FDA Guidance on Studying and Marketing Medical Devices – Part One

The FDA provides guidance for manufacturers regarding the steps necessary to obtain FDA approval to market medical devices.

Medical products, according to the FDA, are considered medical devices if the medical devices meet the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. This definition is as follows:

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes… .”

Developers should determine the intended uses and indications for their product.

The marketing of medical devices according to the Federal Food, Drug, and Cosmetics Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299 vary depending on the dangers of the device and the need to reasonable ensure the safety and effectiveness of the device.

Marketing Pathways

The FDA has different marketing pathways:

• Premarket Notification (510(k))
• De Novo Classification Request
• Exemptions
• Premarket Approval (PMA)
• Product Development Protocol (PDP)
• Humanitarian Use Exemption (HDE)
• Biologics License Application (BLA)

We discuss these pathways in more detail below:

Premarket requirements for medical devices

The FDA recommends that developers follow the following four steps (please see part two for the completion of our discussion) to meet the premarket requirements:

Step One: Classify Your Device and Understand Applicable Controls

Developers of medical devices need to start by determining how the FDA classifies their devices. There are three classes of medical devices (I, II, or III). The key classification factor is the degree of risk. Class I is the least risky while Class III has the most risk. As the class level increases, so do the regulatory controls.

The classes, risks, potential harm, and regulatory controls are as follows.

• Class I medical devices. These devices have the lowest risk and have minimal potential for harm. The regulatory controls are general.
• Class II medical devices. These devices have a “moderate” risk. Class II medical devices present a higher level of risk than Class I devices. The regulations are “general and special (if applicable).”
• Class III medical devices. These devices have the highest level of risk. These devices “sustain or support life, are implanted, or present a potentially unreasonable risk of illness or injury.” The controls are general and PMA (pre-market approval).

FDA recommends the following resources to learn more about regulatory controls:

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

There are additional regulations for medical devices that are radiation-emitting electronic products. There are additional regulatory concerns for medical devices that are “combination products” – a medical device plus another FDA-regulated product (e.g. drug, biologics, etc.).

Whether or not your medical device requires premarket approval, you still need to identify its class level to understand which regulatory controls apply.

Step Two: Select and Prepare the Correct Premarket Submission

Our medical compliance lawyers will help you choose the correct premarket submission category and help prepare the appropriate premarket submission. For most medical devices, the classification level determines the premarket submission requirements. There are some medical device types that do not require a premarket submission. If no premarket submission is required, developers can skip to step four (part two of our discussion).

According to the FDA, the most common types of premarket submissions include:

• 510(k) (Premarket Notification)
• PMA (Premarket Approval)
• De Novo Classification Request
• HDE (Humanitarian Device Exemption)

510(k) – premarket notification

The FDA guidelines state that some class I and most class II devices require a 510(k) premarket notification.

To obtain a 510(k), the developer/sponsor must demonstrate that the new device is “substantially equivalent” to a device that has already been approved, in terms of “intended use, technological characteristics, and performance testing, as needed.” The FDA’s resource for 510 (k) approval can be found at this link – Device Advice Premarket Notification [510(k)].

We’ll review with you whether your device is exempt from the 510(k) notification requirement.

Premarket approval (PMA)

Class III devices require a PMA. This type of premarket submission is the strictest. To obtain a PMA, the sponsor must “provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.” The FDA’s resource for a PMA can be found at this link – Device Advice Premarket Approval (PMA).

De Novo Classification Request

This marketing approval process “provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.” The FDA’s resources for a PMA can be found at these links:

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

HDE – Humanitarian Use Exemption

The FDA provides a path for class III devices that are intended to benefit patients with rare diseases or conditions. To be eligible for an HDE, a sponsor must first obtain “designation as a Humanitarian Use Device (HUD), which is granted through an application to FDA’s Office of Orphan Products Development (OOPD).” The FDA’s resources can be found at this link – Designating Humanitarian Use Device (HUD).

Additional FDA resources for HDE market submissions include these links:

• 21CFR 814, Subpart H
• Humanitarian Device Exemption
• Humanitarian Device Exemption (HDE) Program Guidance

Additional FDA premarket submission resources

Additional FDA resources for premarket submissions include the following:

• Send and Track Medical Device Premarket Submissions Online. Applicants can register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.
• CDRH Learn. FDA has a video-based series of educational materials, seminars, and webinars to help applicants.
• 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.” FDA encourages that applicants read their online information and other resources.
• CDRH Breakthrough Devices Program. This voluntary FDA program helps patients have faster access to “certain medical devices that treat or diagnose a life-threatening or irreversibly debilitating condition by speeding up their development, assessment, and review.” “Sponsors can send a Breakthrough Designation request for their device at any time prior to sending the device’s marketing submission.”

Applicants for FDA approval of medical devices must understand the type of approvals applicants need and what supporting evidence applicants must provide. FDA approval includes understanding the classification level for each device and preparing the premarket submission. Our skilled healthcare lawyers can guide you through the compliance process.

Medical device companies should contact Cohen Healthcare Law Group, PC to discuss their FDA compliance requirements. Our experienced healthcare attorneys advise medical companies and practices about healthcare compliance laws and regulations.