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The House Energy and Commerce Committee voted 54-0 on June 7 to advance the FDA’s five-year user fee reauthorization package to the floor of the House — with several new amendments on devices. Read More
A more practical, streamlined approach to device regulations by the FDA is credited with helping make the agency the first in the world to approve a new heart valve. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials.Read More
Australia’s Therapeutic Goods Administration is proposing to allow the marketing of devices that have already received marketing approval by certain overseas regulatory authorities. Read More