Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations
Published: 2007-01-05T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that sought accreditation, the number that were accredited, and reasons for denial of accreditation and (2) the number of inspections conducted by accredited organizations. It also includes information about factors that could influence manufacturers' interest in voluntarily requesting and paying for an inspection by an accredited organization. GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004--when FDA first cleared an accredited organization to conduct independent inspections--through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers.
section_title: What GAO Found
paragraphs: FDA granted accreditation to 17 of 23 organizations that applied to conduct inspections of establishments where medical devices are manufactured. FDA denied accreditation to applicants that did not meet minimum criteria because their applications were not correctly completed or did not demonstrate the applicants' technical competence. During the first accreditation year, which started in April 2003, FDA received 23 applications. Of the 23 applications, 2 were not correctly completed and 2 did not demonstrate that the applicants had adequate technical competence. Although the remaining 19 applicants met the minimum criteria, MDUFMA limited the number of organizations that could be accredited to 15 during the first year after FDA issued criteria for accreditation. FDA scored the 19 applications against these criteria and rank-ordered them. It accredited the 15 organizations with the highest ranking applications, but 1 organization later withdrew. After the initial accreditation year, FDA received 2 more applications for accreditation and it accredited both organizations. These 16 organizations remained accredited as of October 31, 2006. Between March 11, 2004, and October 31, 2006, two accredited organizations conducted independent inspections--one inspection of a domestic establishment and one inspection of a foreign establishment. During that same period, 36 inspections of domestic establishments and 1 inspection of a foreign establishment were conducted by accredited organizations jointly with FDA officials as part of training that FDA requires of accredited organizations. As of October 31, 2006, individuals from 7 of the 16 accredited organizations had completed all training requirements and were cleared to conduct independent inspections. Several factors may influence manufacturers' interest in voluntarily requesting an inspection by an accredited organization. According to FDA and representatives of affected entities, there are potential incentives and disincentives to requesting an inspection, as well as reasons for deferring participation in the program. Potential incentives include the opportunity to reduce the number of inspections conducted to meet FDA and other countries' requirements and to control the scheduling of the inspection. Potential disincentives include bearing the cost for the inspection and uncertainty about the potential consequences of making a commitment to having an inspection to assess compliance with FDA requirements in the near future. Some manufacturers might be deferring participation. For example, manufacturers that already contract with a specific accredited organization to conduct inspections to meet the requirements of other countries might defer participation until FDA has cleared that organization to conduct independent inspections. The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.

section_title: Letter
paragraphs: The Food and Drug Administration (FDA) is responsible for regulating  medical devices that are marketed in the United States. As part of its  responsibilities, FDA inspects domestic and foreign establishments where  medical devices that are marketed in the United States are manufactured  to assess compliance with FDA’s quality system requirements for ensuring  good manufacturing practices (GMP) and other applicable requirements.  During quality system inspections, FDA investigators examine  manufacturing controls, processes, and records. These inspections are  FDA’s primary means of assuring that the safety and effectiveness of  medical devices are not jeopardized by poor manufacturing practices. FDA  is required, by statute, to inspect certain domestic establishments where  medical devices are manufactured at least once every 2 years. FDA has  not, however, been meeting this requirement. Instead, 5 or 6 years  sometimes pass between FDA inspections at any one establishment. In  addition to FDA inspections, many foreign countries require inspections of  establishments where medical devices are manufactured. As a result,  manufacturers that market their devices internationally may face multiple  inspections of their establishments to assess conformity with quality  system requirements of multiple regulatory authorities. Some foreign  countries have accredited, certified, or otherwise recognized organizations  to conduct inspections.
In 2002, the U.S. House of Representatives Committee on Energy and  Commerce recognized that the growth of the medical device industry,  combined with resource constraints at FDA, had made it difficult for FDA  to meets its obligation to inspect, every 2 years, domestic establishments  where class II and class III medical devices are manufactured. It also  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 one  of these recognized organizations to conduct a single inspection that  would satisfy the requirements of both the FDA and foreign countries.  The Medical Device User Fee and Modernization Act of 2002 (MDUFMA),  enacted in October 2002, included provisions designed to (1) increase the  number of medical device manufacturers’ establishments that are  inspected for compliance with FDA requirements and (2) help  manufacturers who market medical devices in both the United States and  foreign countries meet multiple inspection requirements with fewer  inspections.
