Regulations and compliance standards are critical in the medical field. When developers put new medical devices on the market, patients and professionals alike need to know that these tools are effective, safe, and worthwhile to use. As such, every single device on the market must undergo a thorough and complex approval process. Product development and manufacturing teams must understand the compliance requirements and regulations ahead of them to design a successful and effective device. Understanding how medical devices are regulated and approved for use makes product conception, design, verification, and release much simpler. It also grants peace of mind for patients and other end-users. Learn about the processes all medical devices must undergo with this rundown.
The Center for Devices and Radiological Health
In the United States, regulation of medical devices falls to the Food and Drug Administration. Within the FDA is the Center for Devices and Radiological Health (CDRH). This organization regulates the companies that manufacture, repackage, relabel, or import medical devices and radiation-emitting products to sell in the United States. The CDRH is responsible for evaluating medical devices to ensure that they are both safe and effective. These evaluations occur both before and after a product enters the market. This continuous monitoring guarantees that only high-quality devices see release.
Device Classification and Regulation
The FDA and the CDRH assign medical devices to one of three categories: Class I, II, and III. These classifications determine how risky a medical device is and therefore how many requirements it must meet. In the United States, medical device developers must comply with the following basic regulatory requirements:
- Establishment registration
- Medical Device Listing
- Premarket Notification (510k) or Premarket Approval
- Investigational Device Exemption for clinical studies
- Quality System regulation
- Labeling requirements
- Medical Device Reporting
These regulatory control requirements increase from Class I to Class III medical devices. For example, a Class I device presents less risk than a Class II or III device, so it won’t need to undergo certain steps, like a Premarket Notification or Premarket Approval. Meanwhile, a Class II device might be exempt from Premarket Approval, but it will need a Premarket Notification. Most Class III devices—like pacemakers or implants—pose a higher risk to users and therefore need Premarket Notification and Premarket Approval.
Understanding how medical devices are regulated and approved for use is important for medical professionals, development firms, and end-users alike. These standards allow the healthcare industry to fill the market with safe and effective products, creating better tests and treatments for patients everywhere.