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OCD FY2004 Part 3. Communicating Medical Technology - CDRH Strategic Goal: Knowledge Management

Access to Information

CDRH Disease-Specific and Hot Topic Websites

CDRH’s Center-wide e-Consumer initiative is designed to improve access to electronic information. As new technology emerges, it is not only our responsibility to assure its safety and effectiveness, but also to communicate its existence and usefulness to the public at large. In FY 04 we:

Launched the Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety website website (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115904.htm), which contains information on regulatory activities, new items, and laboratory safety tips. The website also offers access to databases that provide information on products cleared for over-the-counter use, CDRH review summaries for cleared IVDs, and recent compliance actions.

Continued to develop and maintain the website on diabetes, combining information from all FDA Centers into one location for easy access and usability. The website records approximately 4,000 to 6,000 visits per month, and many government and consumer websites link directly to it. This site is now being used as a model for future disease-specific websites at FDA.

Launched the cardiovascular disease website which combines information from all FDA centers into one location for easy access and usability. This website is enhanced by extensive graphics showing the function of the healthy heart, the diseased heart, and medical interventions. It was posted in February 2004 and receives approximately 3,000 visits per month.

Launched a new website on cochlear implants ( http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/CochlearImplants/default.htm) which provides information for consumers, educators, and health professionals about the risks and benefits of cochlear implants. The site was posted in September 2004.

Published the newsletter FDA & You for the second year. This newsletter targets secondary school students and health educators. Issued three times a year, FDA & You provides information on FDA topics of interest to teenagers. In April 2004, a mailing of 62,000 postcards invited health educators and secondary school principals to read the newsletter and view it online. In November 2004, FDA & You was featured at the American Public Health Association convention in Washington, DC.

Updated the Breast Implant Handbook and the Breast Implant Brochure for consumers. Both the handbook and the brochure alert prospective breast implant recipients of the known consequences and presents pictures of three frequent adverse outcomes. Both documents are available on the internet at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/BreastImplants/default.htm.

Continued updating the Medical Device Safety website (http://www.fda.gov/MedicalDevices/Safety/default.htm), which enables health care professionals to find CDRH's medical device safety information, e.g., recalls, public health notifications, safety tips, "Dear Doctor" letter, in one consolidated website. The site is updated regularly to feature high priority risk messages. During this year, CDRH analyzed the target audience and evaluated site usability, with the aim of redesigning the site to make the information more accessible and understandable to practitioners.

FDA Premarket Decision Summary Templates

In an effort to empower consumers making decisions regarding the use of In Vitro Diagnostic Devices, such as “predicates” and diagnostic kits to be used professionally or at home, and to be consistent with CDRH’s center-wide “Knowledge Management” and “Transparency” initiatives, OIVD developed and implemented the use of a standardized Premarket Decision Summary Template across all the OIVD divisions.

The Premarket Decision Summary Template summarizes the basis on which an In Vitro Diagnostic Device was cleared under a 510(k) submission. OIVD implemented the use of this standardized premarket Decision Summary Template in August 1, 2003. The decision summaries have been continuously posted on the OIVD webpage and the public has full access to them. CDRH has been receiving positive feed back from the regulated industry, the professional community and the consumers because the decision summaries had given them the ability to make informed decisions regarding the use of such In Vitro Diagnostic Devices as “predicates” and diagnostic kits to be used professionally or at home.

FDA Patient Safety News (FDA PSN)

CDRH leads the agency production of FDA Patient Safety News (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm), a monthly television news show distributed to health care practitioners. FDA PSN is a major agency vehicle for communicating safety messages on medical products to physicians, nurses, pharmacists, risk managers and educators across the nation. Now in the third year of production, PSN incorporates stories from CDER, CDRH and CBER on medical errors, patient safety, recalls and alerts, and newly approved drugs, devices and biological products. Since its inception in 2002, FDA PSN has covered over 250 separate stories designed to reduce medical errors and improve the safety of FDA-regulated medical products. This year, FDA PSN received an Award of Excellence from National Association of Government Communicators. The show is broadcast each month on several medical satellite TV networks that bring continuing education for health professionals to over 4,500 U.S. hospitals and long-term care facilities. The show also has its own website (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm), which received about 6,000 visits per month in FY 04, an increase of about 50% since FY 03. On the site, users can view current or past editions of the show, search for individual stories, get more information on any story, email stories to other people, and report problems through MedWatch. This year, users were able to download a video story for later viewing.

