Device Trials Focus of FDA Warning Letters
The FDA recently posted three separate warning letters to its website citing a sponsor, an investigator and an institutional review board (IRB) for a range of violations. One alleged a device clinical trial sponsor began a study without FDA or IRB approval. Another letter said an investigator enrolled subjects with the wrong type of cancer. The third letter said an IRB approved a protocol allowing children to be enrolled in a device trial without the extra protections required in pediatric studies.
Bentec Medical, a manufacturer of latex-free specialty surgical products and made-to-order products, began shipping an experimental device to investigators before receiving an investigational device exemption from the FDA or approval from the IRB, according to a warning letter the agency sent March 21 to President and CEO Briant Benson.
In a cancer device trial sponsored by BSD Medical, the investigator enrolled subjects with the wrong type of cancer, according to a warning letter the FDA sent March 5 to company President Hyrum Mead. The protocol called for enrolling patients with advanced, persistent or recurrent deep tumors of the pelvis, but two subjects had breast cancer, a third subject had a chest sarcoma and a fourth had cancer of the esophagus.
The Freeport Health Network IRB approved the protocol for a device trial allowing the enrollment of children as young as 12 without the additional safeguards required in pediatric trials, according to a warning letter the FDA sent March 14 to Bhadresh Patel, who chairs the IRB.
None of the recipients of the warning letters responded to requests for comment
by press time. The Bentec Medical warning letter can be found at www.fda.gov/foi/warning_letters/b6296d.htm,
the BSD Medical warning letter can be found at www.fda.gov/foi/warning_letters/b6290d.htm
and the Freeport Health Network IRB warning letter can be found at www.fda.gov/foi/warning_letters/b6293d.htm.
Upcoming Events
-
23May
-
30May
-
13Jun
-
20Jun
-
21Oct