FDA
The article provides an overview of the regulatory policy for low-risk medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
FDA
The new article describes in detail the aspects related to a risk-based approach and the way it should be applied concerning computer software assurance for production and quality system software. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The new article describes in detail the aspects related to timing for regulatory procedures in the context of the least burdensome approach. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article describes in detail the process of determining whether computer software used in the context of medical device manufacturing processes should be subject to validation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The new article describes in detail the aspects related to smart regulation and global harmonization for all the procedures and processes related to placing medical devices on the market. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests, and also the availability of EUA templates. Table of Contents The Food and Drug...
