FY 2005 OCER Annual Report - Education
OCER specializes in educating industry about FDA laws and regulations regarding Medical Devices and Radiation Emitting Products. The most fundamental assistance that OCER provides to industry is education on how to put together an application, whether it is a PMA, 510(k), or an HDE. OCER also educates industry on the resources CDRH has available for them.
Device Advice is a CDRH self-service Web site for medical device and radiation emitting product information. This Web site provides technical assistance to small medical device manufacturers and accessible feedback to industry, health professionals, and consumers.
During FY 2005, OCER collaborated with other organizations in presenting 12 workshops for industry and manufacturers. The workshops allow us to meet face to face and exchange information on topics such as regulatory requirements, Quality Systems, and import and export requirements. We participated in the following workshops:
- October 12-13, 2004 – RAPS, Washington, D.C.
- November 18, 2004 – MDUFMA, Rockville, MD
- January 10-13, 2005 – MD&M West, Anaheim, CA
- February 15, 2005 – AdvaMed, Orlando, FL
- March, 24, 2005 – RAPS, San Francisco, CA
- April 19, 2005 – OIVD 510(k) Workshop, Rockville, MD
- May 5, 2005 – Department of Commerce (DOC), Washington, D.C.
- May 9-13, 2005 – AAMI, San Diego, CA
- May 16-20, 2005 – AAMI, Miami Beach, FL
- June 13-15, 2005 – MD&M East, New York, NY
- September 18-23, 2005 – AAMI, San Antonio, TX
- September 28-30, 2005 – FDA Workshop, Los Angeles, CA
Foreign Manufacturers Assistance
OCER works closely with the international community to ensure they understand the FDA laws and regulations to which they must adhere. OCER’s Division of Small Manufacturer’s, International and Consumer Assistance (DSMICA) received and responded to 6,858 requests for information regarding international activities (which includes telephone, letters/faxes, and email) and attended nine international manufacturer’s meetings in support of this effort. Some meetings were held in:
- February 15-17, 2005 - MEDTEC, Germany
- April 4 - 8, 2005 - AAMI; Ireland
- June 13, 2005 - Thai FDA; Bangkok, Thailand
- June 15-17, 2005 - APEC; Bangkok, Thailand
- July 8-17, 2005 - JFDA, China
- August 23-26, 2005 - JCCT & DOC, Guangzhou, China
- August 30-31, 2005 - JCCT; Beijing, China
- September 13-15, 2005 - MEDTEC, Shenzhen, China
- September 16, 2005 - China Electronic Enterprises Association, Shenzhen, China
OCER coordinates education for foreign governments and industry on the FDA medical device regulatory process. This may involve seminars and presentation or arrangements for more in-depth learning experiences while at CDRH. OCER in collaboration with other CDRH offices participates in these activities.
OCER participates in international conferences to promote compliance with U.S. medical device regulations. During FY 2005, OCER participated in 13 international conferences and workshops.
Foreign Visitors Program
During FY 2005, OCER hosted 51 international visitors from 12 countries. The country and number of visitors are as follows:
- Canada – 11
- China – 2
- Denmark – 1
- EU – 1
- Finland – 2
- France – 4
- Ireland – 1
- Japan – 21
- Korea – 4
- Malaysia – 1
- South Africa – 1
- Taiwan – 2
The Global Harmonization Task Force (GHTF) is an international voluntary group of representatives from national medical device regulatory authorities and the regulated industry. GHTF is comprised of representatives from the United States, Canada, the European Union, Japan, and Australia. The United States is one of the five founding members of GHTF. 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. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. Study groups are responsible for the drafting of the harmonized guidance documents.
During FY 2005, OCER participated in monthly CDRH meetings to update the Center Director and coordinate activities and attended meetings of Study Group 4 on Regulatory Auditing of Quality Systems in Boston, MA and Gaithersburg, MD.
US/EU Mutual Recognition Agreement (MRA)
The United States and the European Commission (EC) have signed a mutual recognition agreement (MRA). The MRA covers a variety of “product sectors” that include telecommunication equipment, electromagnetic compatibility (EMC), pharmaceutical good manufacturing practice (GMP), electrical safety, recreational craft, and medical devices.
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.