Specifically, MDUFMA, as amended by the Medical Devices Technical  Corrections Act, required FDA to accredit persons—which are  organizations—to conduct inspections of certain establishments. In  response, FDA implemented an accredited persons inspection program,  which provides an alternative to a traditional FDA-conducted postmarket  inspection for eligible manufacturers of medical devices who apply to  participate and are willing to pay an accredited organization to conduct  the inspection. (FDA conducts inspections at no cost to the  manufacturer.) Under this program, organizations accredited by FDA may  inspect establishments and submit reports to FDA, which makes the final  determination of compliance with applicable laws and regulations.  MDUFMA specified eligibility criteria for manufacturers to participate in  the program, including that the manufacturer markets, or intends to  market, a medical device in a foreign country, and that the establishment  did not receive warnings for significant deviations from compliance  requirements based on its last inspection. MDUFMA also established  minimum requirements for organizations to be accredited to conduct  inspections through this program, including protecting against financial  conflicts of interest and ensuring the competence of the organization to  conduct inspections. MDUFMA required FDA to issue criteria for  accreditation within 180 days of its enactment, and limited the number of  organizations that FDA could accredit during the first year after issuance  of criteria for accreditation to 15.
MDUFMA requires us to report on several aspects of FDA’s accredited  persons inspection program. This report provides information on the  status of the program, specifically, (1) the number of organizations that  sought accreditation, the number that were accredited, and reasons for  denial of accreditation and (2) the number of inspections conducted by  accredited organizations. This report also provides information about  factors that could influence manufacturers’ interest in voluntarily  participating in FDA’s accredited persons inspection program. In addition,  MDUFMA also requires us to report on the number of inspections  conducted by FDA; this information is included in appendix I. MDUFMA  also requires us to report on other aspects related to the oversight and  effectiveness of the accredited persons inspection program, but data were  too limited for us to provide meaningful information on these aspects of  the program at this time.
To conduct our review, we examined FDA documentation of the number  of applications for accreditation it received and its evaluation of those  applications, and we interviewed FDA officials. We also asked FDA to  provide the number of inspections conducted from March 11, 2004—the  date when FDA first cleared an accredited organization to conduct  independent inspections—through October 31, 2006. We determined that  the data FDA provided were sufficiently reliable for the purposes of this  report. To gain perspective on manufacturers’ interest in participating in  the accredited persons inspection program, we interviewed  representatives of FDA and affected entities—four accredited  organizations, three organizations that represent manufacturers, and six  manufacturers. The information we obtained from this nonscientific  sample of representatives of affected entities can not be generalized to  other accredited organizations or manufacturers. We conducted our work  from February 2006 through November 2006 in accordance with generally  accepted government auditing standards. See appendix II for a more  detailed discussion of our methodology.
subsections: section_title: Background
paragraphs: FDA conducts quality system inspections of medical device  manufacturers’ establishments 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. FDA’s routine postmarket quality system inspections include both  comprehensive and abbreviated inspections, which differ in the scope of  inspectional activity. A comprehensive postmarket inspection of an  establishment assesses multiple aspects of the manufacturer’s quality  system, including management activities to establish, implement, and  review the quality system; procedures to control the design and the  production or processing of the device to ensure that it conforms to  specifications and user requirements; and procedures for preventing,  identifying, and correcting quality problems. Based upon its findings  during inspection, FDA classifies completed inspections into one of three  categories based on the extent to which the establishment deviates from  applicable requirements of the quality system regulation: No action  indicated (which indicates no deviations or only minor deviations),  voluntary action indicated (which indicates minor to significant  deviations), or official action indicated (which indicates significant  deviations and warnings).
MDUFMA required FDA to accredit third persons—which are  organizations—to conduct inspections of certain establishments.
Manufacturers that meet eligibility requirements may request a postmarket  inspection by an FDA-accredited organization.
To be eligible to request an inspection of an establishment by an  accredited organization, a manufacturer must    manufacture a class II or class III medical device;    market at least one of those devices in the United States;    market or intend to market at least one of those devices in a foreign  country and either (a) one of those countries certifies, accredits, or  otherwise recognizes the FDA-accredited organization as authorized to  conduct inspections of establishments or (b) the manufacturer submits a  statement to FDA that the law of one of the countries recognizes an  inspection by FDA or the FDA-accredited organization;   have received, after its most recent inspection, a classification by FDA as  “no action indicated” or “voluntary action indicated” for the establishment  that it seeks to have inspected by an accredited organization; and request and receive FDA’s approval to use a specific accredited  organization.
