510k Archives

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 Electronic Submissions for 510(k): Current Template

Nov 16, 2023

FDA

FDA Guidance on Electronic Submissions for 510(k): Current Template

The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

Nov 15, 2023

FDA

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.

FDA Guidance on Selecting Predicates for 510(k): Introduction

Nov 15, 2023

FDA

FDA Guidance on Selecting Predicates for 510(k): Introduction

The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.

FDA Guidance on Submission of Premarket Notifications for MR Diagnostic Devices: Overview

Nov 2, 2023

FDA

FDA Guidance on Submission of Premarket Notifications for MR Diagnostic Devices: Overview

The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.

RegDesk Regulatory Roundup

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

FDA Guidance on Electronic Submissions for 510(k): Current Template

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

FDA Guidance on Selecting Predicates for 510(k): Introduction

FDA Guidance on Submission of Premarket Notifications for MR Diagnostic Devices: Overview

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