The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
When applicable, the process provides novel products with a speedier route to market.
The agency has issued its list of the most common inspectional observations for FY 2017.
New virtual and in-person workshops will bring together FDA and industry experts and stakeholders on a variety of key issues.
This second article in the 4-part series looks at the use of software in medical devices in non-clinical settings, particularly the home environment. It addresses software’s role in the home healthcare trend, explains the software-related risks that arise from home-use products, and discusses what manufacturers can do to make these products safer.
How do you find meaningful signals in the middle of masses of noise, correctly interpret those signals and apply them for a useful purpose?
With the increase of diabetes prevalence in Asia and the rise of Asia’s middle classes, the demand for newer and better treatments will provide opportunities for Western medtech companies.
By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.
In the past, few people thought about medical devices falling victim to hackers. But as internet technology and changes in healthcare converge, medical devices are proving to be an easier target for hackers than we thought.
10 factors design engineers must consider when creating stick-to-skin medical devices.