FDA Issues Warning Letters To Breast Implant Makers Allergan And Ideal Implant
The US agency warned Allergan about failing to meet postmarket study requirements and Ideal Implant about Quality System Regulation violations.
You may also be interested in...
Allergan PLC announced that it would take its Biocell textured breast implants and tissue expanders off the market worldwide shortly after the US FDA released additional information linking the use of the implants to a rare cancer.
Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.
Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.