AAMI/FDA International Standards Conference
China Moving ‘Full Steam Ahead’ on Standards
China is “sparing no expense” in promoting its companies in the international arena, particularly in biotechnology and medical equipment, according to a speaker at the 23rd AAMI/FDA International Conference on Medical Device Standards and Regulation.
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Joe Bhatia |
Joe Bhatia, president and CEO of the American National Standards Institute, which coordinates U.S. Standards, said on Wednesday that China is attempting to move “full steam ahead,” especially in biotech and the medical device industries. The country saw 4,000 standards issues between January 2011 and June 2012, with 500 mandated.
China's “best and brightest” are increasingly involved in standards committees because of government backing, as well as the prestige involved in participation. It also is key for the United States and Europe to engage early in standards development, as the Chinese do, Bhatia said. The Chinese, he explained, coordinate with other stakeholders early to gain consensus on positions, so other countries can't wait until later in the process to offer solutions. Doing so could risk alienating the Chinese.
Bhatia was the first presenter at the two-day conference in Herndon, VA, which attracted medical device professionals from around the world eager to learn about the latest standards and regulatory initiatives—both in the United States and abroad.
William Maisel, MD, deputy center director for science and chief scientist at the FDA's Center for Devices and Radiological Health, discussed some of the priorities for his center this year. They include giving U.S. patients access to the highest quality devices in the world; boosting regulatory science; facilitating device approvals or clearances and being proactive in terms postmarket surveillance; and ensuring safe, effective devices are legally marketed in the United States.
When asked how the center was doing in terms of accomplishing its goals in the wake of the sequestration threat, Maisel said his team was “doing reasonably well, all things considered.” He noted that staff are the center's most valuable resources. However, the sequestration threat has affected training, as the center has had to cut down on travel to conferences. In addition, the FDA hasn't been able to use additional user fees because of the continuing resolution.
Maisel also touched on mobile medical apps, which are the subject of congressional hearings this week. He noted that the FDA has made releasing the final guidance on these apps a top priority, adding that the agency is aiming to reduce ambiguity. He also said the agency is sensitive to the needs of industry, and will keep its needs in mind while keeping patient health a priority.
Posted: March 21, 2013