Sarah Roller
This FDA guidance is applicable to all devices as defined undersection 201(h) of the Federal Food, Drug, and Cosmetic Act.However, this guidance does not apply to the use of non-clinical data, adverse events reports, secondary use of clinical trial data, or systemic literature reviews....
Though only recently issued, the final guidance document on design considerations for home-use medical devices has been updated. Clarifying details have been added to sections pertaining to power mains and electromagnetic compatibility. As part of the Medical Device Home Use Initiative, the FDA recentl...
The U.S. Food and Drug Administration (FDA) has announced the priority, “A-list” of medical device guidance documents it intends to publish for fiscal year 2016, as well as a secondary, “B-list” of guidance the agency plans to publish as guidance-development resources permit. ...
As medical devices have grown increasingly complex, so have the regulations surrounding them. This is understandable when you consider the risks posed with software and connected devices. While the U.S. Food and Drug Administration (FDA) has released guidance in the past about security in medical...
The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has released a draft guidance document - and is seeking comments - on how real-world data (RWD) collected from outside the clinical trial process, such as in...
After receiving over 1,800 comments in response to the initial draft, the Food and Drug Administration (FDA) released final cybersecurity guidance for medical devices that applies to devices with cybersecurity considerations, particularly those with a device software function or devices that contain so...
Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its “Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices” in 2005. Over the past 17 years, significant advancements have disrupted the mar...
Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (...
The article offers an overview of the document, titled "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials," which was issued by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. Am...