Medical Device Registration: What Are the Basics? 

The US medical device registration process can be intimidating, even for US-based manufacturers. There are many different pathways with lots of steps and moving parts. Classification is opaque, and it differs significantly from classification schemes in other markets.  

If you are new to the field of FDA medical device registration or just want a refresher on the essentials, learning the basics can help the process feel a little less overwhelming. At MedEnvoy Global, we’ve helped thousands of companies register their devices with the FDA and thrive in the marketplace. Schedule a consultation today to learn more about how we can help you ensure compliance with your medical device. With over 25 years of experience navigating the complexities of the FDA approval system, our FDA regulatory experts can help you strategize the best path forward for your device.  

Regulation and Approval 

Medical devices and IVDs are regulated by the US Food and Drug Administration (US FDA), but the work of reviewing device submissions and monitoring devices on the market is done by the Center for Devices and Radiological Health (CDRH), a branch of the FDA. Device regulations are codified under Title 21, Chapter 1, Subchapter H of the Code of Federal Regulations (CFR). These rules govern the design, manufacturing, labeling, clinical evaluation, and post-market surveillance of medical devices and IVDs. 

MedEnvoy Global understands the ins and outs of the CDRH, and we are happy to answer your questions about how to navigate their system of regulations. This includes the critical step of class determination.  

Risk Regulation: What Class is Your Medical Device?

A critical phase of device registration is determining the class of your medical device. Devices are classified into three tiers (Class I, II, and III) based on how much risk they pose to a user or patient. Class I devices are low-risk, like bandages, stethoscopes, and bedpans. Class II denotes a moderate to high risk, such as blood pressure cuffs, syringes, and pregnancy tests. Class III devices have the highest risk: implants, stents, and artificial heart valves fall under this category.  

Different classes have different requirements to meet when registering a device: 

• Class I devices are, for the most part, exempt from premarket submission. This means they likely do not require FDA authorization to be distributed or sold. However, they are likely subject to general controls, which are the baseline regulatory requirements for all medical devices enforced by the FDA. Your device might be 510(k) exempt, and MedEnvoy can help you determine if this exemption applies to your device. 

• Class II devices generally require a 510(k) submission to the FDA, as well as general and special controls. These include port-market surveillance, mandatory performance standards, and expanded labeling requirements. 

• Class III devices have the strictest approval process, requiring Premarket Approval (PMA), compliance with general controls, and rigorous tests and trials to prove their safety. 

Regulatory Controls: What Devices Follow Which Controls? 

If your product is considered a medical device (IVDs are regulated as medical devices), you must comply with the regulatory controls assigned to your device type and classification. 

Regulatory controls are the activities you must sustain pre- and post-market to legally sell your device in the US. There are three levels of controls: General Controls, Special Controls, and Pre-Market Approval (PMA).  

General Controls 

General Controls apply to all device classes. They include: 

Establishment Registration and Device Listing: Manufacturers must register their facilities with the FDA, list their devices, and pay an annual fee. Establishment Regulation identifies who makes the device, and Device Listing identifies what devices are made.  

Quality Management System Regulation (QMSR): Ensures Current Good Manufacturing Practices (cGMP) for device design, development, and production. Manufacturers must implement a QMSR-compliant quality management system, and MedEnvoy can ensure that your device meets FDA quality system requirements. 

Labeling: Requires that devices carry proper labeling and Instructions for Use (IFU). Labeling requirements include name and place of business, intended use, and adequate directions for use. 

Medical Device Reporting (MDR): Requires manufacturers, importers, and facilities (such as hospitals and nursing homes) to report adverse events, including device-related deaths or serious injuries for as long as the device is on the market. 

Device Corrections, Removals, and Recalls: Manufacturers must maintain records of all actions that are taken to correct, repair, or remove devices on the market if the actions are taken to reduce a health risk, and under certain circumstances, manufacturers must report this activity to FDA. A Correction adjusts, relabels, or repairs a device. A Removal refers to the physical transfer of a medical device to another location for inspection, adjustment, modification, relabeling, or destruction. A Recall is the broader strategy of removing or correcting a violative product from the market.  

Unique Device Identification (UDI): A standardized tracking system that ensures device traceability throughout the supply chain, from manufacturing to distribution to patient use.  

Special Controls 

Special controls are specific to Class II devices, so Class II devices must comply with both these and the general controls listed above. Special Controls can include: 

• Device-specific guidance documents that explain what testing is required 

• Specific label instructions 

• Performance standards to ensure benchmarks are met for electrical safety, electromagnetic compatibility (EMC), or mechanical reliability 

• Post-market surveillance that tracks the device and monitors its safety and failure rates 

The FDA website lists over 100 Special Controls that various devices must follow. 

Premarket Approval (PMA) 

Class III devices require premarket approval, or PMA, to evaluate the safety and efficacy of medical devices considered to be high risk. PMA requirements are established under 21 CFR Part 814. This is the FDA’s most stringent device marketing application, and approval is required before manufacturers can begin marketing the device.  

When applying for PMA, manufacturers must submit a description of the device, indications for use, alternative practices and procedures, a summary of studies done on the device, and conclusions drawn from the studies. 

Keep in mind that the FDA will tightly scrutinize these applications, and the regulatory specialists at MedEnvoy can walk you through the complete process of a PMA submission.  

Premarket Submission

A key stage for Class III and most Class II devices is premarket submission. In this process, manufacturers must submit evidence of safety and effectiveness before the device can be legally sold. This involves submitting a report of technical, clinical, and safety information about your device for FDA review and authorization.  

Common pathways include the 510(k) presubmission and the De Novo

510(k) Premarket Submission 

This approval pathway involves proving that your device is safe by comparing it to an existing, legally marketed device. For this to succeed, you need to prove that it is “substantially equivalent” to another device (the predicate device). This is one of the most common pathways for bringing Class II devices to the U.S. market.  

However, just because the 510(K) pathway is a common method does not mean that it is easy. At MedEnvoy, we have decades of experience preparing 510(k) submissions, so we can anticipate what the FDA might say about your device. We provide end-to-end support for manufacturers seeking FDA approving through the 510(k) process, including compiling documentation, managing clinical data, and identifying a predicate device. 

De Novo Request 

While the 510(k) process is ideal for devices similar to others already on the market, the De Novo classification involves novel devices that are breaking new ground. This pathway is available for Class I and Class II devices.  

This is a difficult pathway, since you don’t have a pre-existing device to compare it to. Our regulatory experts can decide if this is the best pathway for you, and if so, help you develop strategic approaches that will improve your chances of approval and minimize risks of slowing down the process. 

Contact Our FDA Medical Device Consulting Agents To Learn MoreContact Our FDA Medical Device Consulting Agents To Learn More

If you need help navigating the thorny FDA requirements for registering a medical device, you’ve come to the right place. For more than 25 years, our consultants have helped manufacturers meet their market goals through a mix of: 

• Strategic planning to develop a customized approval strategy based on your specific medical device 

• Preparing and reviewing all necessary documents to ensure they meet FDA standards 

• Communicating with the FDA throughout the approval process to ensure compliance throughout 

• Interpreting the FDA’s feedback into actionable takeaways to streamline the approval process 

Ready to get started? Schedule your discovery call today.