United States Medical Device Regulatory Framework

Abstract

Islands, American Samoa, and other US territories. The medical device industry is a highly regulated segment of the US economy. A report, Medical Device Industry Assessment, Updated March 24, 2010, (International Trade Administration, US Department of Commerce), [http://ita.doc.gov/td/health/medical.html] points to the United States as the leader in the manufacturing of medical devices and the largest medical devices market in the world. It is roughly 42% of the world’s total, with an estimated value at more than US$100 billion in 2008. The report also noted that over the past decade, the value of exported and imported medical devices steadily increased. Shown in Table 20.1 is the medical device sector trade flow in 2007 and 2008 based on the North American Industry Classification System (NAICS) code. Table 20.1 Medical device sector trade flows by NAICS code in billions of US dollars NAICS code Descriptionoverview of the US regulatory framework, as well as to introduce the general regulatory requirements, premarket and postmarket, necessary to legally market medical devices in the United States. Since the majority of device submissions are classified in Class I and Class II, there is more effort to clarify the premarket notification 510(k) clearance process and the general regulatory controls mandatory to all classes (I, II, and III). 20.2 The FDA Center for Devices andRadiological HealthIn the United States, the FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices and radiation-emitting products (medical and non-medical). Within CDRH, the Division of Mammography Quality and Radiation Programs ensures that a mammography facility must meet the Mammography Quality Standards Act (MQSA) certification in providing quality mammography services, and are inspected. The USFDA CDRH evaluates new medical devices for safety and effectiveness before they are marketed; and monitors products already on the market, so that unsafe and ineffective products are kept out of the market. In addition, the USFDA CDRH regulates companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States. To learn more about the Center’s mission, vision, and shared values as well as strategic planning, transparency, and innovation initiatives, the following Web site provides comprehensive information: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedical ProductsandTobacco/CDRH/ucm300639.htm 20.3 Total Product Life Cycle ApproachCDRH’s regulatory paradigm in managing medical devices is based on risk. That is, the higher the risk of harm to humans, the greater the level of regulatory control. Further, the integrated systematic approach of Total Product Life Cycle (TPLC) is applied in the regulatory oversight of medical devices. Figure 20.1 is aschematic representation of CDRH’s Total Product Life Cycle (TPLC) model, a “cradle to grave” concept. It depicts the interconnection of the continuing stages throughout the different lifecycle phases; beginning from the initial design concept, prototype, premarket testing, clinical study, manufacturing, marketing, to widespread use, and finally to obsolescence of the “old” technology. An attribute of TPLC is the required interaction among stakeholders. The sharing of important information on device experience and lessons learned from a product’s life cycle are applied to the development of the next phase, and ultimately in the design of the next generation or future products.