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. ...
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 article provides an in-depth review of the regulatory requirements for facet screw systems. Table of Contents The Food and Drug Administration (FDA or the Agency), has published a guidance document dedicated to the performance...