Over 2,500 website users have joined a listserve to be automatically notified about the release of each month's show. A FY 04 survey of listserve subscribers indicated that 94 % of respondents used the FDA PSN safety recommendations "frequently" (41 %) or "occasionally" (53 %).

Public Health Notifications

The Public Health Notification (PHN) is one of the tools that CDRH uses to get an important message to the user community about risks associated with use of medical devices. PHN is a source of information for health care practitioners, immediately recognizable as a statement from the FDA about a device risk with information on how to avoid or mitigate the risk. This outreach tool is used when:

  • The Center has information or a message to convey to health care practitioners that they would want to know in order to make informed clinical decisions about the use of a device or device type;
  • The information may not be readily available to the affected target audience in the health care community; and
  • The Center can make recommendations that will help the health care practitioner mitigate or avoid the risk. The recommendations reflect the current thinking of the Center on approaches for the health care practitioner to mitigate the risk associated with the problem.

In FY 04, the Center issued five Notifications as part of its information sharing with health care practitioners. All of the Notifications issued by CDRH can be found at http://www.fda.gov/MedicalDevices/Safety/default.htm.

 Information Technology

Division Tracking System (DTS)

The primary purpose of DTS is to provide ODE and OIVD with a means to track the division level review process. Since the deployment of DTS, Division directors and branch chiefs have been able to track several details pertaining to the review process including the state of the review workflow. There are several reports available at the division, branch and office level that show progress towards MDUFMA goals, employee workload and other useful metrics. There is also a powerful custom report builder feature that allows users to generate their own custom queries on the data. These reports can be saved, printed, exported to PDF or exported to Excel.

During FY 04 the initial version of the Division Tracking System (DTS) was developed and deployed. The DTS development process began with a comprehensive requirements gathering phase during which several prototyping sessions were held with different groups of end users. The first release of DTS was deployed in February 2004. All existing data from the previous tracking system was converted to the new tracking system. During the remainder of the year, additional versions (updates) of the software were released. Version 1.4, the last version to be deployed in FY 04, provided the ability to enter and track Request for Designation (RFDs) for FDA’s Office of Combination Products.


Image2000, the CDRH system for storing electronic copies of device application submissions, was upgraded to provide additional capabilities for ODE and OIVD reviewers. The upgrades allowed users to:

  • store documents in Portable Document Format (PDF), the Agency's standard;
  • perform full text searching, copying or saving of documents; and
  • print all or part of the submission.

In FY 04 CDRH began scanning over 2,200 boxes of past IDE and PMA paper submissions, making the data electronic, searchable and easily retrievable from the reviewer’s desktop.

The Electronic Submissions Pilot was initiated with several manufacturers participating in the pilot program. The pilot allows industry to complete a 510(k) original submission using the CDRH eSubmissions application. CDRH received feedback from industry representatives and plans to roll out the software for production release in FY 06.

A Freedom of Information (FOI) Module was added to the Image2000 system. The modules allowed for on-line redactions for FOI requests of pre-market submissions.

In addition, presentations on electronic submissions and document management were made to the Drug Information Association, AdvaMed, and at the FDA News’s FDA Information Management Summit.

Turbo 510K (eSubmission)

In an effort to standardize the 510(k) submission, reduce premarket review effort and develop a better premarket/post market balance more in line with the TPLC regulatory concept, OIVD continued developing the Turbo 510(k) or eSubmission program. An eSubmission will guide the industry to submit only scientifically and administratively complete applications, making it easier to meet MDUFMA goals. In addition this program preserves institutional memory, enhances knowledge management and increases consistency of decision making regarding product clearances.

