4 Steps for Bringing a Medical Device to Market (According to the FDA)

Learn How We Help Medical Device Companies Meet the FDA’s Requirements for Bringing New Products to Market

**Attorney Nick Oberheiden**
FDA Medical Device to Market Team Lead

**Attorney Lynette Byrd**
FDA Medical Device to Market Team Lead
Former DOJ Attorney

Attorney John Sellers — **John W. Sellers**
FDA Medical Device to Market Team Consultant
Former Senior DOJ Trial Attorney

The U.S. Food and Drug Administration (FDA) has regulatory control over all medical devices sold in the United States. Determining if your product is classified as a medical device by the FDA is the first step. The FDA has an in-depth definition of what qualifies as a medical device, including the stipulation that the product cannot be dependent upon being metabolized for achieving its primary intended purposes.

Navigating the appropriate pre-market submission or listing process is a necessary step toward bringing new devices to market, and manufacturers must be prepared to show the FDA what they have done to ensure that their devices are safe and effective for their intended use.

While there are, of course, numerous steps involved in developing a new medical device and bringing it to market, the FDA has outlined four steps that manufacturers must take before they can begin shipping new devices to distributors or healthcare providers. These steps are:

Classify the Device and Understand the Applicable Regulatory Controls
Select and Prepare the Correct Pre-Market Submission
Send the Pre-Market Submission to the FDA and Interact with FDA Staff During Their Review
Comply with the Applicable Regulatory Controls

From the FDA medical device compliance perspective, each of these steps is critical for helping ensure that manufacturers do not run afoul of the Food, Drug, and Cosmetic Act (FDCA) or FDA regulation. The FDA’s Center for Devices and Radiological Health is responsible for the regulation of firms in all stages of medical device manufacturing and distributing. With this in mind, here is an introduction to what medical device manufacturers need to know:

Step 1: Classify the Device and Understand the Applicable Regulatory Controls

According to the FDA, “[t]he first step in preparing a device for marketing in the United States is to determine how the FDA has classified your device.” The FDA doesn’t classify individual devices, but instead establishes three separate classifications—and it is up to manufacturers to determine into which classifications their devices fall. Under the FDCA, a medical device may be classified as either:

Class I – “These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.”
Class II – “Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.”
Class III – “These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.”

The classification of a medical device determines the type of pre-market submission or listing that is required, as discussed in greater detail below. As a result, this is a critical first step, and manufacturers must ensure that they have chosen the correct classification so that they do not either: (i) fail to take the necessary steps to secure FDA authorization; or, (ii) take unnecessary steps (and incur unnecessary costs) that lead to unnecessary delays in bringing their new devices to market.

Step 2: Select and Prepare the Correct Pre-Market Submission

Determining the correct classification for a medical device also determines which type of pre-market submission or listing is required. While medical devices are generally subject to the FDA’s pre-market submission requirements, exemptions allow manufacturers to list qualifying Class I and Class II devices with the FDA rather than going through the pre-market submission process. As the FDA explains, “[a] device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device.” The FDA makes this determination under Sections 510(l) and 510(m) of the FDCA.

When a premarket approval submission is required, manufacturers must choose the appropriate submission process based on their device’s classification. In some cases, manufacturers will have multiple options, and they will need to work with their counsel to choose the option that is most cost-effective. According to the FDA, the most common types of pre-market submissions for medical devices are:

510(k) Pre-Market Notification – 510(k) pre-market notification is an option for non-exempt Class I and Class II medical devices that are “substantially equivalent” to a device that is already on the market.
De Novo Classification Request – De Novo classification is an option for non-exempt Class I and Class II medical devices that do not have a substantially equivalent predicate device but for which pre-market notification is not necessary to provide a reasonable assurance of safety and effectiveness.
Pre–Market Approval (PMA) Application – Class III medical devices and others that do not have a substantially equivalent predicate device (and that do not qualify for De Novo classification) must go through the FDA’s pre-market approval (PMA) process. This is the most rigorous of the FDA’s pre-market submission processes.
Humanitarian Device Exemption (HDE) – The humanitarian device exemption (HDE) allows manufacturers to bring new Class III devices to market without going through the PMA process when they are “intended to benefit patients with rare diseases or conditions.” As the FDA explains, “[i]n order for a device to be eligible for an HDE, a sponsor must first obtain designation as a Humanitarian Use Device (HUD).”

