#ontheroadwith EMMA International

by | May 14, 2017 | Uncategorized

Spring conference season is upon us and EMMA International has just finished an exciting month of conferences with some incredible organizations we work closely with. If you are not familiar with the Medical Device Manufacturers Association (MDMA), the Manufacturers Association of Central PA (MASCPA), the Food & Drug Law Institute (FDLI), and the Florida Medical Manufacturers Consortium (FMMC), they are all industry leading organizations that do incredible work in both the local and national space. The team at EMMA International wanted to take a moment to share some of the highlights from their annual conferences.

EMMA International was proud to be a Silver Sponsor of this year’s 2017 (MDMA) Annual Meeting. Congressman Erik Paulsen (MN), who has been the lead Republican sponsor of the medical device tax repeal legislation, led the opening remarks at the Opening Reception. At the Chairman’s Reception, the 2017 Leadership Award Winners were given to Congresswoman Elise Stefanik, Congresswoman Mimi Walters and Senator Todd Young. The 2017 Leadership Award Winners were selected based on their, “strong leadership in Congress on issues that promote patient care and innovations in the medical device industry and their efforts to ensure that the United States continues to be the lead producer of cutting-edge technologies and medical advancements”.

The Manufacturers Association of Central PA is the go to turnkey resource for manufacturing trade regionally, based in southcentral Pennsylvania. EMMA International was proud to be a Silver Sponsor of their 111th Annual Event.

As a Bronze Sponsor of this year’s 2017 Food & Drug Law Institute Annual Conference (FDLI), EMMA International ensures to be apprised of the latest policy developments, enforcement actions, and priority initiatives for 2017 from the FDA Acting Commissioner, Chief Counsel, Product Center Directors, and other key leadership. Additionally, EMMA International’s President and CEO, Dr. Carmine Jabri, led a facilitated table topic on Medical Devices & Cybersecurity.

For those of you who were able to attend the Florida Medical Device Consortium (FMMC) Annual Symposium, we hope you had the opportunity to attend the session titled “510(k) Updates: When and How to Work with the FDA on Device Modifications”, moderated by Jan Flegeau, Director of Global Regulatory Affairs at EMMA International. EMMA International was a Gold Sponsor at the symposium, which is considered to be Florida’s premier event for medical device manufacturing firms, featuring nationally recognized speakers, expert panels on regulatory issues and industry trends, legislative updates, exhibiting companies and quality networking opportunities.

 

Emma International

Emma International

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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