May 11, 2022
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. ...
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May 7, 2022
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...
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May 2, 2022
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...
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Apr 28, 2022
FDA
The new article addresses the aspects related to the manufacturing information the authority expects to be included in the submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Apr 27, 2022
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...
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