FDA Requirements & Review

Crowdfunding is being used every day to raise money for various causes and to aid in the launch of new products. Spurred on by themes such as “Be the change you want to see in the world,” donors feel virtuous for helping to fund a child’s medical bills or helping a non-profit to provide clean...

Recently, an online discussion board broached the subject of FDA approval for a diagnostic app that might be able to predict when a patient’s condition would relapse. The question postulated whether there was a way to circumvent FDA approval by launching the app in another country and making it available online. And, if...

While historically, the development of new technologies to improve patients’ lives has relied upon experts’ opinions rather than asking patients and families directly what they consider important, this may be about to change. Patients and their care partners are becoming intimately...

The Emergo Group recently posted an advisory that the FDA has revised the fee charged for issuing medical device export certificates in response to higher costs and demand for these documents.

In mid-July, the House of Representatives passed HR 6, also known as the 21st Century Cures Act, which expedites research and development on debilitating diseases and makes it easier to get important treatments to the patients who need them. Among other things, it makes research collaborations easier, reforms and streamlines...

Medical devices are not always one size fits all, especially with regard to child-sized devices. The Philadelphia Regional Pediatric Medical Device Consortium (PPDC) brings together engineers and biomedical researchers from the Children’s Hospital of Philadelphia (CHOP), Drexel...

Now that the Centers for Medicare and Medicaid Services (CMS) has published its long-awaited final rule implementing the Physician Payments Sunshine Act (Federal Register, February 8, 2013), medical device manufacturers can move forward to carry out a familiar task: complying with regulations.

At an estimated $105.8 billion, the U.S. medical device market may be the world's largest, but it could do with a healthy boost of innovation.* According to a recent White House blog post, "In trying to understand why the country’s pharmaceutical, biotech and medical device sectors seem to be...