North America | RegDesk | Medical device regulations

Apr 17, 2023

Philippines FDA Guidelines of the Regulatory Flexibility for Class B, C, and D Medical Devices

The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...

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...

FDA Guidance on 510k Submissions for Ultrasonic Diathermy Devices: Overview

Feb 23, 2023

FDA

FDA Guidance on 510k Submissions for Ultrasonic Diathermy Devices: Overview

The article provides an overview of the applicable regulatory requirements and describes the policy the authority intends to apply. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...

FDA Guidance on Pathology Peer Review: Specific Aspects

Feb 23, 2023

FDA

FDA Guidance on Pathology Peer Review: Specific Aspects

The new article highlights the aspects related to the scope of information to be documented in the context of pathology peer review. Table of Contents The Food and Drug Administration (FDA), the US regulatory agency in the sphere of healthcare products, has published...

RegDesk Regulatory Roundup

Philippines FDA Guidelines of the Regulatory Flexibility for Class B, C, and D Medical Devices

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

FDA Guidance on 510k Submissions for Ultrasonic Diathermy Devices: Overview

FDA Guidance on Pathology Peer Review: Specific Aspects

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