Nov 2, 2011
The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed requirements for medical device labeling to determine whether the agency’s approach is effective and easy to follow.
The regulator is specifically seeking feedback on four points:
Through such feedback, the FDA intends to assess the user-friendliness of medical device labeling data according to health care providers. The agency plans to use comments to help form its approach to standardizing medical device labeling requirements for medical device manufacturers in the US.
The US Food and Drug Administration (FDA) has issued a clarification regarding medical device manufacturers’ and importers’ compliance with
Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations, and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.