Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
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3 Premarket Notification
3 Premarket Notification
Pages 7-16
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or premarket notification process, explaining the concept of substantial equivalence and discussing the scientific integrity of the process, its strengths, its weaknesses, and its flexibilities.1 Coauthor Philip J Phillips, of the Phillips Consulting Group and formerly the deputy director for science and regulatory policy at CDRH, presented an overview of the paper that he drafted in collaboration with Larry Kessler, of the University of Washington School of Public Health, who previously served as director of the CDRH Office of Science and Engineering Laboratories and director of the CDRH Office of Surveillance and Biometrics.
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A new industry that has emerged in the United States reprocesses single-use disposable devices and reintroduces them into interstate commerce as new, and these are subject to the same FDA regulatory review processes as the original devices. Similarly, there is an industry that remanufactures durable medical equipment, including some class III medical devices, and reintroduces them into interstate commerce.
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If a new device is put into class I in accordance with an existing regulation, the general controls applicable to that generic type of device ensure its safety and effectiveness. If a device is put into class II, the general controls and the applicable special controls that have been developed ensure the product's safety and effectiveness.
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In that case, a cardiovascular mapping catheter that is used for diagnosis is a class II medical device, but the same product promoted and labeled for therapeutic purposes is a class III device subject to PMA requirements. The other is a change from general to specific indications for use and vice versa.
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submission always contains data, Phillips said. The manufacturer of a product that has the same intended use and the same technologic characteristics as a predicate device must submit descriptive data, including side-by-side comparisons of the new device and the legally marketed device with which it is compared, and performance data when descriptive data do not ensure performance.
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Some may consider that having outside reviewers do FDA's work poses a vulnerability but, Phillips said, the work product comes to the agency for final review of a submission. Premarket Notification vs Premarket Approval Phillips stressed that the premarket notification, or 510(k)
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From concept to obsolescence, class III medical devices are subject to FDA conditions and requirements that their manufacturers are obliged to meet. These devices do receive approval by FDA.
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ORA manages import operations at the points of importation by interacting with US Customs and Border Protection, evaluating entries to determine whether they are legally able to enter the marketplace in the United States. ORA also coordinates overall FDA compliance and enforcement policy and has a criminal-investigations group that evaluates possible felonies and misdemeanor criminal cases.
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It also develops strategies for inspections and inspection assignments, coordinates foreign assignments, reviews inspections and enforcement cases, and enforces promotion and advertising law. The Office of Chief Counsel (OCC)
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FDA is trying to prevent problems, not only to react to them, and to identify issues related to risk as they emerge and deal with them strategically in a coordinated effort, not only with compliance activities but with educational efforts. Nevertheless, much time is spent in reacting to issues that come to light.
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