GAO TARGETS FDA AND MEDICAL DEVICES

“It is imperative that FDA takes immediate steps” to ensure all class III devices undergo “stringent review” before entering the marketplace, says a recent Government Accountability Office (GAO) report. The GAO claims life-sustaining and implantable medical devices such as artificial heart valves and hips are too often brought to market following a less-than-stringent approval process.

The FDA has already acknowledged the need for change. Acting FDA Commissioner Frank Torti recently told members of Congress, “We need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work.”

$1.19M CONTRACT GOES TO NIPTE FOR QBD GUIDANCE ELEMENTS

The FDA awarded a $1.19-million contract to the National Institute for Pharmaceutical Technology and Education (NIPTE) to develop Quality by Design (QbD) guidance on design space specifications. The award's intention is development of specifications allowing for implementation of QbD framework to improve product quality through science and technology. The research is expected to continue through September 2010.

INDIA DELAYS MEDICAL-DEVICE REGULATION

India's proposal to issue separate regulations for its medical-device industry will likely be delayed through the summer because of changes within the government, according to Association of Indian Medical Device Industry (AIMED) Forum Coordinator Rajiv Nath.

“With the transfer of the assistant drug controller, the whole thing has come to a standstill,” says Nath. “The new incoming official will take at least three to four months to study the problem. In the meantime, India's general election (April-May) will further delay the proceedings as the new government will have to look into the matter. This will lengthen the delay to eight to nine months.”

Currently, medical devices in India are subject to the same regulations as drugs. Earlier this year, the Drug Controller General of India said they were working on separate guidelines for the sector and were sending the proposal to industry for its feedback, and that government might issue a separate regulation for the sector.

Demand for separate regulations by India's medical-device sector has been ongoing for more than a decade. To make their voices heard, more than 150 medical-device manufacturers formed AIMED, which represents industry concerns to government officials.

HHS/FDA OFFICES OPEN IN INDIA

HHS/FDA offices are now open in New Delhi and Mumbai, India. HHS/FDA will post 10 officials in India to work with industries that medical products and food to the United States. HHS/FDA will have an office director, four inspectors and five senior technical experts for medical devices, medicines, and food. The personnel will provide technical advice, conduct inspections of facilities that export to the U.S., and work with Indian government agencies and the private sector to develop certification programs.

The offices are part of HHS/FDA's Beyond Our Borders Initiative, which will place 35 HHS/FDA personnel in 14 global locations as part of an effort to expand HHS/FDA consumer-protection efforts beyond the U.S.

In January 2008, Secretary Leavitt and Commissioner von Eschenbach visited India to start discussions with Indian industry about the issue of product safety, and with the Indian government on the potential of posting HHS/FDA personnel to the U.S. Embassy in New Delhi and the U.S. Consulate in Mumbai.

India is the fourth-largest exporter by volume of drugs and biologics. With the opening of these offices, HHS/FDA now has an “in-country presence” in China, Central America, India, and Europe. HHS/FDA plans for 2009 include posting personnel in Mexico, South America, Europe, and the Middle East.

SPINE SURGEONS ADOPT DISCLOSURE POLICY

The North American Spine Society now has a policy requiring doctors involved in research to disclose financial relationships and detail payments they get from medical-device firms. The organization could impose suspensions, expulsion, and other penalties on members who fail to abide by the rules, but the sanctions would not affect a physician's ability to practice.

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