adminrd, Author at RegDesk

Nov 16, 2023

FDA Guidance on Selecting Predicates for 510(k): Devices Cleared Based on Established Methods / Devices That Meet Expectations

The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.

FDA Guidance on Premarket Notifications for MRDD: Testing

Nov 16, 2023

FDA

FDA Guidance on Premarket Notifications for MRDD: Testing

The article highlights the aspects related to physical laboratory testing to be conducted by the parties responsible for magnetic resonance products to ensure they are safe and efficient when used for the initial intended purpose.

Nov 16, 2023

HPRA

HPRA Guidance on Fees: Authorization

The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.

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

Nov 16, 2023

FDA

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.

EDA Guidance on Reporting Adverse Reactions: Minimum Criteria

Nov 16, 2023

EDA

EDA Guidance on Reporting Adverse Reactions: Minimum Criteria

The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.

RegDesk Regulatory Roundup

FDA Guidance on Selecting Predicates for 510(k): Devices Cleared Based on Established Methods / Devices That Meet Expectations

FDA Guidance on Premarket Notifications for MRDD: Testing

HPRA Guidance on Fees: Authorization

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

EDA Guidance on Reporting Adverse Reactions: Minimum Criteria

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