Australia Follows FDA and IMDRF Lead in Regulating Software

Australia’s Therapeutic Goods Administration will likely follow the FDA’s lead and the International Medical Device Regulators Forum’s model for regulating … Read More

FDA Advances Plans for a Digital Health Unit

The FDA is moving ahead with the creation of a Digital Health Unit to address software validation for devices and other issues relating to health information technology. Read More

Experts: Incorporate Cybersecurity Into Design, Development Process

With a number of attempted and successful cyberattacks on hospital networks making headlines, what steps can medical devicemakers take to ensure the security of their products? Read More

Interoperability Growing Despite Lack of Incentives

Governments and standards organizations worldwide are moving toward a healthcare delivery system where devices work together, but devicemakers may need better incentives to get on board, an analyst says. Read More

Report Outlines ‘Building Code’ for Medical Device Software

Developers of medical device software should use secure coding standards that address known memory access vulnerabilities to protect their products from hacking, a new report says. Read More

IMDRF Proposed Document Sets QMS Standards for Device Software

The International Medical Device Regulators Forum has issued a proposed document explaining how to use quality management systems to regulate software as a medical device. Read More

FDA’s Shift on Wellness Products Surprising but Welcome, Expert Says

Manufacturers of general wellness products wondering how the U.S. FDA might regulate their goods should check how the agency deals with similar devices, an attorney says. Read More

Attorney: mHealth Manufacturers Should Consider FCC Requirements in Design

Makers of mHealth products need to consider requirements of the U.S. Federal Communications Commission as well as those of the FDA when designing their products, an attorney says. Read More

FTC Cracks Down on Mole Check Apps, Bars Sales of Two Products

With U.S. FDA plans to use discretion in enforcing most medical app claims, the job of policing the fast-growing industry has fallen to the Federal Trade Commission. Read More

Mobile Apps: Watch Intended Use, Product Codes, Attorneys Say

When it comes to mobile medical apps, the U.S. FDA’s classification process may rest heavily on how the manufacturer describes the product, experts say. Read More