Nan Lou

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Court Rejects FDA’s Interpretation of the Statute’s Device Definition as “Erroneous and Unreasonable”

The United States District Court for the District of Columbia, in Prevor v. FDA (Prevor II), rejects for the second time FDA’s “erroneous and unreasonable interpretation” of the definition of “device” under the Federal Food, Drug and Cosmetic Act (FDCA) (op. at 21).  The court has remanded the case to FDA to use a lawful standard … Continue Reading

CFDA Announces “Five Rectifications Campaign” Targeting Medical Devices

On March 13, 2014, the China Food and Drug Administration (CFDA) announced the Five Rectifications Campaign, a special five-month enforcement campaign targeting medical devices. The Campaign will focus on medical device registration, manufacturing, distribution, advertising, and use in healthcare institutions.  The campaign began on March 15, 2014 and will end on August 15, 2014.… Continue Reading

DC Circuit Affirms FDA Regulation of Mixture Used in Stem Cell Therapy as a Drug and Biological Product

One of the key issues for the development and commercialization of adult stem-cell treatments is the extent to which FDA can regulate such treatments as drugs or biological products.  This includes a physician’s medical treatment of his or her patient with the patient’s own stem cells.  Though FDA issued regulations applicable to “human cell, tissue … Continue Reading

CFDA Issues Proposed Regulations on Medical Devices

On March 20, 2013, the China Food and Drug Administration (CFDA) released for public comment two proposed regulations on medical devices.  The comment period for the proposed regulations ended on March 31, 2013. The first proposed regulation — titled Special Review and Approval Process for Innovative Medical Devices (Interim) (draft) — provides for special review … Continue Reading