Registering a new medical device with the FDA can be a huge undertaking, and understanding the process and all of the requirements as early as possible is important. This article provides a high-level overview of the steps required before marketing and selling a medical device in the United States. We’ve done our best to include relevant links to both FDA documentation and educational materials wherever possible!
FDA medical device registration steps
Classify your medical device
Classifying your medical device should be one of the first steps in any FDA submission. The FDA classification system is a “predicate-based” system in which devices are classified based on similar devices that are already on the market in the U.S.
You may already have an idea as to which of the three device classes your product falls under, but you still need to determine the specific device category described within 21 CFR Parts 862-892. The FDA provides a good overview and listing of device categories that is searchable.
This will allow you to determine which specific section of the regulation pertains to your device, which will then define the classification and relevant premarket requirements.
While the majority of Class I devices require no premarket notification, the majority of Class II devices require 510(k) premarket notification, and the majority of Class III devices require a premarket authorization submission, however,this is not always the case.
Medical device manufacturers can request information and guidance from the FDA regarding the classification of a device through a 513(g) request. For the classification of accessories to your device, a pre-submission may be more appropriate (discussed below)
Collaborate with the FDA prior to your submission
Image Source: fda.gov
The FDA encourages pre-submission collaboration meetings and communication as early in the product development process as possible. It is in the best interest of organizations seeking approval of a medical device to have an open dialogue with the FDA, enabling the FDA to advise before and during the submission process, provide direction on Investigational Device Exemption (IDE) applications, and identify any potential concerns that may affect approval or clearance of the device.
This is especially important for devices with novel technology. There are a number of pre-submission activities defined in the FDA’s “Q-Submission” program (these were previously referred to as “pre-ide” meetings). Q-subs provide an organization with the opportunity to obtain feedback from the FDA before a premarket submission is made.
The most common Q-subs are:
Pre-submission (pre-sub) requests provide an opportunity for an organization to obtain feedback from the FDA before completing a premarket submission. Pre-sub requests are made in writing to the agency and can involve a meeting if requested by the submitter.
The submitter should have specific questions prepared regarding their submission and/or product development prepared for the FDA to review during this meeting.
Informal Meetings are requests to share information with the FDA with no expectation of feedback. This may be helpful if your team has a variety of submissions planned, or if your company would like to explain the technology of your device.
Early collaboration determination meetings are requests by a PMA applicant for the FDA’s determination of the type of valid scientific evidence required to demonstrate that the device in question is effective for its intended use.
Early collaboration agreement meetings are used to reach an agreement between the FDA and the submitter on key parameters of the investigational plan.
Results of early collaboration determination and agreement meetings are binding on the agency. For additional information, see “Early Collaboration Meetings Under the FDA Modernization Act: Final Guidance for Industry and for CDRH Staff”