Jan 14, 2014
The US Food and Drug Administration has published draft guidance on how to comply with custom device exemption rules for products intended to treat extremely rare conditions or diseases.
Custom device exemptions were originally laid out in the US Food, Drug and Cosmetics Act, and then changed under the Food and Drug Administration Safety and Innovation Act of 2012. The new guidance is meant to address ongoing questions regarding implementation of and compliance with the exemptions.
The new guidance includes the following components:
Manufacturers whose devices qualify for custom device exemptions generally do not have to meet FDA premarket clearance or approval requirements such as Premarket Approval (PMA) reviews.
The FDA is accepting comments on its custom device exemption guidance through March 17, 2014.
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.
Now that the US Food and Drug Administration’s final guidance on mobile medical apps is finally published, developers and manufacturers should have a much better idea of which products will fall under regulatory oversight in the US and which will not. The guidance divides mobile apps into three broad categories:
The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.