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See Related InformationCDRH Specific Questions
Stakeholders Meeting, August 18, 1998

Please note: Section 406(b) of the FDA Modernization Act of 1997 (FDAMA) amended section 903 of the Federal Food, Drug, and Cosmetic Act (FFD&C act). Therefore, the following questions are directed at CDRH medical device and radiation-emitting product programs covered by the FFD&C act. We are not including questions about a third major component of CDRH’s program activities, implementation of the Mammography Quality Assurance Standards Act of 1992, because the mammography program is conducted under authorities contained in the Public Health Service Act. Section 406(b) of FDAMA does not apply to the Public Health Service Act.

  1. Device Information: CDRH is an authoritative and independent source of information on medical devices and radiation-emitting products through a variety of media. Under the FFD&C act, the agency has responsibility to make its information available to manufacturers, patients and others under subject to privacy protection and Freedom of Information Act redaction. The sources of information include CDRH’s home page and Device Advice system on the world-wide-web, video teleconferences, Facts on Demand system (fax-based), DSMA 800 number, and telephone Help Desk. In addition, FDAMA directed FDA to establish and maintain information systems to track applications. Currently, there is no Congressional appropriation to fund this system. How can we assure that the device industry, health professionals, and consumers get the information that they need? Have you accessed information from CDRH via any of the above sources? Were you able to get information to address your needs?

  2. Laboratories/Science base: As a science-based, consumer protection agency, FDA uses its laboratories to both generate and provide data that are unbiased and of high quality in support of standards and guidance documents. It is also important that the agency employ an expert cadre of laboratory review scientists who support product approval activities with up-to-date scientific understanding of the product based upon their participation in current research in the field. With the increasing use of innovations such as microprocessor control, artificial intelligence, miniaturization, remote operation, medical devices are increasingly complex. Keeping current with the diverse and sophisticated scientific disciplines used in the design and manufacture of existing and proposed medical devices is a great challenge to the agency’s resources. What is the most efficient way for the agency to meet this challenge?

  3. Radiation Programs: The agency is directed by statute to maintain inspection and testing capacity and to promulgate standards that will reduce unnecessary radiation exposure to the U.S. public from radiation-emitting devices. Radiation exposure can result from both medical and consumer products. Examples of medical products include mammography x-ray units, diagnostic ultrasound machines, and medical lasers. Examples of consumer products include television sets and monitors, microwave ovens, tanning booths, and sun lamps. CDRH activity in the radiation area has been reduced by 80% over the last ten years. How can we appropriately assure that the public is safe from radiation-emitting products?

  4. Premarket Approvals: What needs to be done to reconcile CDRH premarket approval activities with statutory directives? Should the agency be making increased investments in developing additional national or international standards, or are existing standards sufficient? Are there additional voluntary standards that, if recognized, would increase efficiencies? What is the proper role of external review, for example, the U.S. Third Party Review Program or the U.S. and European Union Conformance Assessment Bodies (CABS)? How can the agency meet the explicit time directives listed in the statute and what performance level should constitute accomplishment of these directives?

  5. Postmarket Surveillance and Adverse Event Reporting: Adverse events associated with medical devices provide signals of potential problems that need addressing. FDA’s system for monitoring and evaluating adverse events has been the Medical Device Reporting (MDR) system. As an alternative to the user reporting component of the MDR system, FDA has been directed to design a "sentinel" reporting system based upon a sample of hospitals and other medical facilities. This system would ideally complement the manufacturer reporting aspect of MDR. Currently, there is no Congressional appropriation to fund the Sentinel system. What suggestions do you have for implementing the Sentinel program?

  6. Postmarket Surveillance Studies: The Postmarket Surveillance Studies Program has produced few completed studies. FDAMA removed the Required Postmarket Surveillance program and assigned FDA the option to call for Postmarket Surveillance for certain relatively high risk products, when needed. How can the agency make the revised postmarket surveillance studies program work effectively?

  7. Establishment Registration, Device Listing Database: This database is a key component of CDRH’s postmarket surveillance/compliance. Today, the agency does not have a comprehensive and current database. How might this program be structured to achieve this goal?

  8. Inspections: CDRH’s inspection program is designed to ensure that medical devices and radiation-emitting products are designed, manufactured and distributed in compliance with Good Manufacturing Practices, Quality Systems Regulations, and other standards. In addition to inspections for specific purposes, such as "for cause" and bioresearch monitoring inspections, the agency is required to inspect the manufacturers of Class II and Class III devices biennially. Currently, the agency is conducting fewer than half of the device inspections required by statute, with even lower coverage overseas. How can the program be structured to fulfill all inspection requirements?

Return to CDRH Stakeholder Information

Updated 8/7/1998

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