Design Changes: Before, During and After a 510(k) Submission

fdaecopy/ April 11, 2017/ Device Modifications/ 0 comments

This article provides advice on how to manage design changes throughout the regulatory submission process for a 510(k) submission. Your design control procedure defines the process for controlling design changes, but how to do you control design changes in relation to your 510(k) submission process? Design Changes Before You Submit a 510(k) Submission Design teams are always implementing design changes

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NSE letter: A CAPA plan for your 510k process

fdaecopy/ March 28, 2017/ NSE Letter, Pre-Submission Meeting/ 0 comments

Cry, complain, call the reviewer…you might feel a little better, but you received an NSE letter and tomorrow you still can’t sell your device. Instead, try approaching an NSE letter like a CAPA investigation. What is the issue? The FDA determined that your device is not substantially equivalent to the predicate you selected. What is the root cause? There are

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Abbreviated 510k for your submission or a traditional 510(k)?

fdaecopy/ February 7, 2017/ Submission Type/ 0 comments

Article explains how to decide if you can use an abbreviated 510k submission to save 30 days of review time instead of a 90-day traditional 510(k). Last month (i.e., January 2017), there were only 9 abbreviated 510k submissions out of 222 510(k) submissions. The advantage of submitting an abbreviated 510k is that the FDA target for making a substantial equivalence

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Pre-submission Meeting Request Feedback Options

fdaecopy/ January 20, 2017/ Pre-Submission Meeting/ 1 comments

Article analyzes feedback methods offered by the FDA for a pre-submission meeting request and gives you insight to which option is best for your situation. In 2014 the FDA published a guidance document about pre-submission meeting requests (i.e., pre-sub meetings). The purpose of a pre-submission meeting is to ask and obtain answers to your questions directly from the FDA. The

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Format Content of a 510(k) Submission

fdaecopy/ January 13, 2017/ Table of Contents/ 0 comments

Article summarizes format content requirements for a 510(k) submission to the US FDA for medical devices, including volume and document organization. The FDA requires that your 510(k) submission is organized into 20 sections as described in the adjacent table. You must provide both a hardcopy of the submission and an electronic copy (i.e., eCopy) that is identical to the hardcopy

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