose of the program is to evaluate whether selected 

mammography facilities can maintain the same level of quality 

without FDA's current scrutiny through its annual inspections. In 

its final form, the IDP includes approximately 160 study group 

facilities and an equal number of controls in 14 States or other 

governmental jurisdictions that have agreed not to inspect these 
OHIP FY 2003 Annual Report, page 30 

 

facilities under their own authority during the study period. The 

first half of these facilities were selected and notified in November 

2001 and the second half were selected and notified in May 2002. 

Each facility was randomly selected from a set of eligible facilities 

on a jurisdiction-by-jurisdiction basis. The facilities must have had 

a clean inspection history for the last two inspections to be eligible. 

The facilities in the study group are undergoing biennial 

inspections during the demonstration program and the inspection 

process will look at the same areas as the current annual 

inspections but records will be reviewed for the entire period since 

the last inspection date. Approximately one half of these facilities 

have now received their delayed inspection. All study group 

facilities should be inspected by the end of August 2004 and 

results should be available by early FY 2005. 

• MQSA Compliance Activity: FDA is preparing to implement a 

new enforcement strategy effective October 1, 2003. Under the 

new strategy, facilities with the most significant observations will 

be directed to respond in writing within 15 days of the inspection, 

rather than almost always being sent a Warning Letter. That 

response will be reviewed by the FDA prior to taking any further 

action. If there is no response or if the response is inadequate, then 

a Warning Letter could be issued. If the response appears adequate 

but the facility has a history of violations, then a fee-based followup inspection could be scheduled. In addition, Warning Letters 

may be followed by a non-fee-based follow-up inspection within a 

few months to assure that correction has been made. 

This new strategy will focus more attention on facilities with a 

history of violations. CDRH also is looking at whether changes 

may be needed on how repeated inspection violations are defined. 

In parallel with the new enforcement strategy, CDRH will increase 

the rate of enforcement actions to direct appropriate attention to 

those facilities that exhibit significant problems that they can not or 

will not correct. During FY 2003, CDRH issued 2 directed plans of 

correction (DPC), 1 civil money penalty (CMP), and 1 patient 

notification. 
OHIP FY 2003 Annual Report, page 31 

 

• Additional Mammography Review Process (AMR): CDRH is 

also beginning a review of AMR process and procedures. An 

AMR is a review of clinical images and other relevant information 

to assure that the facility is in compliance with MQSA. CDRH has 

had preliminary discussions about AMRs internally and with 

approved accreditation bodies. It is examining a number of issues 

specific to AMRs and Patient and Physician Notifications (PPNs) 

that include: 

3⁄4 reasons for requesting AMRs; 

3⁄4 procedures for performing AMRs (number of cases and number 

of reviewers); 

3⁄4 criteria used to evaluate AMRs; 

3⁄4 methods for evaluating the effectiveness of Corrective Action 

Plans and/or PPNs; and. 

3⁄4 role of medical outcomes and other evidence in the AMR/PPN 

process. 

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. 

The Committee met on April 28, 2003 and reviewed and 

suggested revisions to two MQSA guidance documents. 

The Committee also discussed how MQSA 

reauthorization might impact current regulations and 

possible ways to streamline the regulations and facility 

inspection procedures. 

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OHIP FY 2003 Annual Report, page 32 

 

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. 

NEXT – 1973 to 2003 

The NEXT program represents a thirty year partnership between 

FDA and the States. 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. Since 1998, NEXT training for State 

surveyors has been partially supported by the American College of 

Radiology through funding to the CRCPD. 

Hands-on training for NEXT x-ray surveyors at the 

National Naval Medical Center in Bethesda, Maryland

Goals 

1. Develop standard survey protocols for a variety of x-ray examinations and 

train State radiation control personnel to conduct the surveys. 

2. Determine population statistics for radiation dose and image quality from 

representative clinical x-ray examinations in the U.S. 

3. Monitor trends in the practice of diagnostic x-ray as equipment and 

applications evolve. 

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OHIP FY 2003 Annual Report, page 33 

 

Recent NEXT Surveys 

Survey 

Year 

Type(s) of X-ray 

Examination Status 

1998 Pediatric chest 

radiography 

Survey analysis completed and 

statistical summary submitted 

to CRCPD for publication. 

1999 Intraoral 

cephalometric, and 

panoramic dental 

radiography 

Survey analysis completed and 

statistical summary submitted 

to CRCPD for publication. 

