REGULATORY STRATEGY

The bandage we designed for automatic and constant monitoring of wounds would be marketed in the United States, under the regulation of the U.S. Food and Drug Administration (FDA). According to the Code of Federal Regulations Title 21, we found Sections 880.5075 and 862.1120 to be relevant to our medical device. Section 880.5075 classifies an elastic bandage as a Class I device; however, Section 862.1120 classifies a blood gas and pH test system as a Class II device because these measurements can be used to identify a life-threatening infection [1]. Both sections from the Code of Federal Regulations are included in this article. Because this is a Class II device with a substantial equivalence claim, clinical trials and premarket approval (PMA) are unnecessary.

As a Class II medical device, the monitoring bandage requires General Controls such as registration and listing, labeling, and good manufacturing practices as well as a premarket notification 510(k) submission. The 510(k) submission should be mailed to CDRH’s or CBER’s Document Control Center and submitted online as an electronic copy with the user fee payment. An Acknowledgement Letter will be sent once received. The 510(k) will then go under Acceptance Review, where it will be accepted for substantive review or placed on RTA Hold, in which more information is requested. During Substantive Review, a comprehensive study of the submission is completed. The lead reviewer may request more information on the medical device through an Interactive Review with the submitter or an Additional Information Request. If the monitoring bandage is determined to be substantially equivalent to a previous medical device, it is cleared and the FDA will send a decision letter to the submitter [2]. The timeline of communication during the 510(k) process is shown below.

A challenge we will face through the regulatory approval process could be a delay for an RTA Hold or an Additional Information Request. This could significantly impact our timeline, but can be avoided by providing as much information as possible upfront and answering requests in a timely manner.