In addition, to be eligible to request an inspection by an accredited  organization, domestic establishments may not have been inspected by the  accredited organization during the previous four years, unless the  manufacturer requests and receives a waiver from FDA, and foreign  establishments must be periodically inspected by FDA.
Organizations seeking accreditation to conduct inspections through the  accredited persons inspection program submit applications to FDA for  review. FDA established criteria for accreditation that incorporate the  minimum requirements set out in MDUFMA, including the independence  and competence of the accredited organizations. For example, to ensure  the independence of organizations accredited to conduct inspections of  medical device establishments, MDUFMA prohibits accredited  organizations from engaging in the design, manufacture, promotion, or  sale of articles regulated by FDA, and FDA’s criteria include whether the  organization has procedures in place to prevent conflicts of interest. To  ensure that accredited organizations are competent to conduct  inspections, MDUFMA requires that accredited organizations agree to limit  their work to that for which they have sufficient competence and capacity,  and FDA’s criteria include whether the organizations’ personnel have  knowledge of pertinent FDA laws, regulations, and inspection procedures.
FDA developed a scoring procedure to evaluate applications from  organizations in light of these and other criteria.
FDA also developed a training program for inspectors from accredited  organizations that involves both formal classroom training and training  inspections of establishments. The formal classroom training includes  instruction on FDA’s regulations pertaining to medical devices and FDA’s  techniques for conducting quality system inspections. FDA also requires  inspectors to successfully complete three joint inspections with FDA  before being cleared to conduct independent inspections. FDA relies on  manufacturers to volunteer to host these joint inspections. During the first  training inspection, an FDA inspector leads the inspection and the  accredited organization’s inspector acts primarily as an observer. During  the second training inspection, the accredited organization’s inspector  conducts an inspection while being observed and evaluated by an FDA  inspector who may provide assistance to the trainee. During the third  training inspection, the accredited organization’s inspector conducts an  inspection while being observed and evaluated by an FDA inspector who  may not provide assistance to the trainee. Each individual inspector from  an accredited organization must complete all training requirements  successfully before being cleared to conduct independent inspections.
Manufacturers that want to have an inspection through the accredited  persons inspection program submit a request to FDA that identifies the  accredited organization they intend to use and asks for FDA’s approval.  Manufacturers include with that request documentation showing that they  meet the eligibility criteria. FDA can then provide clearance and approve  the request, ask for additional information, or deny the request. If the  request is approved, the manufacturer 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. FDA makes the final assessment of compliance with  applicable requirements.
section_title: FDA Accredited 17 of 23 Organizations and Denied Accreditation When Criteria Were Not Met or Because MDUFMA Limited the Number That Could Be Accredited
paragraphs: FDA granted accreditation to 17 of 23 organizations. FDA denied  accreditation to applicants that did not meet minimum criteria because  their applications were not correctly completed or did not demonstrate  technical competence. In addition, some applicants were denied  accreditation because MDUFMA limited the number of organizations that  could be accredited to 15 during the first year after FDA issued criteria for  accreditation.
FDA granted accreditation to 17 of 23 organizations that applied to  conduct inspections of establishments through the accredited persons  inspection program. One or more foreign governments had already  authorized each of these accredited organizations to conduct inspections  to assess compliance with quality system requirements. FDA announced  accreditation of 15 of 22 applicant organizations on November 6, 2003. One  of these accredited organizations withdrew from the program in December  2003, leaving 14 accredited organizations. After the initial accreditation  year, FDA received two additional applications for accreditation, including  one from an organization that had been denied accreditation during the  first year; FDA accredited both of these organizations. The total number of  accredited organizations as of October 31, 2006, was thus 16.
FDA denied accreditation to applicants that did not meet minimum criteria  because their applications were not correctly completed or did not  demonstrate the applicants’ technical competence and because more  organizations met the minimum criteria for accreditation than FDA could  legally accredit. During the first accreditation year, FDA received a total of  23 applications from 22 organizations. Of these 23 applications, 2 were not  correctly completed and the applicants were denied accreditation. For  example, these applications did not include required documentation  showing the authority, responsibility, and reporting structure of the  individuals who would perform work through the accredited persons  inspection program. One of the organizations that had initially submitted  an application that was not correctly completed submitted a second,  correctly completed application within the first accreditation year. (This  second application is included among the total of 23 applications FDA  received during the first accreditation year.) Thus, FDA received 21  correctly completed applications from 21 organizations during the first  accreditation year.
