FDA is responsible for overseeing the safety and effectiveness of medical devices that are marketed in the United States, whether manufactured in domestic or foreign establishments. All establishments that manufacture medical devices for marketing in the United States must register with FDA. As part of its efforts to ensure the safety, effectiveness, and quality of medical devices, FDA is responsible for inspecting certain domestic and foreign establishments to ensure that they meet manufacturing standards established in FDA’s quality system regulation. FDA does not have authority to require foreign establishments to allow the agency to inspect their facilities. However, FDA has the authority to prevent the importation of products manufactured at establishments that refuse to allow an FDA inspection. Unlike food, for which FDA primarily relies on inspections at the border, physical inspection of manufacturing establishments is a critical mechanism in FDA’s process to ensure that medical devices and drugs are safe and effective and that manufacturers adhere to good manufacturing practices. Within FDA, CDRH assures the safety and effectiveness of medical devices. Among other things, CDRH works with ORA, which conducts inspections of both domestic and foreign establishments to ensure that devices are produced in conformance with federal statutes and regulations, including the quality system regulation. FDA may conduct inspections before and after medical devices are approved or otherwise cleared to be marketed in the United States. Premarket inspections are conducted before FDA will approve U.S. marketing of a new medical device that is not substantially equivalent to one that is already on the market. Premarket inspections primarily assess manufacturing facilities, methods, and controls and may verify pertinent records. Postmarket inspections are conducted after a medical device has been approved or otherwise cleared to be marketed in the United States and include several types of inspections: (1) Quality system inspections are conducted to assess compliance with applicable FDA regulations, including the quality system regulation to ensure good manufacturing practices and the regulation requiring reporting of adverse events. These inspections may be comprehensive or abbreviated, which differ in the scope of inspectional activity. Comprehensive postmarket inspections assess multiple aspects of the manufacturer’s quality system, including management controls, design controls, corrective and preventative actions, and production and process controls. Abbreviated postmarket inspections assess only some of these aspects, but always assess corrective and preventative actions. (2) For-cause and compliance follow- up inspections are initiated in response to specific information that raises questions or problems associated with a particular establishment. (3) Postmarket audit inspections are conducted within 8 to 12 months of a premarket application’s approval to examine any changes in the design, manufacturing process, or quality assurance systems. FDA determines which establishments to inspect using a risk-based strategy. High priority inspections include premarket approval inspections for class III devices, for-cause inspections, inspections of establishments that have had a high frequency of device recalls, and other devices and manufacturers FDA considers high risk. The establishment’s inspection history may also be considered. A provision in FDAAA may assist FDA in making decisions about which establishments to inspect because it authorizes the agency to accept voluntary submissions of audit reports addressing manufacturers’ conformance with internationally established standards for the purpose of setting risk-based inspectional priorities. FDA’s programs for domestic and foreign inspections by accredited third parties provide an alternative to the traditional FDA-conducted comprehensive postmarket quality system inspection for eligible manufacturers of class II and III medical devices. MDUFMA required FDA to accredit third persons—which are organizations—to conduct inspections of certain establishments. In describing this requirement, the House of Representatives Committee on Energy and Commerce noted that some manufacturers have faced an increase in the number of inspections required by foreign countries, and that the number of inspections could be reduced if the manufacturers could contract with a third-party organization to conduct a single inspection that would satisfy the requirements of both FDA and foreign countries. Manufacturers that meet eligibility requirements may request a postmarket inspection by an FDA-accredited organization. The eligibility criteria for requesting an inspection of an establishment by an accredited organization include that the manufacturer markets (or intends to market) a medical device in a foreign country and the establishment to be inspected must not have received warnings for significant deviations from compliance requirements on its last inspection. MDUFMA also established minimum requirements for organizations to be accredited to conduct third-party inspections, including protecting against financial conflicts of interest and ensuring the competence of the organization to conduct inspections. FDA developed a training program for inspectors from accredited organizations that involves both formal classroom training and completion of three joint training inspections with FDA. Each individual inspector from an accredited organization must complete all training requirements successfully before being cleared to conduct independent inspections. FDA relies on manufacturers to volunteer to host these joint inspections, which count as FDA postmarket quality system inspections. A manufacturer that is cleared to have an inspection by an accredited third party enters an agreement with the approved accredited organization and schedules an inspection. Once the accredited organization