FDA takes new steps to advance digital health, opening docket to solicit feedback on software products

FDAToday, the FDA is opening a docket to solicit feedback on important provisions of the 21st Century Cures Act ("Cures Act"). The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of a medical device. Under the Cures Act, Congress excluded specific types of software from FDA regulation, including general wellness software products, electronic patient records and more.

As required under section 3060(b) of the Cures Act, the FDA is examining information on these non-device software functions and assessing the impact that such software functions have on patient safety; including best practices to promote safety, education and user competency related to such functions. The agency will publish its findings and issue a report later this year regarding the benefits and risks of these functions.

As part of that effort, the FDA has opened a docket to request public input on benefits and risks to health associated with the software functions excluded from the device definition by the Cures Act. The FDA will incorporate this input as the agency develops its report on these functions.

Comments may be submitted to the public docket here. Please submit comments for consideration in the development of the report by June 28, 2018.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Novo Nordisk announces plans to transform its appr…

Novo Nordisk announced plans to restructure its Research & Development (R&D) organisation to accelerate the expansion and diversification of its pipeline across serious c...

The Merck Accelerator Program 2019

The Merck Accelerator is looking for real partners so that you can work together in shaping the future. With programs in the headquarters in Germany, in China and the Sat...

Imfinzi is the first immunotherapy to demonstrate …

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi durin...

World's largest Alzheimer's survey reveals most ad…

Amgen (NASDAQ:AMGN), Novartis and Banner Alzheimer's Institute (BAI), in association with Alzheimer's Disease International (ADI), announced results from the largest glob...

Pre-clinical success for a universal flu vaccine o…

Researchers from the University of Oxford's Department of Zoology have demonstrated pre-clinical success for a universal flu vaccine in a new paper published in Nature Co...

Discovery could explain failed clinical trials for…

Researchers at King's College London have discovered a vicious feedback loop underlying brain degeneration in Alzheimer's disease which may explain why so many drug trial...

Global survey reveals that physicians need more in…

Results from a new global survey revealed that more than one-third (36%) of the 310 physicians surveyed do not think they have sufficient information required to make inf...

Aspirin found not to prolong healthy aging

Taking a low-dose aspirin daily does not prolong healthy living in older adults, according to findings from the ASPirin in Reducing Events in the Elderly (ASPREE) trial p...

In clinical trials, new antibody therapy controls …

Thanks to improvements in antiretroviral therapy, HIV is now a manageable condition. Yet even the best drugs do not entirely eliminate the virus, which latently lingers i...

The Nobel Prize in Physiology or Medicine 2018 was…

Cancer kills millions of people every year and is one of humanity's greatest health challenges. By stimulating the inherent ability of our immune system to attack tumor c...

FDA approves first treatment for advanced form of …

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squam...

Novartis licenses three novel anti-infective progr…

Novartis announced today that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug cand...