FDA also denied accreditation to applicants that did not meet minimum  criteria because their applications did not demonstrate that the applicants  had adequate technical competence. To evaluate organizations’  qualifications, FDA developed a checklist for scoring applications against  the criteria for accreditation. A group of FDA staff assessed the  applications and assigned scores to specific elements, such as technical  competence and prevention of conflict of interest. FDA determined that 2  of the 21 correctly completed applications did not demonstrate that the  organization had adequate technical competence, and it denied  accreditation to these 2 organizations.
FDA found that the remaining 19 organizations that applied for  accreditation during the first accreditation year met the minimum criteria  for accreditation, but it was limited to accrediting 15 organizations during  that year. FDA rank-ordered the applications by the total score it assigned  through use of the checklist. FDA granted accreditation to the 15  organizations with the highest ranking applications, and denied  accreditation to the remaining 4 organizations with lower-ranking  applications.
section_title: Two Inspections Independently Conducted by an Accredited Organization
paragraphs: Between March 11, 2004—the date when FDA first cleared an accredited  organization to conduct independent inspections of establishments—and  October 31, 2006, two accredited organizations conducted independent  inspections—one inspection of a domestic establishment and one  inspection of a foreign establishment. During the same time period, 36  inspections of domestic establishments and 1 inspection of a foreign  establishment were conducted by accredited organizations jointly with  FDA officials as part of the training FDA required of accredited  organizations. As shown in table 1, individuals from 7 of 16 accredited  organizations completed all training requirements and were cleared to  conduct independent inspections by October 17, 2006. The remaining 9  accredited organizations had not completed all training requirements as of  October 31, 2006.
To gain perspective on the number of inspections conducted by accredited  organizations, we asked FDA how many inspections it had conducted from  March 11, 2004, through October 31, 2006, that could potentially have been  conducted by accredited organizations. FDA could not provide exact  counts of these inspections for two reasons. First, only those  manufacturers that market, or intend to market, a device in a foreign  country are eligible to be inspected by an accredited organization, but  FDA does not routinely obtain information about foreign marketing  activities or plans. Second, eligibility for an inspection by an accredited  organization is limited to manufacturers of class II or III medical devices,  but FDA does not have readily available information about the  classification of devices that were manufactured at establishments at the  time of inspection. Instead of providing exact counts of the number of  inspections FDA had conducted that could potentially have been  conducted by accredited organizations, FDA told us how many  comprehensive postmarket quality system inspections it had conducted of  establishments where class II or III medical devices were manufactured as  of October 31, 2006, and that met the criteria for an inspection by an  accredited organization other than the criterion that the manufacturer  markets, or intends to market, a medical device in a foreign country. These  counts provide an upper bound estimate of the number of inspections FDA  had conducted that could potentially have been conducted by accredited  organizations. From March 11, 2004, through October 31, 2006, FDA  conducted 229 inspections of domestic establishments and 48 inspections  of foreign establishments.
section_title: Several Factors Could Influence Manufacturers’ Interest in Participating in the Program
paragraphs: According to FDA and representatives of affected entities, several factors  could influence manufacturers’ interest in voluntarily participating in the  accredited persons inspection program, whether by requesting an  inspection or by hosting a training inspection. FDA and representatives of  affected entities described factors that could serve as potential incentives,  disincentives, or reasons to defer making a request for an inspection by an  accredited organization. Additional factors may influence manufacturers’  interest in participating in the program by hosting required training  inspections.
Potential incentives to having an inspection by an accredited organization  include the opportunity to reduce the number of inspections conducted to  meet FDA and other countries’ requirements and to control the scheduling  of the inspection by an accredited organization.
FDA and representatives of affected entities told us that manufacturers  would prefer to reduce the number of inspections they need to undergo by  having a single inspection cover requirements of FDA and other  governments, rather than having separate inspections. One reason for  this preference is that inspections are disruptive to manufacturers. FDA  and representatives of affected entities told us that FDA’s requirements  are similar, but not identical, to the requirements of other countries. As a  result, a single inspection designed to cover multiple requirements would  likely take more time than a single inspection designed to meet any one set  of requirements, but less time than separate inspections. Representatives  of the accredited organizations with whom we spoke stated that they  expect to be able to address multiple inspection requirements in a single  inspection, and the one inspection of a domestic establishment that an  accredited organization completed independently before October 31, 2006,  was a single inspection designed to meet the requirements of FDA, the  European Union, and Canada.