completes its inspection, it prepares a report and submits it to FDA, which makes the final assessment of compliance with applicable requirements. FDAAA added a requirement that accredited organizations notify FDA of any withdrawal, suspension, restriction, or expiration of certificate of conformance with quality systems standards (such as those established by the International Organization for Standardization) for establishments they inspected for FDA. In addition to the Accredited Persons Inspection Program, FDA has a second program for accredited third-party inspections of medical device establishments. On September 7, 2006, FDA and Health Canada announced the establishment of PMAP. This pilot program was designed to allow qualified third-party organizations to perform a single inspection that would meet the regulatory requirements of both the United States and Canada. The third-party organizations eligible to conduct inspections through PMAP are those that FDA accredited for its Accredited Persons Inspection Program (and that completed all required training for that program) and that are also authorized to conduct inspections of medical device establishments for Health Canada. To be eligible to have a third- party inspection through PMAP, manufacturers must meet all criteria established for the Accredited Persons Inspection Program. As with the Accredited Persons Inspection Program, manufacturers must apply to participate and be willing to pay an accredited organization to conduct the inspection. FDA relies on multiple databases to manage its program for inspecting medical device manufacturing establishments. DRLS contains information on domestic and foreign medical device establishments that have registered with FDA. Establishments that are involved in the manufacture of medical devices intended for commercial distribution in the United States are required to register annually with FDA. These establishments provide information to FDA, such as establishment name and address and the medical devices they manufacture. As of October 1, 2007, establishments are required to register electronically through FDA’s Unified Registration and Listing System and certain medical device establishments pay an annual establishment registration fee, which in fiscal year 2008 is $1,706. OASIS contains information on medical devices and other FDA-regulated products imported into the United States, including information on the establishment that manufactured the medical device. The information in OASIS is automatically generated from data managed by U.S. Customs and Border Protection, which are originally entered by customs brokers based on the information available from the importer. FACTS contains information on FDA’s inspections, including those of domestic and foreign medical device establishments. FDA investigators enter information into FACTS following completion of an inspection. According to FDA data, more than 23,600 establishments that manufacture medical devices were registered as of September 2007, of which 10,600 reported that they manufacture class II or III medical devices. More than half—about 5,600—of these establishments were located in the United States. As of September 2007, there were more registered establishments in China and Germany reporting that they manufacture class II or III medical devices than in any other foreign countries. Canada, Taiwan, and the United Kingdom also had a large number of registered establishments. (See fig. 1.) Registered foreign establishments reported that they manufacture a variety of class II and III medical devices for the U.S. market. For example, common class III medical devices included coronary stents, pacemakers, and contact lenses. FDA has not met the statutory requirement to inspect domestic establishments manufacturing class II or III medical devices every 2 years. The agency conducted relatively few inspections of foreign establishments. The databases that provide FDA with data about the number of foreign establishments manufacturing medical devices for the U.S. market contain inaccuracies. In addition, inspections of foreign medical device manufacturing establishments pose unique challenges to FDA—both in human resources and logistics. From fiscal year 2002 through fiscal year 2007, FDA primarily inspected establishments located in the United States, where more than half of the 10,600 registered establishments that reported manufacturing class II or III medical devices are located. In contrast, FDA inspected relatively few foreign medical device establishments. During this period, FDA conducted an average of 1,494 domestic and 247 foreign establishment inspections each year. This suggests that each year FDA inspects about 27 percent of registered domestic establishments that reported manufacturing class II or class III medical devices and about 5 percent of such foreign establishments. The inspected establishments were in the United States and 44 foreign countries. Of the foreign inspections, more than two-thirds were in 10 countries. Most of the countries with the highest number of inspections were also among those with the largest number of registered establishments that reported manufacturing class II or III medical devices. The lowest rate of inspections in these 10 countries was in China, where 64 inspections were conducted in this 6-year period and almost 700 establishments were registered. (See table 1.) Despite its focus on domestic inspections, FDA has not met the statutory requirement to inspect domestic establishments manufacturing class II or III medical devices every 2 years. For domestic establishments, FDA officials estimated that, on average, the agency inspects class II manufacturers every 5 years and class III manufacturers every 3 years. For foreign establishments—for which there is no comparable inspection requirement—FDA officials estimated that the agency inspects class II manufacturers every 27 years and class III manufacturers every 6 years.