FDA Medical Devices: Important Regulatory Considerations for Companies Seeking to Enter the U.S. Market

The medical device market in the U.S. is very large and attractive to many companies who are located outside of the U.S. Entering the U.S. medical device market requires a comprehensive, integrated strategy that goes beyond U.S. Food and Drug Administration (FDA) product clearance or approval — an effective market strategy must address key regulatory, quality, reimbursement, and commercial considerations.

1. Statutory Definition of a Medical Device

A company seeking to enter the U.S. medical device market must first determine whether its product meets FDA’s definition of a device such that the product would be regulated by FDA.

Under the Section 201(h) U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), a “device” is defined as:

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

1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;
2. 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
3. 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.

The term “device” does not include certain software functions excluded under Section 520(o) of the FD&C Act, such as functions intended for administrative health care support, general wellness promotion, electronic patient records, or data transfer/display without interpretation. Many Digital Health and Software as Medical Device (SaMD) products may fall within these statutory categories or within FDA guidances on software. Understanding the specific indication or intended use of the software will be key in determining the regulatory status for SaMD products.

Key points from the definition of a medical device:

• A device must work primarily through physical, mechanical, or electrical means, not through chemical action or metabolism. For example, a hip implant affects body structure mechanically, while a drug lowering blood pressure works chemically on the body.
• Intended use is critical: The product’s classification, as described in more detail below, depends on what the manufacturer says either explicitly or implicitly for how the product is intended to be used. Intended use can be determined by evaluating how the product is marketed, what claims appear on the label and on any materials that accompany the products including social media and websites, and what company representatives such as sales personnel or social media influencers say about the product.

2. FDA’s Classification System for Medical Devices

The FDA’s Center for Devices and Radiological Health (CDRH) is the part of FDA that has responsibility for the review and clearance or approval of medical devices. Medical devices are classified into Class I, II, or III based on risk, which determines the regulatory pathway and the type of premarket submission to the FDA required before a company may market a product in the U.S.

Premarket submissions may include:

• Section 510(k) of the FD&C Act (Premarket Notification): Some Class I and most Class II devices require a 510(k) clearance. In a 510(k) submission, the company 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.
• PMA (Premarket Approval): Class III devices require a Premarket Approval (PMA). A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the company must provide valid scientific evidence demonstrating safety and effectiveness for the device’s intended use.
• De Novo Classification Request: For novel, low/moderate-risk devices not in existing classifications and where no suitable predicate device is available.

Whether a device is Class I, II, or III depends on risk and is based on the level of “control” (i.e., regulatory requirements) necessary to provide reasonable assurance of the device’s safety and effectiveness:

• Class I (low risk): General controls; many Class I devices are exempt from premarket submission, although some still require a 510(k) clearance or De Novo classification. This class includes low risk products like bandages, standard blood pressure cuffs, and manual stethoscopes.
• Class II (moderate risk): General + special controls; most require a 510(k) clearance to show substantial equivalence to a predicate device or DeNovo classification. This class includes products like insulin pumps, pregnancy test kits, and powered wheelchairs.
• Class III (high risk): General + special controls + PMA, requiring clinical trials. This class includes products like ventilators, heart valves, pacemakers, and certain surgical implants.

Key points from the FDA’s Classification System for medical devices:

It is important to identify whether a predicate device exists for your product and identify any differences between the predicate and your product. A predicate device is a device that most appropriately serves as the basis for your 510(k) product submission and which has undergone FDA review and is either exempt from FDA 510(k) submission or received a 510(k) clearance. It is very important to identify any differences from the predicate device and explain if any differences raise new issues concerning safety or effectiveness. Choosing the wrong predicate device or regulatory pathway can significantly delay entry into the U.S. market.

Define Your Product Clearly

In developing your regulatory strategy, it is critical that the company consider and fully define product characteristics including:

• Medical purpose
• Intended users
• Patient population
• Use environment
• Claims to be made
• Adequate directions for use
• Warnings, precautions and contraindications

Understanding and fully defining your proposed product helps shape the classification, evidence needs, labeling, reimbursement, and ultimately adoption in the market.

3. Build a Strong Evidence and Quality Base

To facilitate FDA review and clearance, it is important to understand FDA requirements for the specific product classification. Generating and assembling the appropriate data and support for the product will help expedite the submission, review and clearance process. Undertaking the following activities will assist companies in building a strong evidence base and in establishing a robust quality management system and organization.

• Review 510(k) summaries for predicate devices.
• Review applicable FDA guidance and standards documents.
• Prepare technical and clinical evidence for the chosen pathway.
• Ensure compliance with the Quality Management System Regulation (QMSR) under 21 C.F.R. Part 820.
• Address cybersecurity concerns if software is involved.
• Maintain consistent manufacturing and supply chain readiness.

4. Additional FDA Requirements and Establishing Market Access Channels

Identifying whether a product is 510(k) exempt, requires FDA 510(k) clearance, or requires premarket approval (PMA) is one of many steps a company needs to take to comply with FDA requirements. The company is also required to and should undertake the following actions:

• Register your U.S. establishment with the FDA;
• Secure Unique Device Identification (UDI) compliance;
• Choose sales channels, e.g., direct, distributors, or Group Purchasing Organizations (GPOs); and
• Build a sales and compliance team familiar with FDA requirements, advertising and promotional issues, U.S. reimbursement and anti-kickback issues, and U.S. hospital purchasing processes. 

5. Coordinate and Integrate Regulatory, Quality, and Commercial Teams

FDA clearance or approval of your medical device is only the initial step. In addition to the areas noted in Section 4, among other areas, your company should ensure that product quality is maintained throughout the product lifecycle, fully investigate and implement corrective and preventive actions for complaints and trends, provide customer field support, investigate and comply with medical device reporting requirements which includes timely reporting certain adverse events and device malfunctions to FDA, and implement reliable product tracing measures that enable efficient market withdrawals or recalls. It is very important to:

• Demonstrate manufacturing consistency and quality.
• Integrate into clinical workflows.
• Provide post-market support.
• Understand and achieve hospital and payer contracting and adoption.

Conclusion: FDA clearance or approval is imperative in order to commercialize your product in the U.S. Market entry in the U.S. can be a complex and difficult process to navigate. Commercial success depends on an understanding of FDA requirements and expectations early, cross-functional planning, accurate classification, robust evidence, reimbursement readiness, and strong commercial execution.