FDA/​Regulatory

According to the late, great David Bowie, “the stars look very different today”. After two years of collecting the 2.3% Medical Device Excise Tax, the tax has now been suspended for all of 2016 and 2017 when President Obama signed the Consolidated Appropriations Act of 2016. The tax was expected to raise almost $30 billion over...

The FDA’s Center for Devices and Radiological Health (CDRH) announced the 2015 Experiential Learning Program (ELP) General Training Program, which is intended to educate CDRH staff regarding the policies, laboratory practices, and challenges faced in broader disciplines that impact the medical...

IEEE, Piscataway, NJ, has announced a new standard and two new standards development projects designed to support plug-and-play, interoperable communications across eHealth devices. The new eHealth standard is IEEE 2410™-2015, Biometrics Open Protocol Standard,...

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...

On October 14, the FDA issued a draft guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The studies utilized for the assessment of these devices typically provide initial evidence of device...

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...

OpenFDA is releasing a treasure trove of information on medical devices that could help spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands the previous resources about medical device-related adverse events and recalls by incorporating information...

The FDA is seeking companies to take part in a pilot program that would allow medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis. This pilot program will help the agency develop criteria for quarterly malfunction reporting...

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...

The FDA is seeking comments of a new draft guidance that it recently issued for industry called “Adaptive Designs for Medical Device Clinical Studies.” An “adaptive design” for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications...

The U.S. Food and Drug Administration has withdrawn 47 draft guidance documents published before December 31, 2013, which were never finalized or acted on. The announcement was posted in the Federal Register, stating that this move was made to improve the efficiency and transparency of the guidance...

Medical device regulators at the FDA have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.