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FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program

Since May 28, 1976, the United States (U.S.) Food & Drug Administration (FDA) has had an alternative in place to the extremely burdensome Investigational Device Exemption (IDE) and Pre-Market Approval (PMA) processes to get new products onto the market, and that alternative is called the 510(k) process. By definition, “510(k) merely refers to the relevant … Continued

NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors

SHANGHAI, CHINA – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, is excited to announce the launch of its newly-developed website to serve as a new resource for Asia-Pacific (APAC) medical device sponsors. The introduction of this highly-anticipated website is … Continued