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 included 

procedures for new digital 

imaging systems. Data analysis 

in progress. 

2002 Adult Abdomen and 

Lumbosacral Spine 

Repeat of survey conducted in 

1995. Surveyors were 

equipped with laptop software 

that performed all calculations 

previously done by hand. Data 

analysis in progress. 

2003 Fluoroscopy Survey near end of data 

collection phase. 

*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. 

Annual Surveys 

Under NEXT, the surveys for a given year are directed at a single xray procedure and are conducted in a national cross section of clinical 

facilities. 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 this page shows the status 

of the 1998 through 2003 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. 

Selecting different xray examination from 

year to year provides 

data on a variety of 

radiographic 

procedures while 

minimizing the 

workload during any 

one year. By 

periodically repeating 

NEXT surveys for a 

particular x-ray 

examination, the data 

can be used to identify 

trends or changes over 

the course of time. 
OHIP FY 2003 Annual Report, page 34 

 

NEXT Survey Results 

OHIP prepares a comprehensive report summarizing statistical results 

for each survey. 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 and 

medical journals. 

During FY 2002-2003, OHIP gave presentations related to NEXT at 

several professional meetings including the FDA Science Forum, the 

annual meeting of the Conference of Radiation Control Program 

Directors, and the annual meeting of the American Association of 

Physicists in Medicine (AAPM). 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 safety concerns about patient 

exposure. 

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

seven diagnostic examinations. The NEXT surveys: 

• provide a standard of practice against which clinical 

facilities can compare their patient exposure levels in order 

to maintain a safe and beneficial practice; 

• have been used as a standard for comparison during 

inspections by the Joint Commission on Healthcare 

Organizations (JCAHO); 

• are currently being referenced by the American Association 

of Physicists in Medicine (AAPM) and the ACR in efforts 

to develop patient exposure reference values for standards of 

clinical practice; and 

• are gaining international attention from such agencies as the 

IAEA (International Atomic Energy Agency) as a model 

program for collecting population exposure data from 

diagnostic x-ray exams. 

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OHIP FY 2003 Annual Report, page 35 

 

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 many electronic products. 

Examples of these products include lasers, sunlamps, microwave 

ovens, ultrasound medical equipment, cabinet x-ray systems and 

diagnostic x-ray systems. In addition to the 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. 

During the October 1, 2003 TEPRSSC meeting, Lillian Gill, Senior 

Associate Director, CDRH, presented an update on a number of 

issues. This was followed by presentations and discussion on a 

number of topics, including sunlamps, security systems, and 

fluoroscopy. 

Dental X-Ray Examinations

OHIP, in conjunction with the American Dental Association (ADA) 

and numerous dental specialty organizations, began revising the FDA 

recommendations entitled "The Selection of Patients for X-Ray 

Examinations: Dental Radiographic Examinations." These 

recommendations were first published in 1987. They provided 

suggestions to reduce unproductive radiographic examinations, that is, 

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OHIP FY 2003 Annual Report, page 36 

 

dental exams that do not yield information beneficial to patient 

management. The recommendations assist the dentist in deciding 

when a radiograph is appropriate. While these recommendations are 

still valuable today, the ADA requested collaboration with FDA to 

revise the recommendations to represent state-of-the-art thinking 

about dental radiographic imaging. The revised recommendations are 

expected to be published by FDA and the ADA by Summer 2004. 

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 FY 2003, 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; 

• calibrated 22 radiation survey instruments on a semi-annual 

basis; 

• conducted the annual training required for all licensed materials 

users; and 

• facilitated and chaired quarterly radiation safety committee 

meetings. 

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 FY 2003 Annual Report, page 37 

 

Also, during FY 2003, 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, have led to continuing, significant reductions in the amounts 

of hazardous materials stored by CDRH (see table below). 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. 

 

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 FY1999-01 FY2002 FY2003 

Containers of liquid radioactive 

waste 30 40 8 1 1 

Sealed Drums of dry radioactive 

waste 3 3 0 0 0 

Drums of “Decay-in-Storage” 

waste2 3 3 2 1 0 

Sealed radiation sources3 200 200 9 3 3 
OHIP FY 2003 Annual Report, page 38 

 

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 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 research 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. 

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 FY 2003 Annual Report, page 39 

 

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 life-cycle of a medical device. Our Human 

Factors efforts impact on the Center’s premarket, 

postmarket, and field-inspection regulatory missions. 

