Regulatory Approval

Our Client: An Australian medical device company engaged Safis to review their 510(k) submission and serve as its U.S. representative agent with the FDA for the submission and review of their first U.S. 510(k) submission.

Safis successfully performed a review of the 510(k) file and identified areas of clarification and improvement needed in order to provide the FDA with the most complete and accurate 510(k) submission possible by the company. The 510(k) was submitted to the FDA within the company’s desired timeframe.

Further, Safis was retained to provide services to review and submit the company’s responses to the FDA response. As well as participate in a conference call with the FDA to address the FDA response to the 510(k) submission.  

At this time, Safis is working with the client to provide all necessary information to the FDA in order to obtain a successful 510(k) approval.