RegDesk Regulatory Roundup -- Medical Device and Pharma

Sep 21, 2023

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Class IIb to Class III

The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...

FDA Revised Guidance on Off-the-Shelf Software: Applications

Sep 21, 2023

United States

FDA Revised Guidance on Off-the-Shelf Software: Applications

The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...

Sep 21, 2023

MHRA

MHRA Guidance on IVD Regulations: Specific Aspects

The new article describes in detail various specific aspects related to the regulatory requirements that in vitro diagnostic medical devices are subject to. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority,...

FDA Guidance on Informed Consent: Alternative Treatment and Confidentiality

Sep 21, 2023

United States

FDA Guidance on Informed Consent: Alternative Treatment and Confidentiality

The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...

FDA Revised Guidance on OTS Software: Description

Sep 21, 2023

United States

FDA Revised Guidance on OTS Software: Description

The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...

FDA Revised Guidance on Off-The-Shelf Software Use: Introduction

Sep 21, 2023

FDA

FDA Revised Guidance on Off-The-Shelf Software Use: Introduction

The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in...

RegDesk Regulatory Roundup

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Class IIb to Class III

FDA Revised Guidance on Off-the-Shelf Software: Applications

MHRA Guidance on IVD Regulations: Specific Aspects

FDA Guidance on Informed Consent: Alternative Treatment and Confidentiality

FDA Revised Guidance on OTS Software: Description

FDA Revised Guidance on Off-The-Shelf Software Use: Introduction

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