---
title: Supporting medical device 510(k) submissions
description: Supporting medical device 510(k) submissions
---

[Case Studies Archive - Alacrita ](https://www.alacrita.com/case-studies)

# [Supporting medical device 510(k) submissions](https://www.alacrita.com/case-studies/supporting-medical-device-510k-submissions)

 Written by [John Simpson](https://www.alacrita.com/case-studies/author/john-simpson) | Feb 7, 2017 2:37:25 PM

## Challenge

A company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA.

This was a complex submission that required careful planning in order to expedite the approval process while at the same time maximizing its use over a number of potential measurement parameters.

## Solution

Our medical device regulatory consultant worked closely with the client’s product development and clinical teams to develop a strategy that balanced timelines and cost against the delivery of a marketable product that offered competitive advantages over existing products on the market. The initial approach involved taking a pre-submission route to gain feedback from the FDA on the proposed strategy.

[View full post](https://www.alacrita.com/case-studies/supporting-medical-device-510k-submissions)

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