Dec 12 - 8:50
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this...
Dec 3 - 8:49
“Since the President’s Emergency Plan for AIDS Relief (PEPFAR) was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently over 14 million people living...
Nov 26 - 9:27
Established in 1976, a 510(k) is a “premarket submission made to FDA [by medical device manufacturers] to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially...
Nov 8 - 8:07
Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting...
Nov 6 - 3:31
The National Evaluation System for Health Technology Coordinating Center (NESTcc) announced this past Monday that they have selected eight real world evidence (RWE) test cases to properly assess medical device...
