Medical Device U.S. FDA Consulting Strategy

Regulatory Strategy

Navigating the regulatory landscape set forth by the FDA can be overwhelming. There are many regulations to sift through and multiple options to meet your end goal of legally marketing a medical device.

Unless you are seeking regulatory acceptance for a device type that you have worked with time and time again, a well-designed, comprehensive strategy should be in place to consider the regulatory path and plan which options(s) should be pursued, such as a Pre-Submission, 513(g), Investigational Device Exemption (IDE), De Novo, 510(k), and Premarket Application (PMA).

Our FDA consultants have experience across all therapeutic areas to advise you on the appropriate paths to market, including a device’s classification and applicable regulations.

We can help you succeed in this process and document a regulatory strategy to consolidate the findings and accurately disseminate your company’s plan to key stakeholders such as project team members, board members, and financial investors.

Pre-Submissions

Medical device manufacturers may seek input and feedback from the FDA prior to a formal submission. This process can be used ahead of investigational applications such as IDE, marketing applications such as 510(k) or PMA, and for other applications such as accessory classification requests.

The FDA has strict guidelines for how to apply for this feedback. It is voluntary, requires a formal written application to which FDA feedback will be provided as a written response and applicants may request a one-hour in-person or virtual meeting to further discuss the agency’s response. Read this helpful summary by the FDA of the Pre-Submission process.

If your regulatory strategy includes pursuing the Pre-Submission process, our consultants are ready to help. We can serve as your liaison to the agency, manage all outreach, author your Pre-Submission, and lead the Pre-Submission meeting. We also are always happy to provide your company’s prepared Pre-Submission and advise in the background.

513(g) Requests

Section 513(g) of the Federal Food, Drug, and Cosmetic Act enables medical device manufacturers to request clarification about how the FDA would classify their device. Per the legislation, companies can submit the request in writing and the FDA is required to respond within 60 days. FDA guidance regarding 513(g) requests is provided here.

Since classification determines the approval process, it’s critical to get this right in order to avoid delays in getting your product to market. Further, as new technologies emerge, it can be more difficult for individuals to easily identify the classification of a new device. Our consultants are available to put together your 513(g) submission and liaise with the FDA on behalf of your company.

Investigational Device Exemption (IDE)

Medical devices that are not yet clinically marketed may be used in a clinical study if an investigational device exemption (IDE) is approved prior to initiating a study. For significant risk devices, approval must be obtained from an Institutional Review Board (IRB) and IDE application must be approved by the FDA. For nonsignificant risk devices, only IRB approval is required.

Our regulatory experts can help determine the risk associated with your device and assist with the steps to approval whether it be IRB approval, IDE application approval, or both. We can also assist with a Pre-Submission if further input is needed from the FDA in order to determine risk and the applicability of IDE for your device. Our team is ready to help in an advisory or full authoring capacity.

510(k) Premarket Notification Submissions

For Class I, II or III medical devices that have been designated by the FDA for 510(k) submission, the submission must demonstrate that the device (subject device) is substantially equivalent to a legally marketed medical device (predicate device). Substantial equivalence indicates that the subject device has the same intended use as the predicate device and is as safe and effective as the predicate device. The FDA provides information on 510(k) premarket notifications.

Some common hurdles companies face with the 510(k) submission process is assessing the technological characteristics of your device, identifying key differences in your device and the predicate device, and determining the type of testing required, if any, to demonstrate substantial equivalence. We will guide you on when objective analyses in lieu of expensive and time-consuming testing might be acceptable by the FDA. Our regulatory experts have experience tackling these hurdles across many 510(k) submissions. Let us apply what we have learned to help you generate a successful 510(k).

Predicate Selection

As mentioned in the 510(k) discussion above, to demonstrate substantial equivalence, submitters must compare their device to a similar, legally marketed device with the same intended use. The agency encourages medical device manufacturers to select a single predicate device, however, more predicates can be selected if necessary. The FDA provides more information about how to find and effectively use a predicate device here.

Narrowing down to your best predicate option can be a challenge. If you need help with the predicate selection process, our regulatory experts can help determine the appropriate product code, identify predicate candidates within that group of devices, and help narrow down to your optimal predicate or help you gauge whether additional predicates may be accepted by the FDA.

De Novo Request

A De Novo request may be submitted to classify a device as Class I or II when there is no legally marketed predicate device and the device may be reasonably considered as low to moderate risk. De Novo requests may be made either in response to a determination of “Not Substantially Equivalent” in response to a 510(k) or based upon the submitter’s determination that there is no predicate against which to determine substantial equivalence. The FDA has information regarding the De Novo process here.

Our regulatory team often recommends that the De Novo pathway be pursued following a high level of assurance from the FDA via a Pre-Submission. If your team is contemplating whether a De Novo classification may be applicable to your device, allow us to help. We will adviseor can author and liaise on your to De Novo request.

Premarket Approval (PMA) Submissions

Premarket approval (PMA) submissions are required for most Class III medical devices. PMAs are the most rigorous submission type due to the high level of risk associated with Class III devices. PMAs differ from 510(k) devices in that rather than showing substantial equivalence to an existing device, the submitter must demonstrate that a device is safe and effective through both non-clinical testing and clinical investigations, provide manufacturing and quality system documentation, and may be subject to a pre-approval inspection. Learn more about FDA PMAs.

Let our team of experienced regulatory experts assist you through the PMA process. We offer a full range of services, from conducting a simple review to authoring your entire submission and serving as the primary correspondence contact with the FDA.