During FY 2003: 

• We assisted the Center’s Office of Device 

Evaluation by providing several Human 

Factors reviews for PMA and 510(k) 

devices. 

• We redesigned the Human Factors 

Website to help visitors find information 

about FDA's Human Factors Program. 

This website consolidates all human factors 

and use error information into one cohesive 

website. It gives links to key guidance 

documents and publications, and explains the 

role of human factors in the safe use of 

medical devices. 

• We created a Human Factors Program 

Display to promote the Human Factors 

program more widely within the Agency. The 

display includes sections on: What is Human Factors?; Why 

is Human Factors Important?; What are some examples of 

Human Factors Problems?; and, What is FDA Doing 

(Human Factors program goals)? 

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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 FY 2003 Annual Report, page 40 

 

Labeling

Improved patient labeling on medical 

devices allows the patient or caregiver to 

better understand both instructions for use 

and risk-benefit information. OHIP 

reviews patient labeling for all new 

Premarket Approval (PMA) submissions 

and also for 510(k) and HDE submissions 

when CDRH's Office of Device Evaluation 

(ODE) determines that the patient labeling 

for a device is particularly important. 

When patient labeling is not provided as part of a pre-market 

submission, OHIP reviews the application to determine if labeling 

would contribute to reducing use error or allow the patient to make a 

more informed choice concerning their healthcare. During 2003, we 

reviewed 102 labeling submissions. This was the eighth year that 

OHIP has worked with ODE to perform these reviews. 

Electronic Labeling 

One important example of a new way the FDA will provide 

information on the products it regulates is through an electronic 

product label. During FY 2003, OHIP conducted usability research in 

best practices for the presentation of electronic labeling 

On November 18, 2003 we hosted the "Medical Device Electronic 

Labeling Conference." The purpose of the conference was to add to 

our knowledge base about current best practices for conveying 

medical device information electronically to health care professionals, 

patients, and consumers. Five experts from the public and private 

sector presented information about research-based web design and 

usability guidelines, user-centered design issues, and writing style and 

format for web-based applications. Attendees included representatives 

from all the Centers. Next steps include: 

• a summary report of the conference; 
OHIP FY 2003 Annual Report, page 41 

 

• a heuristic assessment of an ideal prototype of electronic labeling; 

and 

• a usability test comparing an ideal prototype of electronic labeling 

to a model version of paper-based labeling presented on the web. 

Use Error Model

OHIP developed a model of use errors based on real-world experiences of 

nurses, biomedical engineers, and home users who use a variety of medical 

equipment. The model was also based on known examples of use errors 

from literature and experience within CDRH, and a few from human factors 

(HF) in other industries (but which could apply to medical devices). The 

model proceeds from a previous projected called Prioritization and 

Reduction of Use Error in Devices (PROUD) 2000. It was developed with 

the assistance of an outside contractor who held discussion groups with 

visiting and traveling nurses and evaluated the results. 

The current model, called UPCARE, consists of four main components: 

Unmet User Needs, Perception, Cognition, and Actions. 

These four broad categories represent all cases of use error that have been 

collected and each is broken down further within the model into subcategories. The categorizations are based on actual experiences of users and 

known use problems. UPCARE represents the only known descriptive 

model of use-errors with medical devices and was presented at the 8th 

Annual International Conference of Industrial Engineering Theory 

Applications and Practice in Las Vegas in 2003. Upon completion of this 

work, we will provide a source of specific and useful information for 

manufacturers, adverse event reporters and evaluators, reviewers of new 

device submissions, and device users. As such it will help guide design 

refinements in medical equipment and support other strategies for errorreduction. Perhaps most useful, it presents a consistent and coherent 

structure and vocabulary for discussing and understanding instances of 

medical device use error, which is currently lacking in government, industry 

and the user community. 
OHIP FY 2003 Annual Report, page 42 

 

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 FY 2003, OHIP lawyers and paralegal staff were instrumental in 

allowing CDRH to: 

• meet all statutory requirements associated with 

implementation of the Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA); 

• respond to 11 citizens petitions, with no overdue petitions; 

and 

• publish 61 Federal Register documents. Some of the most 

significant documents include: 

3⁄4 Patient Examination and Surgeons’ Gloves. This 

proposed rule would establish new test procedures and 

acceptance criteria for leakage testing of patient 

examination and surgeons’ gloves. It would also tighten 

the criteria to conform to international practices and to 

assure the quality of gloves. 