The Sixth Annual Report of the Medical Devices Annex to the U.S. /EC Mutual Recognition Agreement (MRA), a joint report by the FDA, the National Institute of Standards and Technology (NIST) and the Commission for the European Communities (CEC) was issued December 2004. The report addressed the implementation of the Medical Devices Annex and contained accomplishments from December 1, 2003 to December 1, 2004.
OCER leads CDRH’s implementation of the medical device annex of the MRA. In FY 2005, our accomplishments include:
- completion of the Sixth Annual MRA report; and
- issuance of a letter was sent to the European Commission with a proposal to allow the MRA to proceed to the Operational Phase.
Human Factors (HF) is a large part of what OCER does in support of the Center’s mission. We assist the Office of Device Evaluation (ODE) by determining whether any Human Factors risks associated with new medical devices. As part of this effort, we have:
- given 13 presentations on human factors at non-human factors groups or meetings;
- given nine presentations at human factors conferences, e.g. Association for the Advancement of Medical Instrumentation (AAMI) and Human Factors and Ergonomics Society (HFES);
- served on HFES Policy and Planning committee and acted as a reviewer for new applicants to the Board of Certification for Professional Ergonomics; and
- provided staff to participate as a member of the HFES Medical Systems Healthcare and the Standards technical groups.
Premarket and Postmarket Assistance
In FY 2005, OCER evaluated CDRH’s process for incorporating human factors analysis into the Center's programs including Pre-Market review and Post-Market safety. The evaluation of these processes began in mid-year FY 2005 and is scheduled for completion early FY 2006.
The Human Factors Web site consolidates all human factors and use error information into one cohesive website. Links are provided to key guidance documents and publications and explains the role of human factors in the safe use of medical devices.
OCER has assisted in drafting guidance related to Human Factors. We added a Human Factors section to guidance on radiation treatment planning and added a section to draft guidance on ensuring the safety of marketed medical devices. We expect that by adding HF sections to guidance, we will assist industry in addressing human factors risks in their medical device submissions and enhance our stakeholders understanding our current thinking on the Human Factors process.
As part of our responsibility for educating CDRH staff, OCER’s Staff College produced a newly designed FY 2005 Schedule of Classes. The Schedule was introduced at the start of the fiscal year and included all scheduled course and seminar offerings planned for the upcoming year. Feedback on the schedule was positive and many Center employees were pleased to have the Schedule to help them plan their training schedules well in advance. Staff College plans to incorporate the Schedule of Classes as part of their routine business process.
Science and Regulatory
More than 56 science and regulatory courses were offered through Staff College. Examples of the courses and seminars were:
- Human Factors
This course increased understanding of human factors and human “use” error when examining new devices and postmarket information. Participants learned how human factors principles should be applied during the development of medical devices and how to be better prepared to include human factors in the evaluation of medical devices.
This two-day workshop was designed and offered to enhance the participant’s negotiation and leadership skills, withemphasis on improving outcomes for CDRH participants.
- Registration and Listing
This course instructed CDRH employees how to verify whether an establishment is registered and listed with FDA, and how the Part 807 regulations are implemented and enforced by the Office of Compliance.
- Quality Systems Training
This course was developed to provide participants with a basic understanding of the Quality System Regulation and its requirements.
- Biostatistics for Diagnostic Devices
This course instructed participants on using key terminology and ideas in statistical and probabilistic thinking in the application to diagnostic medical products.
- eRoom for PMAs
This course provided training in the Web-based software program "eRoom" and the tools needed to facilitate team communication and interaction in a central, electronic working space.
- Bayesian Statistics
This introductory course covered basic concepts of Bayesian statistics for non-statisticians. Examples from both therapeutic and diagnostic medical devices were used for the course.
Lead investigators for the ASCUS/LSIL Triage Study for Cervical Cancer (ALTS) discussed HPV (natural history and cervical carcinogenesis), provided an overview of the ALTS study design, ALTS prevalent/cumulative disease, problems faced by colposcopy, studies being developed for improving colposcopy, scope of the future and alternative visual methods.
- Introduction to Genetics
This course focused on the basics of molecular genetics from DNA structure and functions to gene regulation, emphasized the applications of molecular genetic knowledge in medicine and agriculture, and discussed current legal and ethical issues that are related to molecular genetics.
