OCD FY2006: FDA Goal 4 - Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century
CDRH is integrally involved in FDA-wide efforts to create a stronger, more unified Agency. The increasingly complex regulatory mission of the FDA requires improved business practices to create efficiencies, standardize processes, enhance infrastructure, and improve planning. CDRH FY 2006 efforts to augment FDA’s mission in the 21st Century included IT enhancements, development of an operational plan, expanded training for staff, and attention to homeland security.
Efficient and effective management is necessary to support CDRH programs.
Medical Device Postmarket Transformation Initiative
Assuring the postmarket safety and effectiveness of medical devices which may remain in use for 10–20 years is a daunting task. In January 2006, as the result of an internal review of CDRH postmarket tools and processes, the Center issued a comprehensive report on the Medical Device Safety Program. In response to the report, the Center convened a Postmarket Transformation Leadership Team (PTLT) composed of CDRH senior staff and external medical experts to consider recommendations to make the Center’s postmarket program more comprehensive and timely. The recommendations focused on four areas designated for improvement:
- Create a culture of collaboration to improve joint efforts within and without the Center to identify and solve postmarket problems;
- Develop world class data sources and systems to more rapidly recognize, analyze, and track device usage problems;
- Enhance risk/benefit communication efforts to quickly and clearly share postmarket information with practitioners, patients, and consumers; and
- Increase collaboration to improve enforcement strategies and outcomes.
The PTLT met several times from January to September 2006, recommending actions under each area and suggesting next steps to achieve postmarket transformation.
CDRH Operational Plan
The Center concluded FY 2006 with development of a CDRH operational plan. The purpose of the plan is to provide the Center with a roadmap aligning CDRH’s strategic goals with those of the FDA. CDRH is the first among FDA centers to develop a comprehensive, strategic operational plan linking mission to objectives, actions, and performance measures.
Communications Improvement Initiative
During the fiscal year, CDRH conducted an evaluation of internal communications processes. Interviews and focus groups with management and staff were used to identify processes working well and areas needing improvement. CDRH is evaluating recommendations to determine a workable plan for improving Center-wide communications, and to support CDRH and FDA external communications goals.
IT systems allow for better tracking and monitoring of medical devices throughout the total product life cycle. CDRH continued working in FY 2006 to ensure that IT projects are consistent with the Center’s strategic goals and priorities. Efforts to map out 60 business processes and determine cross-cutting functions and IT support needs contributed significantly to development of the first CDRH IT Strategic Plan.
IT enhancements initiated during FY 2006 included systems development for submissions, review, and tracking.
In support of the Expanded Electronic Government Initiative of the President’s Management Agenda (PMA) and information collection requirements of the Bioterrorism Act, CDRH completed the design phase and began implementation of the FDA Unified Registration and Listing System (FURLS). FURLS will allow for electronic submissions from industry and result in significant savings for CDRH in contract costs.
- CeSub eSubmitter
After a very successful pilot program for the in vitro diagnostic device industry [Turbo 510(k)] and for the electronic product industry (eRadHealth), CDRH improved submission software to produce a new e-tool called CeSub eSubmitter. CeSub eSubmitter is free software that allows sponsors to complete and submit submissions electronically. Since the roll out of the CeSub software applications, CDRH has received well over 100 IVD 510(k) submissions, almost entirely from new companies, as well as over 100 electronic product submissions.
To increase electronic product industry use of the CeSub software, CDRH is enclosing a CeSub flyer with acknowledgement letters sent in response to reports received from industry. Manufacturers are also referred to the CDRH website for information on how to comply with requirements and encouraged to download the software.
During FY 2006, CDRH also increased the number of electronic submission templates for the Radiological Health Program.
Industry can now submit applications electronically for a larger number and variety of products. Electronic submissions improve the review process and result in reduced costs and time for both industry and the FDA.