3⁄4 Performance Standard for Diagnostic X-Ray Systems 

and their Major Components. This proposed rule 

would update the standard to account for changes in 

technology and use of radiographic and fluoroscopic 

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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systems as well as to fully utilize the currently accepted 

metric system of units in the standard. 

3⁄4 Reprocessed Single-Use Devices: Submission of 

Validation Data. In accordance with MDUFMA, this 

notice listed the critical reprocessed single-use devices 

for which FDA was terminating an exemption from the 

510(k) requirements and for which reprocessors needed 

to submit validation data. FDA also made available a 

guidance document to assist in the submission of 

validation data. 

3⁄4 Classification of Human Dura Mater. CDRH issued a 

proposed rule to classify human dura mater into class II 

(special controls). At the same time, CDRH made 

available a draft guidance document that would serve as 

the special control for the device, once it is classified. 

The regulation workload in FY 2003 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. 
OHIP FY 2003 Annual Report, page 44 

 

In FY 2003, OHIP: 

• Updated and maintained a comprehensive database of all 

guidance documents issued by CDRH – currently, more than 

778 guidance documents prepared under GGPs. 

• Published 53 notices of availability for guidance documents. 

• Updated and revised the Standard Operating Procedures 

(SOP) Manual for GGPs, including 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.

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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 FY 2003 Annual Report, page 45 

 

During FY 2003, OHIP: 

• 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. 

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

simple. 

• Provided plain language review for 30 one-page summaries written by 

CDRH about newly approved and cleared devices which include new and 

emerging technologies. 

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

CDRH staff. 
OHIP FY 2003 Annual Report, page 46 

 

MEDICAL DEVICE USER FEES 

MODERNIZATION ACT (MDUFMA) 

The Medical Device User Fee and Modernization Act of 2002 

(MDUFMA), amends the Federal Food, Drug, and Cosmetic Act (the 

Act) to provide FDA important new responsibilities, resources, and 

challenges. MDUFMA has three particularly significant provisions: 

• User fees and performance goals for premarket reviews 

of PMAs, PDPs, premarket reports (a new category of 

premarket application for reprocessed single-use devices), 

certain supplements, and 510(k)s. These fees, together with 

additional appropriations, are intended to allow FDA to 

make significant improvements to review evaluation 

processes, reducing the time required to make new medical 

technologies available to health care professionals and 

patients. 

• Establishment inspections may be conducted by 

accredited persons (third-parties), under carefully 

prescribed conditions. 

• New regulatory requirements for reprocessed single-use 

devices, including a new category of premarket submission, 

the premarket report. 

These and other important provisions of MDUFMA affect many 

aspects of various CDRH and OHIP programs. 

OHIP’s Responsibilities

During FY 2003, OHIP provided extensive support to CDRH 

stakeholders and staff to implement the many provisions of 

MDUFMA. These included: 

• Stakeholder Education and Training: MDUFMA provides for 

the education and training of stakeholders and requires that FDA 

hold an annual stakeholder meeting. During FY, 2003, OHIP 

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OHIP FY 2003 Annual Report, page 47 

 

created the MDUFMA website; developed summary materials for 

the public regarding MDUFMA; provided a “User Fee 

Teleconference” in April 2003; mailed a letter on the new User 

Fees to 30,000 medical device establishments; and, prepared for 

the First Annual Stakeholder Meeting that will take place in 

December 2003. 

• Regulations and Guidance: In order to assure timely 

implementation of the MDUFMA requirements, OHIP provided 

extensive support for regulations and guidance development. 

Fifteen guidance documents were drafted under MDUFMA to 

provide staff and stakeholders with needed information and 

instructions. All MDUFMA deadlines have been met. 

• Science Education: In order to provide CDRH staff with the 

information and skills needed to meet MDFUMA goals, OHIP 

provided 44 scientific courses on diverse technical areas. There 

were more than 1,000 attendees at the courses (individual CDRH 

staff members may have attended more than one course). 

• Small Business Determinations: MDUFMA mandated that 

medical device manufacturers must now pay a fee for each 

premarket application (PMA), premarket report, PMA supplement, 

or 510(k) submitted for review, unless they are eligible for a 

waiver or exception. Establishments that meet requirements for 

FDA designation as a “Small Business” pay a reduced or waived 

fee. OHIP established and administers the program for making the 

small business determination under MDUFMA. In FY’03, 135 

Small Business Determinations were made between March 5 and 

September 30, 2003. Of these, there were 10 denials. 

