Global EMC Labs was founded based on its expertise in the medical compliance field. Today, it has expanded to other certification categories but its core competency still resides in the medical device regulatory compliance. With that experience we have built a partnership with Nemko Inc. and have qualified to be the only Canadian CBTL lab within the Nemko family for medical products. With this experience in the medical arena, we offer experience and expertise on preaparing a FDA 510(k) submission for the US market. We can assist manufacturers, exporters, importers and distributors of medical devices in understanding the regulations, and implementing processes, procedures and policies to comply with them.
The US Food and Drug Administration (FDA) touches the lives of virtually every American, every day. Stated most simply, FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. FDA-regulated products account for more than 20 cents of every dollar spent in the United States.
In order to market a medical device in the United States, a formalized report must be submitted to FDA for review and acceptance. Global EMC Labs specializes in assisting medical device manufacturers with this process.
FDA is organized into various specialized program Centers that are responsible for protecting the public’s health. At Global EMC Labs, we have extensive experience dealing with the FDA’s Center for Devices and Radiological Health, which is the group responsible for protecting and ensuring the safety and effectiveness of medical devices.
Global EMC Labs will assist you in determining the regulations and requirements that will be applied by the FDA. We then evaluate your product to the applicable requirements and work with you to ensure that your product and your manufacturing processes are in full compliance. We have built our reputation through our ability to move our clients products through the FDA review process quickly and without difficulty.
Obtaining FDA approval
To obtain approval to market your medical product in the USA, a formalized dossier must be completed and submitted to FDA. The type of documentation required for submittal varies depending on the classification of your medical device. Some medical devices may only be subject to general regulations that apply to all devices. Others, such as life-sustaining equipment, require documented clinical and laboratory test data to demonstrate the safety and effectiveness of the device.
Medical devices are classified into three main categories by FDA: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device.
Class I and Class II Medical Devices require a pre-market notification also known as a 510(k). The 510(k) application is submitted to FDA to demonstrate that the medical device is substantially equivalent to an existing, legally marketed device. New product types, and products classified as Class III require a different process called Pre-Market Approval (PMA).
To further assist our clients, Global EMC Labs has supplied the following answers to the following frequently asked questions. Feel free to contact Global EMC Labs if further clarification is required.