RegDesk Regulatory Roundup

Apr 13, 2022

DRAP Guidance on Imports & Exports of Therapeutic Goods: Overview

The article provides a brief overview of Pakistan’s regulatory requirements in the sphere of importation and exportation of medical devices and highlights the key points to be considered by medical device manufacturers and other parties involved in placing medical...

FDA Guidance on Substantial Equivalence: Intended Use

Apr 7, 2022

FDA

FDA Guidance on Substantial Equivalence: Intended Use

The new article describes in detail the aspects related to the intended use of medical devices and the ways it should be considered when evaluating substantial equivalence. Table of Contents The Food and Drug Administration (FDA or...

FDA Guidance on Simulated-Use Human Factors Validation Testing: Data Collection

Mar 22, 2022

FDA

FDA Guidance on Simulated-Use Human Factors Validation Testing: Data Collection

The new article addresses the matters related to data collection and describes in detail different types of information and the ways it could be collected. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...

FDA Guidance on Human Factors Validation Testing: Simulated Use and Participants

Mar 18, 2022

FDA

FDA Guidance on Human Factors Validation Testing: Simulated Use and Participants

The new article provides a brief overview of the human factors validation testing and also addresses certain specific aspects associated thereto, including the ones related to the test participants. Table of Contents The Food and Drug...

FDA Guidance on Human Factors and Usability Engineering: Formative Evaluation

Mar 10, 2022

FDA

FDA Guidance on Human Factors and Usability Engineering: Formative Evaluation

The new article addresses specific factors related to empirical analysis (formative evaluation). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...