Sponsor Fits Prostheses Without FDA Approval
A sponsor-investigator in a device clinical trial failed to get FDA approval before fitting patients with experimental prostheses, according to the agency. The FDA sent a warning letter to Charles Hamlin based on an inspection conducted Jan. 30 through Feb. 21 at the Denver offices of Hand Surgery Associates.
According to the letter, Hamlin enrolled 47 patients before getting FDA approval for an investigational device exemption. The institutional review board (IRB) had given him approval to enroll 12 subjects at most, according to the letter, which was posted recently to the agency’s website.
Many of the case report forms “were completed several months to more than a year after the patient visit” instead of at the time of the visit, the letter said. Hamlin also did not do required follow-up visits within the specified time window.
The letter cited Hamlin for failure to prepare and submit complete, accurate and timely reports of unanticipated adverse device effects. These are supposed to be sent to the IRB as soon as possible but no later than 10 working days after the sponsor or investigator first learns of them.
He also failed to obtain and document informed consent in that he provided no written documentation for three subjects, consented another two using unapproved documents and had three more sign after they received the prostheses, the FDA said.The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6803c.htm.