• MDUFMA Third Party Inspections: The Medical Device User 

Fee and Modernization Act of 2002 (MDUFMA) was signed into 

law by the President on October 26, 2002. Section 201 of 

MDUFMA establishes a new subsection "g" to section 704 (Factory 

Inspection) of the act, which requires FDA to accredit third parties 

(Accredited Persons, a.k.a. APs) to perform inspections of eligible 

manufacturers of Class II or III devices. MDUFMA requires the 

agency to publish in the Federal Register, not later than 180 days 

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OHIP FY 2003 Annual Report, page 48 

 

after the date of enactment, criteria to accredit or deny accreditation to 

persons who request to perform the duties of an AP. 

 These criteria were published in the Federal Register on April 28, 

2003 at 68 FR 22400 and in the guidance "Implementation of the 

Inspection by Accredited Persons Program Under The Medical 

Device User Fee and Modernization Act of 2002; Accreditation 

Criteria." 

During FY 2003, OHIP received 23 AP applications from 22 

organizations. Because MDUFMA limits the number of APs to 15 in 

the first year, we prepared a “Rating and Ranking” checklist to assist 

in evaluation of the AP applications. After acceptance of the 

applications as well as formal classroom training and joint training 

inspections with the FDA, the approved APs will be able to conduct 

inspections in early FY 2004. 

• Accredited Persons (AP) 510(k) Reviewer Program: The 

Accredited Persons Program was created by the FDA Modernization 

Act of 1997 (FDAMA), based on an FDA pilot. The purpose of the 

program is to improve the efficiency and timeliness of FDA's 510(k) 

process, the process by which most medical devices receive marketing 

clearance in the United States. Under the program, FDA has 

accredited third parties (Accredited Persons) that are authorized to 

conduct the primary review of 510(k)'s for eligible devices. Persons 

who are required to submit 510(k)s for these devices may elect to 

contract with an Accredited Person and submit a 510(k) directly to the 

Accredited Person. The Accredited Person conducts the primary 

review of the 510(k), then forwards its review, recommendation, and 

the 510(k) to FDA. By law, FDA must issue a final determination 

within 30 days after receiving the recommendation of an Accredited 

Person. 510(k) submitters who do not wish to use an Accredited 

Person may submit their 510(k)'s directly to FDA. 

In an effort to encourage greater use of the Accredited Persons 

Program, FDA implemented an expansion pilot in January 2001 that 

allows Accredited Persons to review many Class II devices that were 

not previously eligible. The pilot allows, subject to certain conditions, 

Accredited Persons to review Class II devices for which there are no 

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device-specific guidance documents. Information on the expansion 

pilot, including criteria allowing for the review of these Class II 

devices, can be found in a guidance document entitled, Guidance for 

Staff, Industry and Third Parties: Implementation of Third Party 

Programs Under the FDA Modernization Act of 1997. 

This guidance is a revision of the October 30, 1998 guidance 

document with the same title. Accredited Persons and other interested 

parties should refer to Section II.B., Purpose and Nature of the 

Program, for the criteria that would allow for the review of the Class 

II devices in the expansion pilot. 

During FY 2002, 510(k)'s reviewed by Accredited Persons received 

FDA marketing clearance in an average of 77 days after initial receipt 

by the Accredited Person — 29% faster than comparable 510(k)'s 

reviewed entirely by FDA. In addition, submissions reviewed by 

Accredited Persons are not subject to FDA user fees, while 510(k)'s 

sent directly to FDA are subject to a fee of $2,187 in fiscal year 2003. 

Most Accredited Persons have specialized expertise in areas that may 

be helpful to 510(k) submitters, such as device testing, standards, or 

foreign regulatory requirements. Further, Accredited Persons have 

headquarters throughout the United States, in Europe, and in Taiwan, 

and have additional offices elsewhere, so they often can provide local 

service. 
OHIP FY 2003 Annual Report, page 50 

 

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 FY 2003, 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. 

This training was presented in a variety of settings and formats: 

• Over 177 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 

four to forty hours. The longer courses may spread over a 

period of several weeks. 

• Thirty-four satellite teleconferences were offered and 

attended by over 330 CDRH employees. 

