Preparing your medical device for marketing in the United States (US) should begin at the beginning of its R&D pathway. This can minimize development costs, time, other resources, and risks associated with regulatory submission to the Federal Drug Agency (FDA), and ultimately with commercialization. This is an article that outlines 5 Steps to address while studying your medical device and considering marketing it in the US.

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299.

Medical devices that emit radiation are also subject to regulations for radiation-emitting electronic products cited in 21CFR Parts 1000-1050.

Some requirements apply to medical devices before they are marketed (premarket requirements), and other apply to medical devices after they are marketed (postmarket requirements).

You should following 5-Steps before marketing a medical device in the US:

• Step One: Classify Your Device
• Step Two: Choose the Correct Premarket Submission
• Step Three: Prepare the Appropriate Information for your Premarket Submission to the FDA
• Step Four: Send your Premarket Submission to the FDA and Interact with FDA Staff during Review
• Step Five: Complete the Establishment Registration and Device Listing

The first step in preparing a device for marketing is to find the federal regulation that classifies your device. A medical device is defined by law in the section 201(h) of the FD&C Act, and the classification, which may be found in the Code of Federal Regulations, determines the regulatory path and regulatory requirements for your device.

While the FDA will officially classify your medical device when reviewing your premarket submission, it is helpful for you to identify the classification. This will allow you to select the correct regulatory submission path and become aware of the level of regulatory control that is necessary to assure the safety and effectiveness of the medical device.

Medical devices are categorized into one of three classes, based on the degree of risk they present. These classes are as follows:

• Class I – Lowest Risk
  An example of a Class I device is a manual toothbrush. Class I devices are subject to general controls.
• Class II – Moderate Risk
  Examples of Class II devices are male condoms and non-invasive blood pressure monitors. Class II devices are subject to general controls and special controls.
• Class III – Highest Risk
  An example of Class III device is a heart valve. Class III devices are subject to general controls and premarket approval.

To find the classification regulation of your device, see:

• FDA Product Classification Database
• Device Classification Panels
• Classify Your Medical Device
• Medical Device Accessories

Notes:

• • For help determining whether a product is a medical device, refer to Device – Not a Device.
  • If your product is a combination product – a medical device plus another FDA-regulated product (e.g. drug, biologics, etc.), you should contact FDA’s Office of Combination Product (OCP) by e-mail at: combination@fda.gov. Based on your product’s primary mode of action, OCP will tell you which FDA Center that you need to contact in order to market your product.
  • Even if your medical device does not require a premarket submission, it is your responsibility to make sure you have the correct classification for your device.

After the device classification, you then select the premarket submission required for that regulation. The most common types of premarket submissions include:

• 510(k) (Premarket Notification)
• PMA (Premarket Approval)
• De Novo (Evaluation of Automatic Class III Designation)
• HDE (Humanitarian Device Exemption)

510(k)

Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. For information on how to prepare and submit a 510(k), see Device Advice Premarket Notification [510(k)].

Some Class I and Class II devices are exempt from 510(k) if they do not exceed the limitations of exemption stated in 21 CFR xxx.9, where xxx refers to 21CFR 862-892. For example, an elastic bandage classified under 21CFR 880.5075 is exempt from premarket notification, provided that it does not exceed the exemption limitations stated in 21CFR 880.9.

PMA

Most Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device’s intended use.

For information on how to prepare and submit a PMA, see Device Advice Premarket Approval (PMA).

De Novo

De Novo provides a means for a new device, without a valid predicate, to be classified into Class I or II if it meets certain criteria.

For information on how to prepare and submit a De Novo request, please refer to these resources:

• FD&C Act, section 513(f)(2)
• Evaluation of Automatic Class III Designation (De Novo Process) Summaries
• Evaluation of Automatic Class III Designation (De Novo Process)

HDE

HDE provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. In order for a device to be eligible for an HDE, a sponsor must obtain designation as a Humanitarian Use Device (HUD), which is granted through application to FDA’s Office of Orphan Products Development (OOPD).

For information on how to request Humanitarian Use Designation, see Designating Humanitarian Use Device (HUD).

For information on how to prepare and submit an HDE application, please refer to these resources:

• 21CFR 814, Subpart H
• Humanitarian Device Exemption

After you have selected the correct premarket submission type, you must prepare the appropriate information that will be needed. In this section, we identify resources for assistance and information to consider when preparing your premarket submission.

Resources to Help Prepare Your Premarket Submission

The FDA has developed several types of resources to help you prepare your premarket submission. These include the following:

• Device Advice — comprehensive Web-based regulatory assistance
  • To prepare a 510(k), please see Premarket Notification [510(k)]
  • To prepare a PMA, please see Premarket Approval (PMA)
  • To Prepare, see De Novo Request
• CDRH Learn — video-based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts
• CDRH’s Q-Submission Program — prospective applicants of future premarket submissions may request feedback from the FDA through a Pre-Submission, which is part of the Q-Submission Program. Information about this program may be found in the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. We encourage you to read our online information and other available resources prior to sending any request for feedback.
• CDRH Breakthrough Devices Program: This voluntary program helps patients have more timely access to certain medical devices that treat or diagnose a life-threatening or irreversibly debilitating condition by speeding up their development, assessment, and review. Devices subject to Premarket Approval applications (PMAs), premarket notifications [510(k)] or De Novo classification requests may be eligible. Sponsors can send a Breakthrough Designation request for their device at any time prior to sending the device’s marketing submission. This program replaces the Expedited Access Pathway.

Information to Consider When Preparing your Premarket Submission

Design Controls: All Class II and Class III devices must be designed in accordance with Design Controls under the Quality System Regulation (21 CFR 820.30). Some Class I devices are exempted from Design Controls. For guidance on Design Controls, please see: Design Control Guidance for Medical Device Manufacturers.

Nonclinical Testing: The types of information and testing required to market your device are determined by the device classification, mechanisms of operation, technological characteristics, and labeling. Nonclinical testing performed in support of a premarket submission for a medical device must comply with the Good Laboratory Practices (GLPs) in 21 CFR 58.

Clinical Evidence: PMAs, HDEs and some 510(k)s and De Novos require clinical evidence. Prior to initiating a clinical study, the study sponsor may need to obtain approval of an Investigational Device Exemption (IDE) by the FDA. The study will also need to be approved by the appropriate Institutional Review Board (IRB). Clinical studies must comply with all applicable IDE regulations and Good Clinical Practices (GCPs). For additional information on the IDE and GCP regulations, see Device Advice Investigational Device Exemption (IDE).

Labeling: The labeling for a device must be written according to labeling regulations and included in your premarket submission. For additional information, see Device Labeling.