Safe Medical Devices for Children (2006) / Chapter Skim
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3 Regulatory Framework for Postmarket Surveillance of Medical Devices
3 Regulatory Framework for Postmarket Surveillance of Medical Devices
Pages 73-111
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From page 73... ...
In this legislation, Congress provided for additional regulatory scrutiny of medical devices while creating a regulatory framework that recognized certain differences between drugs and devices, particularly the substantial variability in the risk posed by different types of devices. Virtually the entire regulatory framework for medical devices is general, that is, it applies to devices whether their primary or exclusive use is with adults or children.
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From page 74... ...
The chapter begins with a brief overview of organizational responsibilities for medical device regulation. It then reviews the premarket regulatory responsibilities of FDA as context for the following description of the agency's responsibilities for postmarket surveillance of medical devices.2 The last section describes some agency programs and activities, for example, inspections of manufacturers that cover both premarket and postmarket arenas.
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From page 75... ...
(Budget Authority plus User Fees) 1994 $159 $159 1995 157 170 1996 144 152 1997 147 160 1998 144 156 1999 147 159 2000 158 170 2001 173 186 2002 180 194 2003 193 217 2004 191 222 NOTE: Program level funding includes user fees from inspections of mammography facilities and, beginning FY 2003, fees provided for under the Medical Device User Fee and Modernization Act of 2002.
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From page 76... ...
In some cases, requirements are established before or at the time of marketing approval for actions that will take place after marketing, for example, when further clinical studies are specified as a condition of FDA's approval of a device. When Clearance or Approval of a Device Is Required According to FDA, approximately 20,000 American and foreign firms produce about 80,000 brands and models of medical devices for the U.S.
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From page 77... ...
) , this class covers · devices for which certain "general" controls (e.g., standards for good manufacturing practices)
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From page 78... ...
. FDA also has the authority to require further studies for devices that are covered by regulations authorizing postmarket surveillance studies as discussed below.
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From page 79... ...
, which was provided for by the 1976 Medical Device Amendments but not implemented until the 1990s (FDA, 1999e)
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From page 80... ...
. To comply with the FDA Modernization Act of 1997 (P.L.
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From page 81... ...
The sponsor must, however, comply with certain recordkeeping and reporting requirements. In addition, even if an IDE is not required, research involving human participants is still subject to certain other requirements, including IRB review (see, e.g., FDA, 2003d)
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From page 82... ...
ll reasonable measures should be used to reduce review times and render regulatory decisions within statutory timeframes." (All text quoted from FDA, 2002q.) User Fees In the Medical Device User Fee and Modernization Act of 2002 (P.L.
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From page 83... ...
. When General or Special Controls Apply General controls apply to all three classes of medical devices (FDA, 1998d)
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From page 84... ...
are not medical devices (21 CFR 10101050) .9 The only standard for a medical 9In 1995, FDA issued a proposed rule to establish a mandatory performance standard for apnea monitors, but the agency withdrew the rule in 2000 (FDA, 2000d)
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From page 85... ...
Some surveillance activities such as adverse event reporting cover all classes of medical devices whereas others, notably required postmarket surveillance studies, are restricted to a small subset of devices.
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From page 86... ...
Chapter 4 returns to this issue. Mandatory and Voluntary Adverse Event Reporting The Federal Food, Drug, and Cosmetic Act authorizes FDA to establish a system for the reporting of adverse events associated with legally marketed medical devices (21 USC 360i)
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From page 87... ...
for device manufacturers and importers.10 The implementing regulations became effective in 1984.11 The Safe Medical Devices Act of 1990 expanded reporting obligations to cover hospitals and other "user facilities" and device distributors. The Medical Device Amendments of 1992 (P.L.
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From page 88... ...
Those who supply medical equipment to patient's homes are considered to be distributors. Box 3.2 summarizes adverse event reporting requirements for medical
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From page 89... ...
Caused or contributed When a death or serious injury was or might have been attributed to a med ical device or when a medical device was or might have been a factor in a death or serious injury, including events that result from (1) failure, (2)
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From page 90... ...
submit certain follow-up or summary reports to FDA. In contrast to the provisions for adverse drug event reporting, the reporting requirements for medical devices do not distinguish between expected (e.g., listed in a drug's labeling)
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From page 91... ...
User facilities must report deaths to both FDA and the manufacturer but need to report serious injuries to FDA only if they do not know the manufacturer of the device. Unlike manufacturers, facilities are not required to report device malfunctions unless they actually cause death or serious injury.
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From page 92... ...
. Alternative Summary Reporting for Manufacturers Although required reporting is not limited to unexpected adverse events involving medical devices, FDA is most interested in the detection of unexpected, serious problems or recognized problems that are occurring more frequently than expected (e.g., given the data from clinical studies on which marketing approval was based)
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From page 93... ...