 

4

 There were approximately 1,050 CDRH employees in FY2003. 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 that enhances their job performance and 

maximizes their career potential. 
OHIP FY 2003 Annual Report, page 51 

 

• 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 increased the number of on-line course offerings to 

over 600 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. 

Academic Partnerships 

We introduced the Continuing Science Education Program at the 

end of FY 2003. This program is designed to encourage continual 

learning and to provide eligible employees with the opportunity to 

enhance their overall scientific knowledge and the unique integration 

of science and regulatory affairs. 

The Continuing Science Education Program has two separate 

components that are based on academic partnerships with local 

institutions of higher learning. Both programs require 30 academic 

credit hours over a 2 year time period. 

• The Science Education Leadership Program (SLEP) is 

offered for managers. It is presented in collaboration with 

Georgetown University and Virginia Polytechnic Institute. 

The curriculum consists of a compilation of courses focused 

on clinical science, device science and science management 

and policy. Specific courses include: Ethical Issues in 

Scientific Research; Risk Assessment; Biomaterials; New 

Product Development and Management; and, Applied 

Biostatistics. 

• The Basic Science Education Program (BSEP) is offered 

for non-managers in collaboration with Montgomery 

College. The curriculum includes basic science courses in 

biology, anatomy and physiology, genetics, biotechnology, 

and medical terminology. 
OHIP FY 2003 Annual Report, page 52 

 

Course Highlights 

Course highlights during FY 2003 include: 

• Core Competencies for CDRH Staff College: This 

program is under development with a contractor. Draft core 

competencies have been identified based on information 

from focus groups and surveys. A draft model of 

competencies has been developed and will be validated 

Center-wide. 

• CDRH Leadership Forum: This program introduces a 

new series of speakers and workshops to the Center. The 

forum provides leadership training opportunities to all 

CDRH Managers with supervisory responsibilities. It is a 

series of five leadership topics and includes a mix of half 

day lectures and full day workshops. A live satellite 

broadcast was also included. Each topic in the forum 

addresses one or more core competencies as outlined in the 

CDRH Managerial Core Competencies and Learning 

Pathways Program. 

• Mentoring for New Managers: This one-year pilot was 

administered in FY 2003. The participants in the program 

and their supervisors have submitted evaluations based upon 

their experiences. The pilot program was initiated from the 

CDRH Strategic Plan within the Magnet for Excellence 

Goal. It was considered a way to develop a skilled and 

talented pool of managers while ensuring continuity of 

knowledge and skills base. The value of the program is 

under review and results from the evaluations will determine 

the future of the program. 

• Meet the Experts Seminar Series: This program includes 

targeted Science Seminars to provide an opportunity for 

CDRH staff to interact with nationally recognized experts. 

The seminars with external experts enable staff to stay 

abreast of recent discoveries with the added benefit of 

accelerating product reviews. Cardiovascular research was 
OHIP FY 2003 Annual Report, page 53 

 

the first area targeted. The speakers highlighted their 

perspective on new developments and progress in the 

treatment of circulatory disease and the role of emerging 

technology reviewed by CDRH. Neurology was the second 

area targeted. 

• Anatomy and Physiology: This eight week course was 

offered to CDRH employees with or without formal 

biological/medical training and provided a comprehensive 

overview of human anatomy and physiology. 

• Basic Industrial Sterilization of Medical Devices: This

ten week course covered technologies used for industrial 

sterilization of medical devices and validation of 

sterilization processes. The course provides participants 

with a basic understanding of the principles of sterilization, 

the various methods of industrial sterilization, sterilization 

validation, and other activities associated with sterilization. 

• Principles of Medical Device Measurements and 

Electronic Instrumentation: This nine week course 

addresses the basic principles in the area of medical device 

measurements and electronic instrumentation. It is offered 

to CDRH regulatory review and laboratory 

scientists/engineers, other than electrical engineers, who 

want to enhance or refresh their skills in this area. 

• CDRH Clinical Trials: This course offers a comprehensive 

perspective on the use of clinical trials in the development of 

medical devices. It provides attendees with a working 

knowledge of regulatory, clinical and statistical issues of 

trial design. Lecturers included speakers from CDRH, other 

FDA offices, academia, and industry. This provided the 

broadest perspective possible on the challenges and practical 

real-life applications for both regulators and manufacturers. 

