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How to get a medical device on the U.S. market, and best practices for maintaining quality, safety and effectiveness



The global medical devices market size is expected to gain momentum by reaching $657.98 billion by 2028.

Current Trends

Market segments include orthopedic devices, cardiovascular devices, diagnostic imaging, in vitro diagnostic, minimally invasive surgery, wound management, diabetes care, ophthalmic devices, dental devices, nephrology, general surgery, and others.

The increasing geriatric population is promoting demand for ophthalmic and orthopedic devices, as these help in reducing impaired vision and hip fractures in the elderly population. According to the World Health Organization, the number of individuals aged 60 and more is expected to reach nearly 2.0 billion in 2050.

Artificial intelligence (AI) helps healthcare professionals improve patient outcomes, reduce costs, increase efficiency, monitor patients remotely via sensors and automate therapy delivery using mobile apps.

Significant advancements in new technologies such as smart gadgets, and other lightweight communication devices are driving medical equipment. Sensors and medical equipment connected to 5G have near-zero latency, allowing them to gather and transfer data almost instantly.

North America’s dominance is predicted to continue. In the United States, there are over 6,500 medical device companies, the majority of which are small and medium-sized enterprises (SMEs).

However, there are also shortages of raw materials for manufacturing, including semiconductors, or chips used in electronic devices and medical robotics.

How to Determine if Your Product is a Medical Device

▪ Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.

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

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(B) 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

(C) 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 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 software functions excluded pursuant to section 520(o).

But, Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the FD&C Act.

▪ Determine if an appropriate product classification exists for your product.

1. Search the Product Classification Database using the quick or advanced option.

2. Search for Similar Devices, here.

3. Search for Similar Devices by Device Listing.

▪ If you would like a formal device determination or classification from the FDA, consider submitting a 513(g) Request.

Low Risk General Wellness Products

FDA’s Center for Devices and Radiological Health (CDRH) does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements including, but not limited to registration and listing and premarket notification requirements, labeling requirements, good manufacturing practice requirements as set forth in the Quality System regulation, and Medical Device Reporting (MDR) requirements.

So, what are low risk general wellness products?

A general wellness product has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

If the answer to any of the following questions is YES, then the product is not a low rick general wellness product.

1. Is the product invasive?

2. Is the product implanted?

3. Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?

Radiation-Emitting Products

In case your device is also a radiation-emitting electronic product, there may be additional requirements.

Cabinet X-Ray Systems (Closed X-Ray Systems)
Compact Fluorescent Lamps (CFLs)
Computed Tomography
Dental Cone-beam Computed Tomography
Medical Lasers
Ultraviolet Phototherapy Equipment – Medical Ultraviolet Lamps and Products
Medical X-ray Imaging
MRI (Magnetic Resonance Imaging)
Radiofrequency and Microwave Products Other than Microwave Ovens
Sunlamps and Sunlamp Products (Tanning Beds/Booths)
Ultrasound Imaging
Ultrasound Products Other than Diagnostic
UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus
X-Ray X-Ray & Particulate Products other than Medical Diagnostic or Cabinet.

Imports & Exports Regulations

FDA Registration


Product Listing


Medical Device Reporting (MDR)

Before you export your medical device to the United States, register your compan with the U.S. Food and Drug Administration, to avoid the detention of your shipment. Initial Importers are also required to register their establishments.

Diagnostic tests, ventilators, and personal protective equipment (PPE), including surgical masks, face shields, respirators, gowns, and gloves, are regulated as medical devices.

Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the FDA. However, additional requirements apply.

Most Class III (high risk) devices require a Premarket Approval (PMA) before they may be legally marketed, while most Class II (moderate risk) devices require a Premarket Notification 510(k) clearance.

FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents, when certain criteria are met, including there are no adequate, approved, and available alternatives.

About 43% of medical devices used in the United States are imported.

When an entry is transmitted during customs clearance, the FDA verifies that the declared manufacturer and shipper are registered, by searching the CDRH’s establishment registration and listing database. The agency also uses CDRH’s data system to verify that the declared importer is registered.

Moreover, if the information does not match, the FDA may gather additional information, or may detain the product. In case a firm lacks the required registration and listing, the product will be subject to refusal.

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