While these are the most common types of pre-market submissions for medical devices, these aren’t necessarily the only options that manufacturers have available. For example, manufacturers can use the FDA’s 510(k) Third Party Review Program in many cases, and the FDA has established an Investigational Device Exemption (IDE) for devices that are intended for use specifically in clinical research applications.

Step 3: Send the Pre-Market Submission to the FDA and Interact with FDA Staff During Their Review

Once a medical device manufacturer has identified the most appropriate means of pre-market submission, the next step is to make the submission to the FDA. The time and effort involved in preparing a pre-market submission for a medical device depend on the specific type of submission required. The PMA process is the most complex by a significant margin; however, 510(k) pre-market notifications, De Novo classification requests, and HDE submissions are all subject to unique (and strict) requirements that manufacturers must meet before they can bring new devices to market.

After making pre-market submissions, medical device manufacturers must be prepared to work with the FDA throughout its two-stage review process. The first stage is the FDA’s administrative review, during which it “assess[es] whether the submission is sufficiently complete to be accepted for substantive review.” If a pre-market submission is sufficiently complete, the FDA then conducts an “interactive review,” during which “FDA staff communicate[] with applicants to increase the efficiency of the review process.” Playing an active role in each of these stages of review is critical for avoiding unnecessary issues and resolving any concerns that FDA staff may have as efficiently as possible.

Step 4: Comply with the Applicable Regulatory Controls

When seeking the FDA’s authorization to bring a new medical device to market, and when marketing authorized devices, manufacturers must strictly comply with the applicable regulatory controls. These regulatory controls are “risk-based requirements that apply to medical devices and give FDA the oversight to ensure the reasonable safety and effectiveness of medical devices.”

The FDA’s regulatory controls fall into two categories:

General Controls – All medical devices are subject to the FDA’s general controls, unless specifically exempted. Among other things, the general controls require: (i) registration of manufacturers’ facilities and listing of their devices with the FDA; (ii) compliance with the Current Good Manufacturing Practices (CGMP); (iii) compliance with the FDA’s labeling regulations; and, (iv) assurance that no medical devices sold in the U.S. are adulterated or misbranded.
Special Controls – Certain types of medical devices are also subject to special controls. These controls address specific health, safety, and effectiveness concerns related to the nature and use of covered devices.

While complying with the applicable regulatory controls is necessary, it is also just one of several ongoing compliance requirements for medical device manufacturers. At Oberheiden P.C., we have extensive experience representing medical device manufacturers in all aspects of FDA compliance, and our lawyers and consultants can work with you and your team to implement a comprehensive compliance program that is capable of withstanding FDA scrutiny.

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: FDA Compliance When Bringing a New Medical Device to Market

What Types of Medical Devices Are Subject to FDA Approval?

Many types of medical devices are subject to FDA approval. Additionally, even if “approval” isn’t required, manufacturers must often still obtain the FDA’s authorization to market a new device through the pre-market submission process. Determining what type of pre-market submission is necessary starts with identifying the device’s classification (i.e., Class I, II, or III) and determining whether any exemptions apply.

How Do I Determine the Correct Class for a New Medical Device?

Determining the correct class for a new medical device involves focusing on the device’s intended purpose and use. While this will be fairly straightforward in some cases, in others it will require a detailed review of the FDCA and the relevant FDA regulations.

How Can I Determine if a “Substantially Equivalent” Predicate Device Exists?

The FDA maintains a database of listed devices, and determining if a substantially equivalent predicate device exists generally involves searching the database (unless a manufacturer is already selling or specifically aware of a relevant predicate device). In all cases, however, properly identifying a predicate device requires experienced FDA compliance counsel.

What Are the Requirements for Registering a Medical Device with the FDA?

The requirements for registering a medical device with the FDA vary depending on the type of pre-market submission that is required. Our attorneys and consultants have extensive experience guiding medical device manufacturers through all stages of the FDA registration process.

What if the FDA Denies My Company’s Pre-Market Submission for a Medical Device?

If the FDA denies your company’s pre-market submission for a medical device, you will want to engage experienced outside counsel promptly. Depending on the current status of your company’s submission, it may be possible to continue working directly with FDA staff, or more formal legal efforts may be necessary.

Schedule an Appointment with a Member of Our FDA Compliance Team

If you need to know more about the FDA’s requirements for bringing a medical device to market, we invite you to get in touch. Call 888-680-1745 or contact us online to schedule a complimentary consultation at Oberheiden P.C.