Deciphering New U.S. Laws Around Predetermined Change Control Plans

Deciphering New U.S. Laws Around Predetermined Change Control Plans

By Yu Zhao, Rene Hardee, Randy Horton, Ashley Miller, Michael Iglesias, Roma Williams, and Jaden Maloney This is the second article in our three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II Software as a Medical Device (SaMD) products beyond artificial intelligence/machine learning (AI/ML): Article 1: Medical Device Postmarket Change Controls & FDA 510(k) Software Modification Guidance Article 2 (this article): Deciphering New U.S. Laws Around Predetermined Change Control Plans […]

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