What is a medical device? Who regulates the sale of these products? How is developing a medical device for pediatric use different than use in adults? The resources below are where to begin in the navigation of the US Food and Drug Administration (FDA) and regulations applied to medical devices marketed for sale in the United States. Developing a medical device requires an understanding of the regulations that you, the medical device developer, must comply with, as well as the regulations applied to the device manufacturer.
Primer on the Medical Device Development Process
The FDA provides an overview that summarizes the steps involved in bringing a medical device to market through a regulatory lens. This resource should be a first stop for anyone who intends to develop a medical device for use in the United States, but is unfamiliar with the regulations involved. Click here for the FDA Overview.
FDA Regulatory Requirements for Medical Devices and CDRH Learn
The FDA has provided a web page for industry education called CDRH Learn. The CDRH Learn modules are essential tools for anyone developing a medical device. The series of training modules describes many aspects of medical device and radiological health regulation. The following link shares a transcript overview of CDRH describing the organization chart for the Center for Devices and Radiological Health (CDRH), what the organization does, and a high level overview of device regulations.
Click here for an introduction to CDRH Learn and here to visit CDRH Learn for comprehensive online learning modules.
FDA Division of Industry and Consumer Education (DICE)
The FDA provides pre-filing guidance for those with questions about device development and classification. DICE answers questions by phone and email from industry and consumer stakeholders. Click here to visit DICE.
FDA Device Classification Database
The FDA Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains device names and their associated product codes. A predicate device is a device that has already received FDA approval and could be used in your pathway to regulatory clearance. This resource is helpful when searching for a predicate device. Click here to search the Product Classification Database.
Pediatric Specific Medical Device Considerations
Developing pediatric and orphan products offers a set of unique challenges. Pediatrics covers a number of ages, broken into subcategories, from birth through age 21. If you are developing a product for use in the pediatric population, the following links and resources provide information specific to your device.
Medical Software and App Specific Considerations
Is your software or app an FDA regulated medical device? This topic is often challenging for developers and even the regulators themselves. The claims associated with your medical software or app may subject your product to regulation. The resources below include a downloadable guidance document for consideration, provided by the FDA, and general principles of the development and validation of medical software and mobile applications.
Click here for the FDA Guidance Document on Mobile Medical Applications and click here for general principles of software validation.
Registering Your Company and Product with the FDA
As a developer of a medical device, you are required to register your company with the FDA. Any facility associated with the production or manufacturing of your medical device is also required to register and list with the FDA. The links below provide the necessary resources and instructions for these processes.
Click here for an overview of the process and click here for details around who must register, list, or pay annually with the FDA.
Submitting Premarket Notification: FDA 510 (k)
These resources address aspects of the FDA process for submitting a premarket notification before introducing a device into commercial distribution. These are necessary resources to review and understand if you are developing what may be considered a Class II or Class III medical device.
Click here for a description of the 510(k) program.
Click here to read The New 510(k) Paradigm and learn about alternate approaches to demonstrating substantial equivalence in premarket notifications.
Patient-Reported Outcome Measures: Use in Medical Product Development
The document at the following link provides guidance on how to incorporate the use of Patient-Reported Outcome Measures into product development. These instruments are much more than a satisfaction survey and must be validated questionnaires. Patient-Reported Outcome Measures are valuable tools for evaluating your device or product from the patient’s perspective. Click here for to view the FDA guidance document.
Protecting Human Subjects
The importance of protecting human subjects while conducting device clinical trials cannot be understated. You may find yourself or your company at a point in development when clinical trials or usability studies with patients is necessary. The link below offers a free online certification course from the National Institutes of Health (NIH) that will educate researchers and product developers on the ethical considerations in protecting human subjects in both medical and behavioral research. Click here for to access the course.