Abstract
To market a Class II medical device, a premarket notification must be filed with required technical information. While the Freedom of Information Act (FOIA) allows the public to request the Food and Drug Administration to disclose a premarket notification, the technical information in such premarket notification is exempt from public disclosure as long as such technical information falls within the definition of “trade secret” under the FOIA. TaiDoc Tech. Corp. v. OK Biotech Co., a state court decision in 2016, further demonstrates that technical information in a premarket notification is also protected under state trade secret law as long as the owner of the technical information has implemented a proper measure to protect secrecy. In addition, the protection extends to trade secrets of a company that manufactures products for the submitter of a premarket notification.
Published Version
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