~ Losing Face ~

* Dr. Barry E***** -FDA violations

FDA conducted an investigation at E*****’s site May 18-31, to determine whether activities and procedures related to his participation in the clinical study complied with applicable FDA regulations for medical devices.

Several violations were noted, including that E***** had consistently failed to obtain informed consent, and failed to ensure that the informed consents that were obtained were in accordance with FDA regulations.

For example, E*****’s patient records showed no signed informed consent was available for a subject who was implanted with the study device; and, another patient implanted with the study device did not sign the informed consent form until after the implantation.

Furthermore, the agency said E* had no documentation (other than the initial approval form) onsite to indicate that the IRB was conducting further continuing reviews of the study, although IRB’s are required to conduct continuing reviews no less than once a year, and E* was required to maintain records of all correspondence with the IRB.

Specifically, E*****’s study protocol required that follow-up visits be conducted at one month, three months, six months, 12 months, 18 months and three years. Of the 24 follow-up visits required by the protocol, three visits were missed entirely and many of the others were conducted outside the timeframe required by the protocol, FDA noted.

In addition, the FDA investigator said that no source documentation for several subjects’ previous medical histories, radiographic assessments or other relevant records was available for review. BiMo; Doc. 13952W

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