Before information from adverse event reports is made available to the public, FDA deletes · information involving trade secrets or confidential commercial or financial data; · personal medical or other information (including the serial number of implanted devices) that could identify individual patients or family members; and · identifying information about consumers or health care workers who submit a voluntary report.
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From page 94... ...
Pilot Program for Adverse Event Reporting: MedSun As discussed in Chapter 4, passive surveillance systems have a number of limitations as means of monitoring the safety of medical devices after they have reached the market. Limitations in user facility reporting have been a particular concern.
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From page 95... ...
. As originally provided for in the Safe Medical Devices Act of 1990, such surveillance was required for devices introduced into interstate commerce after January 1, 1991, that were (1)
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From page 96... ...
Medical Device Tracking The tracking of medical devices is intended to assist the prompt notification of users when a device presents a serious, immediate risk to health and to speed the recall of such a device when appropriate. The Safe Medical Devices Act of 1990 required that certain medical devices (those with the same characteristics as those for which the legislation required postmarket surveillance studies)
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From page 97... ...
. The broader problem of MRI magnetization of nearby metal items, including certain implanted medical devices, has been recognized by FDA, clinicians, and manufacturers for many years (FDA, 2001k)
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From page 98... ...
. FDA has the statutory authority to order a recall of a medical device under very restricted circumstances -- only after a finding that there is a reasonable probability that a device "would cause serious, adverse health consequences or death" and when certain other conditions are met (e.g., a company refuses to recall a product voluntarily following an agency request (21 CFR 810.10)
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From page 99... ...
Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, May 13, 2005)
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From page 100... ...
Information included in a Public Health Notification may be disseminated to user facilities, health professionals, health educators, and consumers in various ways designed to fit the topic and the audiences. Methods include letters, e-mail notifications, items in FDA electronic newsletters, posting on various FDA webpages, press releases, articles and other communications in professional journals, and conference and other presentations.
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From page 101... ...
. The agency has recognized that the use of sophisticated medical devices in the home, while an accepted and necessary part of modern health care, "adds an additional level of risk of unintended adverse events" (Arcarese, 2002a, unpaged)
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From page 102... ...
, the Freedom of Information Act (5 USC 552) , and the Trade Secrets Act (18 USC 1905)
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From page 103... ...
Interim and final reports of postmarket surveillance studies or data are treated similarly, although limited findings may be made public in connection with a safety advisory, the approval of a new indication for a product's use, a labeling change, or similar action. Data and information relating to postmarket studies conducted under an IDE would be protected consistent with the IDE confidentiality regulations.
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From page 104... ...
a protocol for a test or study "unless the protocol is shown to constitute trade secret or confidential commercial or financial information" protected under the Freedom of Information Act and implementing regulations; (3) adverse reaction reports, consumer complaints, and similar data and information -- but only after deleting trade secret or confidential commercial or financial information and deleting personnel, medical, and similar information the disclosure of which would constitute an unwarranted invasion of personal privacy; (4)
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From page 105... ...
. Sometimes other statutes may affect the confidentiality protections usually afforded to confidential commercial or financial information under the Federal Food, Drug, and Cosmetic Act and the Freedom of Information Act.
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From page 106... ...
Aggregate results of a safety and effectiveness study may be disclosed in summary form, but raw data or site-specific data are often protected as confidential, unless published in a scientific journal. As applied in the context of postmarket surveillance, FDA would be required by the three statutes discussed above to protect from public disclosure information that constitutes trade secrets or confidential commercial information.
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From page 107... ...
. Such analysis can be applied to adverse events involving medical devices and potential means to prevent them.
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From page 108... ...
Appendix Appendix 1: The Quality Systems Regulation Appendix 2: Application of the Medical Device GMPs [Good Manufactur ing Practice] to Computerized Devices and Manufacturing Processes SOURCE: FDA, 1999c.
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From page 109... ...
Design controls involve · creating plans that cover design and development activities and assign responsibility for implementing them; · specifying design input requirements, that is, the physical and performance requirements for a device design that are appropriate given the device's intended uses and users; · developing the design output, meaning the results of the design effort at each stage, including the finished design effort (the device, its packaging and labeling, and the device master record) ; · verifying that the design output is consistent with the design input requirements; · conducting periodic design reviews to assess the adequacy of the design requirements, evaluate whether the design will meet the requirements, and identify problems; · validating through tests of production units under actual or simulated conditions and other means that the device (including software)
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From page 110... ...
FDA staff would focus on firms with a record of compliance problems and manufacturers of high-risk products, including implants and life-supporting or sustaining devices. International Efforts to Harmonize Policies Medical device development, research, and sales are international in scope.
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From page 111... ...
In the 1990s, the Global Harmonization Task Force (GHTF) was created specifically as a voluntary process to pursue harmonization of national policies on the regulation of medical devices.
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