1.
Milbank Q
; 2024 Jan 22.
Article
En
| MEDLINE
| ID: mdl-38253988
Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.
2.
JAMA Health Forum
; 3(1): e214313, 2022 01 04.
Article
En
| MEDLINE
| ID: mdl-36218857