In FY 04, significant gains were made in the development of the Turbo 510(k) Stakeholder training provided suggestions for improvement. The Turbo 510(k) will be piloted on a voluntary basis in FY 05.


CDRH continued the development of electronic radiological health submissions (eRad Health) to automate the review, analysis and management of the 19,000 radiological health safety product reports CDRH receives each year. We also initiated efforts to enhance system functionality by migrating over 300,000 records from the existing reporting database into the new database. The eRad Health project will enable CDRH to better monitor industry and the radiation-emitting electronic products by automating preparation, capture, and analysis of electronic product submission data.

Paperless Assignments for BIMO

In FY 04, we implemented a paperless inspection assignment process. The paperless assignment process helps to create over 300 Bioresearch Monitoring inspection assignments annually by electronic means, resulting in substantial cost savings for mail distribution and document storage and enhancing the efficiency of FDA's inspectional process.

 CDRH IT Projects Under Development

In FY 04 CDRH IT continued developing IT tools necessary to carry out our mission, including:

  •  eConsult - Working with representation of all CDRH Offices, a Vision Document was written describing the role and broad expectations of eConsult. This system will coordinate and track consults requested by one Office of another Office.
  •  GMDN - Working across several CDRH Offices, a Vision Document was created for GMDN.
  •  eRoom - Continue using the eRoom as collaborative tool and expanded the pilot to include various Program subjects/studies.
  •  CFR - Enhanced the Code of Federal Regulations database application to include final notices, a feature not available through the Government Printing Office but developed by CDRH and added to the FDA public website.

Industry Assistance

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 U.S. device firms also 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.

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.

CDRH’s small business division ( http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm ) strives 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.

It also serves as the lead within CDRH for the MDUFMA Small Business Determination (SBD), processing 626 SBD requests (570 were granted and 56 were denied) in FY 04.

Other types of assistance provided to small businesses are similar to those that provided 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 CDRH provides to manufacturers involves responding to individual inquiries, questions and concerns. We do this through several mechanisms, including:

  •  Automated Call Center: CDRH maintains a 24 hours per day automated call center, offering 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 30,000 telephone inquiries per year.
  •  E-mail: All of our web pages for manufacturers, and many other CDRH web pages, include access to the small business division email account,  dsmica@CDRH.fda.gov. We respond to over 25,000 email inquiries per year. In addition, we receive and respond to approximately 1,500 written/fax inquiries per year.
  •  510(k) Status Program: We assist manufacturers in determining the status of their pending premarket notification applications (510(k)). Requests for this service have decreased dramatically as CDRH eliminated the backlog of 510(k) applications. However, we still receive approximately 484 requests each year.
  •  Broadcast Fax: CDRH 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 2004, 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: CDRH’s OCER is a warehouse to over 1,000 FDA publications. Although approximately 80% are accessible electronically, our stakeholders still request hardcopies. In FY 2004, approximately 83,000 publications were distributed either by hardcopy or on diskette.
  •  Manufacturers Assistance Website: Our website 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 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm) received 32,000 hits in FY 2004.

Device Advice Webpage

Early on, CDRH recognized both the advantages and the limitations of providing extensive information for manufacturers on our website. Often, just having “access” to information doesn’t make it easy to find a particular document. Further, while a person might find a particular document, he might not be aware of related documents or information. To address these concerns, we designed and implemented Device Advice (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm). This website has been a successful source of information and received 133,000 hits in FY 2004. With Device Advice, industry can determine:

  • whether the product is a radiation-emitting electronic product, a medical device, both a radiation-emitting electronic product and a medical device, or 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 a product.

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).

CDRH device specialists launched the first version of Device Advice in 1998. Since then, it has consistently been one of the ten most used CDRH websites. In FY 2004, we modified topics to include the following information:

 Accredited Persons Inspection Program – new page

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ PostmarketRequirements/ThirdPartyInspection/ucm125410.htm

Workshops /Presentations

During FY 2004, CDRH 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);
  • Regulatory Affairs Professional Society (RAPS);
  • AdvaMed; and
  • Medical Design & Manufacturing (MD&M)