This time the focal point was medical devices, not pharmaceuticals. But the considerable shortcomings in the FDA's inspection programme for devices were highlighted by the Government Accountability Office (GAO), the same body that last November issued a damning report on the agency's record of inspecting foreign drug manufacturing plants.

The latest report was delivered by Marcia Crosse, director, healthcare at the GAO, as testimony before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.

The occasion was a hearing entitled "Science and Mission at Risk: FDA's Self-Assessment", at which witnesses including FDA Commissioner Dr Andrew von Eschenbach spoke of critically overstretched resources as well as grave operational and scientific deficiencies at what Congressman John Dingell, chairman of the Committee on Energy and Commerce, described as an agency "that is struggling to keep the nation's food and drug supply safe and effective".

Specifically, Cross said the FDA was not meeting its statutory requirement to inspect domestic establishments manufacturing class II (medium risk - e.g., hearing aids) and class III (high risk - e.g., pacemakers) medical devices every two years. Instead, officials from the FDA's Center for Devices and Radiological Health and its Office of Regulatory Affairs interviewed for the GAO review estimated that these inspections occurred every three years (class III devices) or every five years (class II).

Most of the manufacturers inspected by the FDA are in the US, where more than half the 10,600 establishments registered as manufacturing class II or III medical devices are located. Between fiscal year 2002 and fiscal year 2007, the GAO found, the FDA conducted an average of 1,494 and 247 foreign establishment inspections each year, suggesting that the FDA annually inspects around 27 per cent of registered US establishments that have reported manufacturing class II or III medical devices, and around 5 per cent of the corresponding foreign establishments.

More than two-thirds of the foreign inspections were in 10 countries, and the lowest rate of inspections among these countries was for China - nearly 700 establishments registered and only 64 inspections conducted in the six-year period covered by the review.

The FDA does not have the authority to tell foreign establishments they must let the agency inspect their facilities. The agency can, however, prevent the importation of products manufactured at establishments that refuse to let the agency inspect them.

Nonetheless, FDA officials interviewed by the GAO estimated that the agency inspects foreign manufacturers of class II medical devices once every 27 years and class III manufacturers every six years. The GAO also identified "challenges" faced by the FDA in managing its foreign medical device inspection programme.

For example, two databases providing the agency with information about foreign medical device establishments and the products they manufacture "contain inaccuracies that create divergent estimates of establishments subject to FDA inspection", the GAO said, adding: "Despite the divergent estimates, FDA does not routinely verify these data".

And although comparing information from the two databases could help the FDA to determine the number of foreign establishments marketing medical devices in the US, the databases cannot exchange information and any comparisons have to be made manually, the Office noted.

The report highlighted other obstacles to foreign inspections of medical device manufacturers, such as difficulties in recruiting investigators who would travel voluntarily to certain countries and in extending trips if problems were identified during the inspections.

Another source of concern was the low number of inspections conducted through two accredited third-party inspection programmes designed to help both the FDA discharge its statutory duties and medical device manufacturers to meet the agency's requirements and those of other, non-US regulatory authorities in a single inspection.

Under the Accredited Persons inspection programme implemented in response to provisions in the Medical Device User Fee and Modernization Act of 2002, only five inspections were conducted independently by accredited organisations (two domestic, two foreign) between 11 March 2004 - the date when the FDA first cleared an accredited organization to conduct inspections - and 11 January 2008, the GAO found.

As of the same date, only two inspections (both domestic) had been conducted by accredited organisations under the Pilot Multi-purpose Audit Program (PMAP), established in September 2006 by the FDA and Health Canada.

The meagre tally of inspections completed to date under these programmes "raises questions about the practicality and effectiveness of establishing similar programmes that rely on third parties to quickly help FDA fulfil its responsibilities", the GAO commented.

AdvaMed, the US association representing medical device and diagnostics companies, issued a statement saying the FDA "has long been considered the world's standard bearer for safety, but critical steps must be taken to ensure that continues in this period of limited resources and additional responsibilities".

Noting the association's membership of advocacy group the Alliance for a Stronger FDA, Stephen Ubl, president and chief executive officer of AdvaMed, commented: "We also believe that FDA needs to undertake a concerted review of its many activities to make sure it is focusing its time and resources on those areas that are likely to have the most significant impact in improving patient care".

Conversely, he added, "FDA should determine which of its activities have little or no impact on its mission and could be scaled back without adversely affecting the public health and safety".

Moreover, given its limited resources, the agency "should promote improvements to programmes, such as those that were included in the FDA Amendments Act of 2007, that rely on FDA-trained and -accredited outside third parties to perform specific agency functions. This is a way for FDA to further concentrate its expertise on areas that have the greatest benefit to patients without in any way diminishing the agency's ability to inspect any facility at any time for any reason."