In early October, FDA held a public workshop to discuss the challenges of regulating medical devices made through additive manufacturing (also known as 3-D printing). Additive manufacturing gives designers the ability to build devices directly from 3-D images, like patient CT or MRI scans. As the push toward personalized medicine continues, 3-D printed devices hold
medical device
Sterility Issues Are on the Forefront of the Federal Government’s Radar
By Shilpa Prem on
Posted in Medical Device
Earlier this month, Customed, Inc. initiated the largest medical device recall ever recorded in FDA history. The recall was of sterile convenience surgical packs and was due to packaging flaws. These flaws could result in loss of sterility and lead to infection. There have also been a number of voluntary recalls on the drug…
The Sunshine Act Also Rises: One More Chance for Medical Device Manufacturers to Prepare
By Robert E. Wanerman on
The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during …