Yet the agency generally allows device makers to start selling their products after they complete 2 years of a 10-year study.
Drug companies and medical device makers are also testing some products on children.
The same group last summer urged government officials to require device makers to pay such expenses.
She has a lawsuit pending against the device makers, the hospital and the doctor involved.
The major device makers deny that safer technology is needed.
The device makers have already begun playing down the study's significance.
The problem is other heart device makers may not want to do business with a company that just walked away from a deal.
Of course, whether consumers care as much about 3D as device makers do is an open question.
If the device makers cared, surely they would do more?
A few hospitals, though, require the device makers and doctors to tell them about the arrangements.