- Rad Health Processor (RH Pro)
CDRH began development of an electronic document processing system, RH Pro, to replace the legacy data system used since the beginning of the radiological health program. RH Pro facilitates storage and management of both scanned paper and electronically submitted reports and correspondence on electronic products and manufacturers.
- eCopies Program
CDRH initiated the eCopies program to encourage sponsors of premarket medical device submissions to include a copy of their submission in the prescribed electronic form along with the required paper copies. During the fiscal year, 2,374 premarket submissions (2,376,036 pages) were scanned off site and received through the FDA Gateway.
As part of FDA commitment to improve procedures and move toward an e-government environment, CDRH is shifting from paper to electronic review. CDRH participated in the development of Center-wide procedures for use of the software Documentum for the review of Premarket Approval Applications and provided training to reviewers and consulting reviewers to ensure uniform implementation. Further, procedures were developed to allow electronic archival and review of electronic product Radiation Safety Reports. CDRH also participated in a Business Process Improvement initiative to map out the current review process and propose options to improve the review process by integrating electronic review tools.
- Export Certificates
CDRH began planning an electronic program for processing and issuing export certificates. On average, CDRH produces 2,280 certificates per month.
- Center Tracking System (CTS)
FDA Office of the Commissioner and FDA Office of Combination Products began use of the CDRH Tracking System (CTS) for managing/tracking combination products requests for designation (RFD). CDRH also deployed enhancements to CTS to support business processes and rules across the total product life cycle of medical devices. In addition, the Center completed enhancements to the device nomenclature management system (DNMS) and completed development of the electronic consultations tracking (eConsult) module of CTS.
The tracking capabilities provided by CTS, electronic document archival provided by Documentum, and the electronic submission and control capabilities provided by CeSub and RH Pro will provide a paperless document control and review process for electronic product submissions.
- Compliance Operations and Program Support System
CDRH implemented the first phase of the Compliance Operations Program Support (COPS) workflow management system and integrated it into the Center Tracking System (CTS). The new COPS-CTS component will track regulatory actions and their outcomes and will improve workflow management and tracking capabilities.
- Premarket Modernization Program (PMP)
CDRH initiated the Premarket Modernization Program (PMP) to update and optimize access to CDRH’s data through the creation of a total product life cycle (TPLC) data warehouse. Initially the warehouse will be loaded with premarket data, but it is designed to eventually include postmarket and compliance data.
- Electronic Medical Device Reporting
CDRH initiated development of a program to modernize the data entry process for adverse events and for accepting and processing electronic adverse event reports (eMDR) using the Health Level Seven Individual Case Safety Report (HL7 ICSR) message format. This will allow for more rapid transfer of adverse event reports to the clinical analyst for review and possible action. When the system is fully produced, implemented, and used by the manufacturing firms, it will reduce data entry costs by over 50 percent.
- Postmarket Studies Tracking
CDRH worked with a contractor to develop the Conditions of Approval tracking database for all post approval studies January 1, 2005, and forward. The database automatically keeps track of due dates; the status of studies will be placed on a web posting for the public.
Training CDRH Staff
Recruiting and training of scientists and health professionals in technologies is crucial for CDRH to accomplish its public health mission and to create and maintain an excellent workforce. Training and continuing education for CDRH staff is also important to enhance job performance and maximize career potential.
Seven hundred thirty-six (736) CDRH employees attended 2,333 Staff College courses - an average of 3 courses per employee. The Staff College presented 126 different courses: 17 percent in law and policy, 36 percent in science, 29 percent in professional development, and 18 percent in leadership.
New Employee Orientation Program
Gateway to Success is CDRH’s orientation program for new employees. Administered by the Office of Communication, Education, and Radiation Programs (OCER) Staff College, Gateway to Success consists of several program components.
- The New Employee Toolkit is a hard copy resource given to new employees on their first day in CDRH. The toolkit contains an overview of Gateway to Success, background information on CDRH, a map of CDRH facilities, a new employee checklist, and contact information.