According to FDA and many representatives of affected entities, another  potential incentive to requesting an inspection by an accredited  organization is that manufacturers can work with accredited organizations  to schedule inspections and can schedule them months in advance. In  contrast, FDA generally notifies manufacturers of inspections about a  week in advance. The reasons representatives of affected entities gave for  the preference for scheduling inspections well in advance include that it  enables them to ensure the availability of their quality managers and  minimize disruption to their normal work activities.
FDA and representatives of affected entities told us that the potential  disincentives to having an inspection by an accredited organization  include bearing the cost for the inspection, doubts about whether  accredited organizations can cover multiple requirements in a single  inspection, and uncertainty about the potential consequences of making a  commitment to having an inspection to assess compliance with FDA  requirements in the near future.
Manufacturers pay for inspections that are conducted by accredited  organizations; in contrast, manufacturers are not charged for inspections  conducted by FDA. Manufacturers that already pay for inspections to  meet requirements of foreign countries will likely face a higher cost for an  inspection that also covers FDA requirements because the requirements  are not identical and the inspection will therefore likely take longer. FDA  and representatives of affected entities stated that bearing the cost for the  inspection might be a disincentive to participation in the program, and  some of these representatives suggested that cost could be particularly  important to small manufacturers.
Although a goal of the accredited persons inspection program is to reduce  the total number of inspections for manufacturers that market devices in  the United States and other countries, some representatives of FDA and  manufacturers raised doubts about whether the accredited organizations  could cover multiple requirements in a single inspection. One of them told  us that the accredited organization that inspects its establishments stated  that it would not combine the inspection to assess compliance with FDA  requirements with an inspection to address other requirements, and would  instead conduct two separate inspections. Similarly, some FDA officials  expressed uncertainty about whether all of the accredited organizations  would develop inspection strategies that effectively address multiple  requirements. FDA and Canada are in the process of establishing a pilot  program to assess whether accredited organizations can meet the  requirements of both countries in a single inspection.
In addition, uncertainty about the potential consequences of making a  commitment to having an inspection to assess compliance with FDA  requirements in the near future is a potential disincentive. Manufacturers  who request an inspection by an accredited organization are committing to  an inspection to assess compliance with FDA requirements in the near  future, even though it is possible that FDA would not inspect them in the  next 5 or 6 years—and inspections carry the risk of regulatory action. FDA  and most of the representatives of affected entities with whom we spoke  told us that this commitment to an inspection is a potential disincentive to  participation in the program. For example, one industry representative  questioned why manufacturers would ask for—and pay for—inspections  when the result could be that FDA closes them down. In addition, because  FDA will make the final determination of compliance with its  requirements, some representatives of affected entities suggested that  manufacturers might be uncertain about whether the accredited  organization’s inspection will satisfy FDA, or whether FDA will conduct an  additional inspection after reading the report prepared by the accredited  organization.
Some representatives of affected entities suggested that manufacturers  might defer a decision about whether to request an inspection by an  accredited organization until uncertainties about the potential incentives  and disincentives have been reduced. For example, manufacturers might  defer a decision until there is greater certainty about whether accredited  organizations are able to conduct single inspections to cover multiple sets  of requirements and about how FDA will respond to the inspection reports  prepared by accredited organizations.
According to representatives of affected entities, some manufacturers— those that are already paying to have routine quality system inspections of  their establishments to meet the requirements of other countries—might  have other reasons for deferring a request for an inspection by an  accredited organization. Manufacturers that already contract with a  specific accredited organization to conduct inspections to meet the  requirements of other countries might defer participation until that  organization has completed all required training and been cleared by FDA  to conduct independent inspections. In addition, because manufacturers  want to minimize the disruptiveness of inspections, they might defer  requesting an inspection through FDA’s accredited persons inspection  program until accredited organizations have honed their procedures for  conducting inspections to cover FDA’s requirements.
Manufacturers’ participation in the accredited persons inspection program  also includes their willingness to host training inspections. In addition to  some of the potential incentives and disincentives to requesting an  inspection by an accredited organization, other factors may have  influenced manufacturers’ interest in hosting required training inspections.  Fewer manufacturers have volunteered to host training inspections than  needed for all of the accredited organizations to complete their training.  Some representatives of affected entities speculated that manufacturers  might have believed that training inspections would require more time and  effort for their staff (and would thus be more disruptive) than inspections  conducted by fully trained personnel, or that manufacturers might have  believed that training inspections would be more rigorous than  nontraining inspections if the trainees and FDA personnel were to take  particular care to demonstrate their thoroughness to each other.  Moreover, FDA and representatives of affected entities indicated that  scheduling training inspections was difficult. For example, FDA schedules  inspections a relatively short period of time prior to the actual inspection,  and some accredited organizations were not available to participate  because they had already made prior commitments.
section_title: Agency Comments
paragraphs: We provided a draft of this report to the Department of Health and Human  Services for comment. The department stated that our report provides an  accurate and balanced explanation of the accredited persons inspection  program and provided technical comments, which we incorporated as  appropriate.
