Recipient: OptoviIe, Inc.. Product: RTVue Optical Coherence Tomography (OCT) with the Normative Database (NDB) Date: 6/11/10 Our inspection revealed your device 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, 21 U.S.C....Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.