Thought Leaders on Laws and Regulations Affecting Health Care and Life Sciences
FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.
The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low…
As we move into 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.
In …
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…
We use cookies on this website to enhance your browser experience. By continuing to use this site or by clicking the button below, you are providing us with your consent to our use of cookies on the site. To learn more about cookies and how we use them, please review our privacy policy.