- The Peer Guide Program pairs new employees with more seasoned employees who are equipped to answer questions and share information about their experiences at CDRH. Peer guides are provided with the brochure CDRH Peer Guides: Tips for Communicating with Your Assigned Peer.
- Discovery Portal is an online portal accessed through the Staff College’s Learning Management System. The website has links to both FDA and CDRH administrative, personnel, and organizational information; a repository of forms; facility maps; and a checklist for new employees.
- Gateway to Success resources for supervisors include Supervisor Checklist for Welcoming New Employees and Supervisor Talking Points for Meeting with New Employees.
- Gateway to Success classroom training includes interactive exercises and dialogue designed to help new employees reflect on their first few months as a CDRH employee and understand their role relative to CDRH’s mission. The training also provides guidance on career development at CDRH.
Competency Development Program
During FY 2006, CDRH implemented a voluntary Competency Development Program for staff. The program is based on nine core business and science competencies:
- Computer skills and knowledge
- Critical thinking
- Ethics and integrity
- Medical and radiation products and devices
- Organizational knowledge
- Scientific, medical, and radiation terminology
- Time management
The Competency Development Program will help CDRH managers assess staff needs and pinpoint training and development opportunities to equip staff to achieve the mission and goals of CDRH.
CDRH Leadership Programs
During FY 2006, CDRH continued to develop the skills of existing leaders and foster the growth of the next generation of Center leaders. CDRH leadership programs offer senior staff executive coaching opportunities and annual 360 degree feedback. Motivated, highly skilled non-managerial staff are competitively selected to participate in the Center’s Leadership Readiness Program.
The Division of Communications Media (DCM) within CDRH’s Office of Communication, Education, and Radiation (OCER) Programs produces satellite broadcasts and video productions for diverse clientele in the federal government and the private sector. During FY 2006, DCM provided 8 hours of mission-related programming every day to CDRH employees via the CDRH fiber-optic network, including 37 educational and training programs received live via satellite and delivered simultaneously. They also produced 18 teleconferences for FDA and other government agencies on a wide variety of topics. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/DivisionofCommunicationMediaFDATVStudio/default.htm
CDRH’s accomplishments play a critical role in securing the homeland and protecting the public from excessive radiation exposure and radiological terrorism.
Radiological Counterterrorism and Radiation Safety
During FY 2006, CDRH consulted with fellow FDA Centers, and state and federal partners to address radiation safety of security screening and defense products.
- CDRH participated in measurement instrument testing with the Transportation Security Administration (TSA) and helped revise radiation safety training that TSA is preparing for its security staff working with security screening products.
- CDRH participated in the Interagency Steering Committee on Radiation Standards (ISCORS) to develop a federal guidance entitled Guidance for Security Screening of Humans Utilizing Ionizing Radiation.
- CDRH worked with the Federal Aviation Administration (FAA), the Department of Homeland Security (DHS), the Department of Defense (DoD), and industry representatives to evaluate the safety of air-based and ground-based laser anti-missile defense systems to protect commercial air traffic.
- Hurricane Response Assistance
CDRH deployed five staff members to assist with FDA’s efforts in response to Hurricanes Katrina, Rita, and Wilma. In addition, CDRH emergency team members actively participated in operations to supply regulatory and other helpful medical device and safety information for use post hurricane to FDA’s Emergency Operations Center (EOC) and ultimately to emergency personnel, public health professionals, and consumers.
- Rapid Response Team to Combat Pandemic (Avian) Flu
In response to the emerging threat of pandemic (avian) influenza, FDA announced the formation of a Rapid Response Team. In the event there is an avian flu outbreak in the United States, the team, including representatives from CDRH, will assist in locating and monitoring stockpiles of medical devices that will be in high demand but may be in short supply. In addition, the Rapid Response Team will work collectively with other healthcare centers and FDA’s Office of Counterterrorism Policy and Planning (OCTTP) to resolve regulatory policy issues that may occur prior to and during an influenza pandemic.