In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management.  Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.”  The guidance covers the general quality risk management process but discusses the roles and responsibilities...Read More

ZYTO Technologies was issued a warning letter from the FDA for the reason of “the ZYTO Hand Cradle GSR and associated proprietary software is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act,...Read More

ZYTO Technologies, Inc. was issued a warning letter from the FDA for reason “your firm is promoting the ZYTO Hand Cradle GSR and associated proprietary software outside its cleared intended use.” More specifically, Our inspection revealed that the ZYTO Hand Cradle GSR and associated proprietary software is adulterated under section 501(f)(1)(B) of the Act, 21...Read More