FDA/​Regulatory

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.

Singapore's Health Sciences Authority (HSA), the country’s medical device market regulator, has implemented new rules in order to expedite market access for lower-risk medical devices. The rules will exempt all Class A medical devices (except sterile Class A products) from HSA registration...

Since it was established 11 years ago, the Stanford Biodesign Innovation Program has led to more than 200 patents and 24 start-up companies, including Spiracur, the company behind the SNaP Wound Care System (featured in the January issue of Medical Design Briefs). This intensive one-year program helps...

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...

The IEC 62304 standard for medical device software is causing system engineers worldwide to step back and examine their software development methods with considerable scrutiny. Although at one time, software development and testing was an integral part of overall system design and...