• Emergency Preparedness: This course was offered to 

members of the CDRH Emergency and Disaster Teams. It 

covered member’s roles and responsibilities, provided 
OHIP FY 2003 Annual Report, page 54 

 

descriptions of each of the four (4) triage categories, and 

familiarized members of the teams with the 

emergency/disaster checklists. 

• Strokes: Pathology, Physiology, Imaging, Therapy and 

Treatment: This was a course that provided participants 

with an introduction to neuroanatomy and pathophysiology. 

This includes the functional areas of the brain, arterial 

supply and venous drainage, and a description of the 

pathology underlying stroke and transient ischemia. It also 

included an introduction to modern neuroradiology, 

including the basic concepts behind computed tomography 

(CT) and magnetic resonance imaging (MRI), and described 

how each is employed in diagnosing and quantifying stroke. 

• Case Studies in Managing the CDRH Program: This 

course is for CDRH managers, team leaders, and senior 

professionals who have major roles in managing Center 

programs or regulatory issues. It provides managers and 

senior professionals who tackle recurring and new Center 

programs/issues with the advantage of the perspectives and 

experiences of senior Center employees who have already 

faced these issues. 
OHIP FY 2003 Annual Report, page 55 

 

TELECONFERENCE/VIDEO PRODUCTION

OHIP operates an ALL 

DIGITAL 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 FY 2003; 

• 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: 

3⁄4 we produced a total of 32 teleconferences for FDA and 

other government agencies on a wider variety of topics; 

3⁄4 we provided technical video support for Centersponsored medical device panel meetings; 

3⁄4 we provided video documentation of critical CDRH 

meetings and training events; and 

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 FY 2003 Annual Report, page 56 

 

3⁄4 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. 

Our website for television and 

video services continues to be a 

comprehensive source of 

information regarding our 

television and related video 

services. 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 FY 2003: 

• We completed a six year, 1.5 million dollar conversion of the 

studio from analog to digital. All funds for the conversion were 

secured through chargebacks for programming – no direct cost to 

CDRH. Digital conversion was driven by the state of technology, 

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the alternative would have been an outdated technical plant that 

would prove very costly to maintain. Our all digital output means 

that programming can be distributed via any digital medium – 

broadcast TV, satellite, internet, CDROMS, etc. 

• Production of FDA Patient Safety News (PSN) continued into its 

second year. FDA PSN is a monthly video news show for health 

care personnel, carried on satellite broadcast networks aimed at 

hospitals and other medical facilities across the country. It features 

information on new drugs, biologics and medical devices, on FDA 

safety notifications and product recalls, and on ways to protect 

patients when using medical products. FDA PSN has made 

significant progress in the past year. 

3⁄4 Starting with the November 2002 show (#10), PSN 

realized its goal of incorporating all medical product 

centers into the program. CBER and CDER have been 

active partners and have made significant contributions to 

the program. PSN also has been able to occasionally 

include stories from other FDA centers. For example, it 

recently completed a story from CFSAN on the new 

trans-fatty acid labeling. In February 2004, PSN will 

reach the two year mark with episode # 24. 

3⁄4 The show is distributed to 4 health TV networks – with a 

combined reach of nearly 4,500 hospitals. More 

importantly, the program has a website where viewers 

can view either the entire show or just a select story, find 

more information on each story, search for previous 

stories, e-mail stories to colleagues, report adverse events 

(through a link to MedWatch) and sign-up for the PSN 

listserv. The PSN website is currently receiving over 

4,000 hits each month. The webcast center, where 

viewers can watch the whole show or just a select story, 

currently receives over 2,500 requests per month. 

3⁄4 We have completed the work necessary to assure that, 

starting with the November 2003 show, viewers will be 

able to download a video story to their own computer, 

network, or even a DVD – for viewing immediately or at 

a later time. PSN has received numerous requests for 

video copies of stories for use during staff meetings and 
OHIP FY 2003 Annual Report, page 58 

 

in-services. This capability will allow users to download 

high-resolution mpeg files that can be played back either 

on a computer or TV 

3⁄4 We continued a series of broadcasts to all FDA 

employees featuring the 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. 

• 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 FY 2003 Annual Report, page 59 

 

COUNTER TERRORISM ACTIVITIES

Emergency Response

• Completed Emergency Preparedness Communication Plan 05/03. 

• Completed emergency response team training in Spring 2003. 

