Statement of AdvaMed

We thank the Committee for holding this Hearing today on Import Safety.  AdvaMed represents over 1,600 of the world’s leading medical technology innovators and manufacturers of medical devices, diagnostic products and medical information systems.  Our members are devoted to the development of new technologies that allow patients to lead longer, healthier, and more productive lives.  Together, our members manufacture nearly 90 percent of the $86 billion in life-enhancing health care technology products purchased annually in the United States, and nearly 50 percent of the $220 billion in medical technology products purchased globally.  Exports in medical devices and diagnostics totaled $25.5 billion in 2005, and imports were $23.7 billion.  The medical technology industry directly employs about 350,000 workers in the U.S.

The medical technology industry is fueled by intensive competition and the innovative energy of small companies – firms that drive very rapid innovation cycles among products, in many cases leading new product iterations every 18 months.  Accordingly, our US industry succeeds most in fair, transparent global markets where products can be adopted on their merits, and intellectual property rights are protected.  We strongly support the Administration’s effort to expand market access for US products abroad through the World Trade Organization (WTO) negotiations and new free trade agreements (FTAs), as well as oversight of market access barriers in countries with which we have strong trade relationships.  In addition, we believe U.S. participation in trade agreements is most effective when provisions are enforced.

Import Safety

AdvaMed believes ensuring the safety and effectiveness of medical technology is a shared responsibility between government, industry and users – wherever the product is designed and manufactured.  Government establishes and enforces the laws and regulations intended to provide patients with medical technology that is as safe as possible and functions as intended.  Manufacturers have the obligation to make products and establish quality management systems that comply with these laws and regulations.  Both parties have an interest in promoting public confidence in the medical technologies used in health care delivery.

U.S. Food and Drug Administration (FDA) regulations governing the sale of medical devices in the U.S. are recognized around the world as providing U.S. patients high quality medical devices.  Any medical device sold in the U.S. – including all imported medical devices or devices made with components produced overseas – will have undergone a review and approval process by the FDA, including inspections of the manufacturing facilities for higher-risk products.  Medical devices also are subject to FDA’s post-market surveillance requirements. While AdvaMed members are confident in the safety of their own products, the U.S. Government has much better access to information to assess whether medical devices being imported into the U.S. meet FDA requirements.  We welcome measures that will ensure consistency in the requirements applied in practice to domestically-produced and imported medical devices.

We believe that communication between governments, involving industry in the process, is very important.  AdvaMed has developed good working relations with key regulatory agencies in many countries.  Our approach with both foreign governments and industry is to seek ways to improve information on best practices, communication and appropriate regulatory systems. 

Over the years, AdvaMed and its members have conducted – and continue to conduct -- seminars and training programs for government officials on best regulatory practices.  By improving understanding of international best practices, we believe the safety and effectiveness of medical devices – along with patient access to those technologies -- will be enhanced world wide.

Information Sharing

Under U.S. regulations, the medical technology industry is required to provide FDA information to assist in its enforcement of regulatory requirements.  Such information includes pre-market evidence, which enables FDA to evaluate the safety and effectiveness of a product before it is sold in the U.S.  The industry also provides FDA considerable post-market information, including adverse event reports and notice of significant changes in product design or manufacture, and is subject to ongoing facility inspections.

The U.S. FDA has access to more information on the U.S. medical technology industry than any other regulatory agency in the world has on its industry.  Some of this information is business sensitive and confidential. In the right hands, necessary information can help ensure unsafe products do not reach patients and/or that appropriate and timely corrective action may be taken by industry and government. 

In the wrong hands, this same information can prevent safe products from improving patients’ lives and be used to block market access.  Regulators in other countries who either do not understand, or do not want to understand, or react inappropriately to, the meaning of FDA’s information can cite it to unfairly deny access for U.S. medical devices. Many other countries use industrial policy to foster exports and discourage imports.  We ask that U.S. Government officials recognize these imbalances – regarding the extent of information available, the understanding of regulatory data, and/or the differences in available resources – in FDA compared to the rest of the world when determining information sharing arrangements between governments.

In particular, we make the following recommendations.

• FDA should provide information to foreign governments only to the extent it receives comparable information in return. Since the task of the Interagency Working Group’s activities is to determine ways to protect Americans from unsafe imports, U.S. negotiators should focus on defining the information foreign governments are willing to provide the U.S., and respond accordingly.  
• FDA should provide foreign authorities safety information only on the specific medical technology products that are actually sold in the other country’s market.  Information on other products, which might be similar to products sold in another country, could be misunderstood and/or misused – e.g., as an inappropriate excuse to deny access.
• If information on specific products sold in a foreign country is shared with foreign authorities, FDA should ensure that the information is used appropriately for safety reasons, which might require training for foreign regulators and/or conditions for denying access to any future data if conditions are not met.
• If FDA provides foreign authorities information on a situation labeled a “recall” in the U.S., that term should not be used with foreign authorities unless a product is being removed from the U.S. market. No other country uses the term “recall” for the broad range of actions, characterized by FDA as “recalls.”  While the Global Harmonization Task Force (GHTF) term “field safety corrective action” would be most appropriate, an alternative would be for FDA to simply describe the action taken, without labeling the action a “recall.”
• FDA inspection reports should not be shared with foreign authorities without obtaining a company’s approval.  Such reports contain sensitive and confidential information.  Many countries’ regulatory systems are still evolving, and their inexperience with FDA inspections could cause them to over-react.  Even if confidential information is redacted from FDA submissions, a foreign government is likely to require the U.S. firm to provide all information as a condition for sales. 

Appropriate Regulatory Systems

The GHTF provides excellent guidance documents, with strong emphasis on quality management systems and international standards, as the basis on which to develop regulations for medical devices. The U.S., Europe, Japan, Canada and Australia are founding members of the GHTF and make use of GHTF guidance documents.  Many countries outside of the GHTF membership are developing their own regulatory systems for medical devices and tend to rely inappropriately on regulations for pharmaceuticals and type testing, instead of quality management systems.  The result is that some countries’ regulations and actions do not reflect best international practices and cannot control safety and effectiveness as well as appropriate medical device regulations based on a quality management systems approach.  In addition, some foreign regulations often impose more stringent regulatory procedures on imported products – which can be effectively blocked at the border – than on domestic products. 

FDA should press for a quality system approach as the basis for medical device regulation and the elimination of type testing, especially testing that is redundant and unnecessary.  Foreign countries’ resources could be better used for developing a modern regulatory framework than being expended on outdated, costly and inappropriate procedures.  This approach would be consistent with the Interagency Working Group’s recommendation to use a “video” instead of a “snapshot” to evaluate imports.  Such an approach to assessing and controlling imports, from design to post-market surveillance coupled with a risk management philosophy across the product life cycle, are well-established principles in the medical device sector (FDA quality systems regulation and international medical device quality management systems standard ISO 13485).  We support their broader application throughout the supply chain.  This approach would also encourage international regulatory harmonization.

We recommend that U.S. and foreign governments, in cooperation with U.S. and foreign industry, launch an initiative to assist other countries interested in improving their regulatory regimes for medical technology.  This initiative could focus on greater reliance on the quality management systems approach, international standards and perfecting post-market surveillance systems.

Conclusion

AdvaMed and its members strongly endorse government regulations that promote the safety and effectiveness of medical technology in the U.S. and abroad.  It is in the best interest of patients, clinicians, and our industry that only the highest quality of medical technology is allowed to be placed on the market in any country.  We have made recommendations which we believe will achieve these objectives without imposing barriers delaying or preventing U.S. medical technology from entering other countries.