Law and Policy
More than 40 Law and Policy courses were offered through Staff College. Examples of the courses and seminars were:
- Basic Food and Drug Law Course
This interactive, 1-week course provided FDA personnel with in-depth knowledge of the Food, Drug and Cosmetic Act and court precedents that govern the Agency's activities.
- Advanced Topics in Regulatory Issues
CDRH Staff College and ODE teamed up and created this program that brought advanced topics in regulatory issues to the forefront with the goal of developing resolutions based on consensus. Not only were issues discussed, but also decisions were made as a result and posted on the Intranet.
- Establishment Registration and Device Listing
This course provided instruction to the many CDRH employees who need to understand how to verify whether an FDA regulated medical device establishment has registered and listed with FDA, and how the Part 807 regulations are implemented and enforced by the Office of Compliance.
- Leading and Participating in a Premarket Approval (PMA) Review Team
This one-day course, targeted to PMA team leaders and team members, combined technical information on the tasks associated with the major steps in the PMA process as well as instruction on the leadership and interpersonal skills.
During FY 2005, we presented over 35 leadership and professional development courses targeted to all CDRH employees. Many new classes were introduced, such as, Thinking outside the Lines, English Pronunciation for Non-Native Speakers, Crucial Conversations, The Effective Facilitator, and Grammar and Punctuation. All courses, especially the new courses, received excellent to outstanding evaluations. Demand for the new courses was so high that Staff College will repeat these courses in FY 2006.
CDRH Leadership Forum
The CDRH Leadership Forum continued to provide leadership-training opportunities to CDRH Managers. Each course addressed one or more of the core competencies outlined in the CDRH Managerial Core Competencies and Learning Pathways Program.
Continuing Science Education Program (CSEP)
CDRH implemented a Continuing Science Education Program (CSEP) to encourage continual learning and provide eligible employees with the opportunity to enhance their potential for career development and their overall scientific knowledge through the unique integration of science, regulatory affairs, and leadership. There are two components to the CSEP program, the Basic Science Education Program (BSEP) and the Science Leadership Education Program (SLEP). The BSEP component was designed for employees who have minimal science education and/or limited undergraduate experience. The SLEP component aimed to facilitate continuing science and leadership education for managers and commissioned corps officers.
During FY 2005, OCER played a lead role in addressing the Center’s Strategic goal of becoming a ‘Magnet for Excellence’. Staff College worked with a vendor and many Center participants to develop a ‘competency model’ to focus and improve CDRH professional development activities. Competencies are defined as the basic skills, knowledge, abilities, and other characteristics employees need to do their jobs. The competencies for CDRH were identified by conducting interviews, workshops, focus groups, and surveys with diverse groups of CDRH employees and managers.
CDRH’s core business and science competency model consists of nine different competencies that have been identified for CDRH employees at every level of the organization. A major step in using the core competency model is identifying developmental needs and matching those needs to available learning activities or learning pathways. OCER’s Staff College and PMO collaborated on developing a planning tool for identifying developmental needs and learning pathways. Thecompetencies and the planning tool or to be introduced to staff at the start of FY 2006.
New Employee Orientation
Staff College began work with a vendor on the development of a new employee orientation program. The new program, Gateway to Success, consists of several components that will span over the first six months for the new employee. The purpose is to welcome new employees to CDRH and ensure that they have the resources they need to launch a successful career in CDRH. The program will address logistical, cultural, and relational concerns that new employees may have and will be ready to launch during the middle of FY 2006.
OCER operates an All Digital broadcast quality television studio on behalf of CDRH and FDA. The studio is an extremely powerful tool for outreach on a wide variety of topics. The primary medium for outreach is production and presentation of “live teleconferences,” although we do videotape programming on a limited basis.
The television studio provides excellent value to CDRH and FDA. Studio operations and capital expenditures, other than personnel costs, are funded entirely by charge backs to the other components of FDA and other government agencies sponsoring the programming. During FY 2005, the OCER studio:
- produced a total of 28 broadcasts and 45 downlinks for FDA and other government agencies on a wide variety of topics
- provided technical video support for Center sponsored medical device panel meetings
- provided video documentation of critical CDRH meetings and training events
- provided 8 hours of mission-related programming every day to CDRH employees via the CDRH fiber-optic network, including 15 educational and training programs received live via satellite and delivered simultaneously
As of September 2005, the studio produced episode #43 of FDA Patient Safety News and is now in the 5 th year of production.