This training assured that 100% of CDRH public health emergency 

responders are trained in emergency SOPs. 

• Center and Agency personnel participated in the TOPOFF II 

radiological (and biological) emergency response exercise. The 

exercise tested communications, response to potential food 

contamination, and response to needs for medical devices. FDA 

staff responded adequately. 

• Updated the Emergency Counterterrorism Preparedness and 

Response Plan for radiation. 

Communication Plan

• Completed a Center-wide Emergency Preparedness 

Communication Plan and put the plan in place on May 3, 2003. 

This plan is designed to assure that CDRH will be prepared to 

respond in the face of emergency situations. 

Bioterrorism Teleconferences

• The CDRH Television Studio produced 6 national teleconferences 

on medical responses to BIO and CHEM terrorism. They 

produced 3 international teleconferences for CFSAN on FDA CT 

food imports regulations. 
OHIP FY 2003 Annual Report, page 60 

 

APPENDIX

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 

Acharya, Vasanth Frett, Udina Paras, Peter 

Appel, Sherrie A. Gagne, Stefan P. Racine, David W. 

Barr, Glen W. Garris, Cindy Rice, Lynne L. 

Brown, Karen M. Howell, Heather D. Sullenger, Deborah C. 

Dennis, Malcolm M. Joseph, Lireka P. Vitale, Kimberly J. 

Evans, Clifford D. Marshall, Lowell J. 

Cassis, Domini H. Hanna, Myrna A. Sheehan, Joseph M. 

Fischer, Ruth A. Knight, Jacqueline E. Wade, Jennette 

Gilmore, Rosa M. Noland, Bernice E. 

Brier, Marjory F. Hanna, Mary R. Sauer, Patrice 

Brotman, Renee A. Hohman, Stephen T. Scott, Nancy J. 

Choi, Simon T. Morch, Cecile A. Stewart, Laura L. 

Gerhold, Susan H. Nesseler, Steven E. Nakon, Kimberly K. 
OHIP FY 2003 Annual Report, page 61 

 

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. Gray, Katerine M. Rose, Stanley C. 

Boyce, Wallace C. Jefferson, Arnette L. 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. Davis, Sharon M. Moyal, Albert E. 

Akey, Catherine L. Divine, Michael P. Noska, Michael A. 

Ali, Fiad M. Finder, Charles A. Ohlhaber, Thomas 

Appleby, Suzanne E. Franke, Kathleen A. Pack, Randy F. 

Ashby, Kimberly A. Friend, Wesley A. Ratskoff, Ellyce F. 

Barr, Helen J. Gunzburg, Charles R. Robinson, Denise J. 

Belella, Stephanie L. Haran, Timothy J. Shandruk, Petro 

Bennaugh, Nancy T. Hoage, Patricia A. Sheridan, Kathleen M. 

Boyce, Penny R. Jernigan, Vickie H. Spelic, David C. 

Burkhart, Roger L. Joseph, Jeankite Stern, Stanley H. 

Chakrabarti, Kishalaya Kaczmarek, Richard V. Thompson, Donald L. 

Chesemore, Kaye F. Lively, Charles E. Trammell, Dennis L. 

Chissler, Pamela G. McCrohan, John L. Wandell, Evelyn P. 

Choy, Joanne K. Mourad, Walid G. Wei, Stella D. 

 Wynne, Nancy M. 
OHIP FY 2003 Annual Report, page 62 

 

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 

Albershiem, Harriet B. 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. 

Lowe, Nancy S. Pijar, Mary Lou Tolbert, Margaret T. 

Kaye, Ronald D. Rachlin, Jay A. Weiss, Ruth 

 Rooks, Cornelia B. Witters, Alicia L. 

 Sawyer, C. Richard Wollerton, Mary Ann 

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

Allen, Gene E. Nelson, Marie C. Strojny, Judith L. 

Auerbach, Jessica B. Park, James J. Sutton, William M. 

Balham, Ronda A. Parr, Ronald P. Taylor, Tawana V. 

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

Cardamone Thomas E. Puleo, Joseph V. Weller, Phyllis S. 

Clark, Geoffrey S. Raines, Joyce A. Yellin, Arthur K. 

Daly, Connie Rodgers, Anthony E. 

Fedorchak, Carol M. Snesko, Walter M. 

 Leonard, Nancy M. Stellar, Barbara P. 
OHIP FY 2003 Annual Report, page 63 

OHIP Organization Chart