The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.
The Class I recall is a result of a mold overflow defect that could obstruct blood flow.
Will the return of the 2.3% excise tax change how medtech companies do business?
Failing to report serious patient injuries will win you a warning letter.
Economic development in China has created a burgeoning middle class that demands higher standards of living.
The program intends to promote quality in medical device design and manufacturing.
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.
PwC’s Health Research Institute releases its annual Top Health Issues report.
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.