FDAs control over different categories of medical devices

Source:    Published:2024-04-26     Hist:

Label requirements

"Registering a factory for a device or obtaining a registration number does not necessarily mean formal approval of the factory or its products. Any description that creates the impression that registration or obtaining a registration number leads to official approval is misleading and becomes an incorrect identification" (21CFR 807.39)

The product identification and website should not involve a company registration number or mention that your company is registered with the FDA or has been confirmed approved. If the above description appears on the product label or website, it must be removed.

What is QSR 820

Code of Federal Regulations, Title 21

Part 820 Quality System Regulation

QSR includes methods applied to facilities and controls applied to medical device design, procurement, production, packaging, labeling, storage, installation, and service.

According to 21CFR820 regulations, all medical device companies exporting products to the United States and Puerto Rico must establish a quality system in accordance with QSR requirements.

According to FDA authorization, CDRH will arrange inspectors to conduct factory inspections at the company.

During the process of registering, applying for product listing, and going public in a company,

The FDA assumes that the company has implemented quality system regulations;

Therefore, inspections of quality system regulations are usually conducted after the product is launched;

Note: QSR 820 and ISO13485 cannot be substituted for each other.

What is 510（k） 

510 (k) refers to the pre market technical documents submitted to the US FDA before the product enters the US market. Its function is to prove that the product has the same safety and effectiveness as similar products legally sold in the US market, known as Substantially Equivalent SE, which is essentially equivalent.

Essentially equivalent elements:

Intended use, design, use or transmission of energy, materials, performance, safety, effectiveness, labeling, biocompatibility, compliance standards, and other applicable characteristics.

If the device to be applied for has a new intended use, it cannot be considered substantially equivalent.

Type of 510 (k)

Traditional 510 (k): Suitable for new devices, performance reports need to be submitted when there are no recognized standards or smart files.

Special 510 (k): Suitable for minor modifications to instruments, such as equipment changes caused by design controls.

Simplified 510 (k): When a manufacturer guarantees and declares that their product complies with existing FDA recognized standards, they can submit it.