Medical devices and the approval processes: United States vs France.

摘要

Redberg rightly supported the plans for the new approval process from the US Food and Drug Administration (FDA) for medical devices. The FDA has announced it will significantly strengthen its premarket clearance process (which is under review by the Institute of Medicine) and the process for developing and reviewing postmarket data. The FDA also has announced a new transparency initiative requiring that clinical data be publicly available. Indeed, a prudent policy is warranted before approval: high-quality clinical data must show that the benefits outweigh the risks.