We are sending copies of this report to the Secretary of Health and Human  Services and the Commissioner of FDA, appropriate congressional  committees, and other interested parties. We will also make copies  available to others on request. In addition, the report is available at no  charge on the GAO Web site at http://www.gao.gov. If you or your staffs  have questions about this report, please contact me at (202) 512-7119 or  crossem@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this report.  GAO staff who made major contributions to this report are listed in  appendix III.
section_title: Appendix I: Inspections Conducted by the Food and Drug Administration
paragraphs: The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)  requires us to report on the number of inspections of medical device  establishments conducted by the Food and Drug Administration (FDA).  We are reporting the number of postmarket quality system inspections of  domestic establishments where medium or high risk medical devices  (referred to as class II or class III medical devices) are manufactured and  the number of inspections of foreign medical device establishments  conducted by FDA.
To provide this information, we asked FDA how many inspections it  conducted from March 11, 2004—the date when FDA first cleared an  accredited organization to conduct independent inspections—through  October 31, 2006. With regard to domestic establishments, we asked for  the number of quality system inspections of establishments where class II  or class III medical devices are manufactured. FDA provided us with the  number of such inspections based on the classification of medical devices  as of October 31, 2006, because FDA does not have readily available  information about the classification of devices manufactured at the  establishments at the time of inspection. FDA updates the information  about device classification in its inspection database when the types of  medical devices an establishment handles changes, for example, when a  manufacturer changes its device inventory or when FDA reclassifies a  device. Based on our review of FDA documents and discussions with FDA  officials, we determined that the data FDA provided were sufficiently  reliable for the purposes of this report.
FDA reported that from March 11, 2004, through October 31, 2006, it  conducted 2,814 postmarket quality system inspections of domestic  establishments where a class II or III medical device was manufactured as  of October 31, 2006. These establishments included medical device  manufacturers and remanufacturers, packers and repackers, labelers and  relabelers, contract sterilizers, software manufacturers, and reprocessors.  During this time period, another 86 domestic inspections were conducted  by state investigators under contract to FDA. FDA also reported that it  conducted 656 inspections of foreign medical device establishments from  March 11, 2004, through October 31, 2006.
section_title: Appendix II: Scope and Methodology
paragraphs: To determine the number of organizations that sought accreditation, the  number that were accredited, and reasons for denial of accreditation, we  reviewed FDA documentation of the number of applications for  accreditation it received and its evaluation of those applications, and we  interviewed FDA officials.
To determine the number of inspections of foreign and domestic  establishments conducted by accredited persons, we asked FDA to  provide counts of the number of inspections conducted from March 11,  2004—the date when FDA first cleared an accredited organization to  conduct independent inspections—through October 31, 2006. Based on  our review of FDA documents and discussions with FDA officials, we  determined that the data were sufficiently reliable for our purposes.
To determine whether there are factors that could influence  manufacturers’ interest in voluntarily participating in FDA’s accredited  persons inspection program, we interviewed FDA officials and  representatives of affected entities. As indicated in table 2, the affected  entities with which we conducted interviews were four accredited  organizations, three organizations that represent medical device  manufacturers, and six global medical device manufacturers. For our  sample of accredited organizations, we selected two that had been cleared  by FDA to conduct independent inspections as of April 2006 and two that  had not. To select our sample of manufacturers, we asked the  representatives of each of the three organizations that represent  manufacturers to provide us with a list of five manufacturers. Two of the  organizations provided lists of five manufactures and one organization  provided a list of four manufacturers. We randomly selected two global  manufacturers from each list. The information we obtained from these  representatives of affected entities can not be generalized to other  manufacturers or accredited organizations.
We also reviewed applicable law, regulations, legislative history, FDA  guidance, and other relevant documents. We conducted our work from  February 2006 through November 2006 in accordance with generally  accepted government auditing standards.
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: In addition to the contact named above, James McClyde, Assistant  Director; Kristen Joan Anderson; Cathleen J. Hamann; and Julian Klazkin  made key contributions to this report.