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Nov 16, 2023

FDA Guidance on Electronic Submissions for 510(k): Overview

The article highlights the key points associated with the electronic submissions template described by the US authority.

FDA Revised Guidance on MR Safety: MRI Safety Labeling

Nov 9, 2023

FDA

FDA Revised Guidance on MR Safety: MRI Safety Labeling

The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.

FDA Guidance on 510(k) Submissions for Ultrasonic Diathermy Devices: Labeling

Mar 6, 2023

FDA

FDA Guidance on 510(k) Submissions for Ultrasonic Diathermy Devices: Labeling

The new article addresses the matters related to labeling requirements the devices should comply with in order to be allowed for marketing and use in the country. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...

FDA Guidance on 510(k) Submissions of Ultrasonic Diathermy Devices: Specific Aspects

Feb 28, 2023

FDA

FDA Guidance on 510(k) Submissions of Ultrasonic Diathermy Devices: Specific Aspects

The new article highlights the aspects related to biocompatibility, electrical safety, electromagnetic compatibility, and the use of wireless technologies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...

FDA Guidance on 510(k) Submissions for Ultrasonic Diathermy Devices: Predicate Comparison and Software

Feb 28, 2023

FDA

FDA Guidance on 510(k) Submissions for Ultrasonic Diathermy Devices: Predicate Comparison and Software

The new article describes in detail the aspects related to comparison to similar medical devices already placed on the market and also outlines the scope of information to be provided with respect to the software used to operate such devices. Table of Contents The...

RegDesk Regulatory Roundup

FDA Guidance on Electronic Submissions for 510(k): Overview

FDA Revised Guidance on MR Safety: MRI Safety Labeling

FDA Guidance on 510(k) Submissions for Ultrasonic Diathermy Devices: Labeling

FDA Guidance on 510(k) Submissions of Ultrasonic Diathermy Devices: Specific Aspects

FDA Guidance on 510(k) Submissions for Ultrasonic Diathermy Devices: Predicate Comparison and Software

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