CDRH
This article provides insights into 21 CFR Part 820, including an overview of the regulation, its requirements, and compliance strategies. Table of Contents The US Food and Drug Administration (FDA) is responsible for regulating medical devices marketed in the United...
FDA
The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug...
FDA
The new article provides the details regarding certain specific aspects associated with the quality system information to be provided by the medical device manufacturer applying for marketing approval. Table of Contents The Food and...
FDA
The article describes in detail the mechanisms to be used by the authority to provide its feedback regarding the device development. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
FDA
The new article highlights specific aspects related to the entrance review, the ones the authority will also assess when determining the eligibility of the product and application associated thereto for review under the appropriate framework. ...
