The whistleblower alleged that FDA employees handling review and approval of medical devices “violated agency regulations” and created “substantial and specific danger to public health and safety” by approving colonography devices for general screening.
According to the whistleblower, the devices were cleared through less stringent 510(k) pathways even though the devices were seeking new “general screening” approvals for their CT imaging devices, and should have followed a premarket approval path.
The individual asserted that there is “insufficient data showing that the use of CT Technology for population screenings outweigh the risks,” according to the report.
The FDA’s science and regulatory staff, as well as the commissioner, reviewed the allegations and the colonography submissions in question and found the predicate devices used for their 510(k) clearances to be valid. In addition, the groups did not find the added risk of radiation exposure form colonographies to be extreme enough to deny approval, saying a review from the Office of Surveillance and Biometrics showed the “benefits outweighed the risks.”
The individual also said FDA employees created another danger to the public by approving CareStream Health‘s digital mammography device for the screening and diagnosis of breast cancer.
The whistleblower said the digital mammography system was approved despite the manufacturer failing to empirically refute questions over the devices’ ability to detect cancers that appear as microcalcifications of the breast. They also said that the FDA brought in outside experts unnecessarily to clear up issues with the device before it was approved.
The whistleblower’s concerns that the Carestream mammography device was approved were put aside by an FDA commissioner review, which found that the Carestream file “documents a lengthy and thorough review in which multiple viewpoints were heard and given a fair hearing,” according to the report.
The Commissioner also dismissed worries over outside experts brought in to advise on the approval, saying the move was “reasonable and responsible.”
The OSC group verified the FDA’s findings on the matter and submitted them in a report to the White House.