The FDA regulates medical devices on a three-tier, risk-based approach. While Class I devices, the lowest risk devices, generally do not require FDA clearance prior to marketing, they are still considered “regulated” inasmuch as manufacturers and marketers of these devices must comply with certain FDA regulations.

FDA Regulation of Medical Devices and 510k clearance

Premarket notification or “510k clearance” is a prerequisite to the marketing and sale of most Class II medical devices. In order to secure a 510k clearance, device sponsors must demonstrate a device’s substantial equivalence to previously cleared devices or be considered substantially equivalent to a device that has been marketed prior to May 28, 1976. It is through this premarket notification (510k) submission that the FDA will determine whether your device is at least as safe and effective as another device on the market (“predicate device”) and thereby determine substantial equivalence, allowing you to market your device without formal FDA approval. More information about the regulations pertaining to the 510k process may be accessed at the FDA’s website here.

510k Submission Services

At Shehadeh Giannamore, PLLC, a FDA regulatory attorney can help you with the 510k submission and clearance process by:

• Conducting a review of your device to determine the most appropriate predicate device(s) in order to support your 510k submission;

• Drafting and preparing your 510k submission in accordance with FDA Guidance documents, including those specifically applicable to your particular medical device;

• Submitting your 510k premarket notification to the FDA and acting as the official contact person on your behalf;

• Communicating directly with FDA staff with respect to your 510k submission and answering any informal inquiries necessary in the determination of substantial equivalence, and

• Preparing any responses to requests for additional information, as necessary, to allow the FDA reviewer to make a final decision on your 510k submission.