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. ...
FDA
The new article addresses the aspects related to the factors for Safer Technologies Program (STeP) entrance and review process. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA
The new article describes in detail the core principles of the Safer Technologies Program introduced by the FDA to improve the regulatory framework for certain types of medical devices. Table of Contents The Food and Drug...
FDA
The article provides an overview of the Safer Technologies Program, a special regulatory framework for medical devices introduced in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
