The Food and Drug Administration (FDA) is responsible for monitoring the safety of all medical devices produced, sold, and used in the United States. The FDA does not approve individual devices; instead, manufacturers typically submit a premarket notification to obtain approval for their device as a Class III medical device.

Positive market feedback regarding medical devices increased by 10 percent in 2018, which was partially due to the emergence of new technologies. For example, artificial intelligence and data analytics are now being applied to healthcare solutions, and the Internet of Things is enabling remote monitoring solutions.

However, the potential risks associated with these devices are also more significant than those found in other categories of medical devices. This blog post answers some common questions about which kinds of medical devices require FDA approval, and which do not.

Medical standards are used to ensure quality and consistency across the industry. These standards are put into place to ensure that patients receive safe and high-quality care every time they visit a medical facility or get medical care.

The International Organization for Standardization (ISO) creates global medical standards. These standards are created in collaboration with medical experts and organizations worldwide. These medical ISO standards are developed based on the most up-to-date research available. The standards help ensure that all medical facilities use best practices and provide optimal care for their patients.

Medical standards can be broken down into two categories:

  1. Clinical standards: These standards address best practices for patient care, such as infection control, privacy, and confidentiality.
  2. Quality management standards: These standards address best practices for quality assurance, such as internal audits and reporting metrics.

These two categories of standards work together to ensure that all medical facilities provide safe and high-quality care for their patients. Third parties can hold medical facilities accountable if they fail to meet these ISO medical standards.

Which Types Of Medical Devices Require FDA Approval?

Medical devices fall into three classes: Class I, Class II, and Class III. A class I device is a low-risk device that does not require FDA approval. Class II devices are moderate risk and require the manufacturer to submit a 510(k) to ensure the device is sufficiently similar to an existing, premarket device. Class III devices are high risk and require clinical trials to demonstrate safety and effectiveness. Examples of standard medical devices include stents, pacemakers, and surgical mesh.~

In addition to being approved by the FDA, medical devices must also comply with state regulations and other local requirements.

Which Medical Devices Do Not Require FDA Approval?

Many medical devices are exempt from FDA approval. These include most rehabilitation equipment, dental floss, blood glucose monitors, and blood pressure monitors. An exception would be home glucose monitors for people with diabetes. These require FDA approval.

There are many reasons why a device may not need to be approved by the FDA. First, it may fall under an exception category. For example, most rehabilitation equipment does not require FDA approval because it is meant for disabled people. Additionally, some devices are exempt because they are believed to be low-risk enough that additional testing is not required. Finally, some devices may be exempt because they do not fall under FDA jurisdiction. For example, over-the-counter drugs and tobacco products do not require FDA approval.

Depending on the circumstances, you may need to get clearance from the FDA before you can sell your device. Therefore, it is best to consult with an attorney or agency (like Pathway NPI) that is familiar with FDA regulations before you begin selling or marketing your device to ensure that you comply with all applicable regulations.

FDA Certification for Medical Devices

FDA certification is needed for a medical device used in the U.S. market. The device must meet all the requirements set by the regulatory body. It is important to note that FDA approval is not necessary for all medical devices set to be used in the U.S. market. For example, there are times when a device will only be used within a hospital or a clinic. In these cases, FDA approval may not be necessary.

FDA certification also ensures that the device has been adequately tested and meets specific safety standards. It can also help improve patient safety.

Two main types of medical devices are FDA-approved: Class I and Class II. Class I medical devices are low-risk and have little risk of adverse effects such as infections or allergic reactions. These devices include bandages, crutches, and tourniquets. Class II medical devices are medium-risk and have some risk of adverse effects. These devices include surgical instruments, pacemakers, and hearing aids.

FDA Class 1 Medical Device Examples

The FDA designates a Class 1 medical device as low-risk and low complexity. See the list of FDA Class 1 Medical Devices.

People with allergies, asthma, and diabetes most commonly use these medical devices.
Class 1 medical devices include:

  • Stethoscopes
  1. Stethoscopes are classified as Class 1 medical devices and are subject to FDA regulation in the same way as other medical devices. All stethoscopes must go through rigorous testing before being sold on the market.
  • Bandages
  1. A medical bandage is a dressing used to cover wounds and injuries on the skin. This dressing can be made of many materials, such as gauze, cotton, and tape. In addition, some bandages are impregnated with antibiotics to help fight infection. Bandages come in many shapes and sizes and can be used in many different ways.
  • Bedpans
  1. Bedpans are used by patients who are unable to use the toilet. Bedpans may be made of plastic, metal, or ceramic. Bedpans are classified as Class 1 Medical Devices for their ability to transfer liquids or solids from one place to another.
  • Tongue depressors 
  1. Tongue depressors are triangular, flat pieces of wood used to lift the tongue and make it easier for a person to breathe. Tongue depressors are also used to scrape bacteria from a person’s teeth or gums and to hold food in place while someone is eating. Tongue depressors are considered Class 1 medical devices by the FDA and can be purchased over-the-counter or through medical supply companies.
  • Latex gloves
  1. Latex gloves are a class 1 medical device used throughout the healthcare industry. They serve as a barrier to preventing the spread of infection and are particularly useful in situations where two people are coming into contact with bodily fluids.
  • Surgical masks
  1. Surgical masks are a Class 1 medical device that is used to prevent the transmission of airborne infections. These masks are suitable for use in hospitals, clinics, and other medical environments. It is also helpful for personal use by those with compromised immune systems and those who are generally more vulnerable to infection (e.g. children).
  • Irrigating dental syringes
  1. Irrigating dental syringes are a Class 1 medical device used for rinsing teeth. It is used to clean out plaque and bacteria from teeth to prevent tooth decay and gum disease. There are many different irrigating dental syringes, from manual needles to electric ones.

A medical device contract manufacturing business like Pathway NPI can be a good fit for companies that either lack the expertise or the capacity to manufacture their products in-house.

Work With the Team at Pathway NPI

We recommend working closely with a team that has expertise in navigating every potential pitfall during the design phase of your viable medical device.

Since regulatory strategy may make or break the journey to FDA approval, it is critical to identify the device’s intended usage and move to the regulatory phase. The FDA branch that oversees medical device licensing and quality assurance processes is known as the Center for Devices and Radiological Health (CDRH). A consultant evaluates the design, evaluates the FDA’s range of current products, and provide a summary report on a potential testing roadmap and marketing introduction strategy.

We can deliver more unified results. The Pathway NPI team integrates product design, quality assurance, and manufacturing processes to provide efficient and successful solutions for removing obstacles along the way.

We get down in the trenches with our clients, developing medical device technology that will be successful in the marketplace. Our unique and agile product development approach, in conjunction with our integrated quality control system, helps us cut down the FDA approval process. While the timeframe and requirements for your product are dependent on each other, we believe that our integrated quality control system contributes a great deal to our success.

Are you unsure about your compliance and regulatory responsibilities? Please contact us for a free consultation! Pathway NPI is an efficient, one-stop solution for bringing new innovations to the U.S. healthcare market.