Chapter 1 American Administration

1. American FDA

The department of the FDA responsible for medical devices is the Center for Devices and Radiological Health CDRH. Its responsibility is to ensure that medical devices marketed in the United States are safe and effective on a reasonable basis when used for their intended purpose, and it is also responsible for the safety of all radioactive electronics.

Office of Device Evaluation (ODE) of CDRH is responsible for auditing all the Premarket applications and applications of Premarket Approval (PMA) and 510(K)/Premarket Notification, as well as all unapproved medical devices that will be used in clinical trials, to ensure the safety, efficacy and high quality of medical devices and radiological products.

2. Administrative Regulation

1976 Food, Drug, and Cosmetic Act, Medical Device Amendment

1995 Safe Medical Device Act

3. Risk Level Classification of Medical Device and IVD Products

According to the different risk levels, the FDA divides medical devices into three categories (I, II, III), with Class III having the highest risk level and Class I having the lowest risk level. The FDA has clearly defined its product classification and management requirements for each medical device, and there are more than 1700 kinds in FDA medical device product catalogs.

If any medical device wants to enter the U.S. market, it must first confirm the classification and management requirements of the products applied for listing. The FDA makes the final decision on the detailed classification of medical device products based on the recommendations of the expert committee, and regularly publishes the classification results while also updating the regulatory code base every year.

4. Entry Requirements

Manufacturers are required to comply with the FDA's Quality System Regulations (QSR) to ensure quality and consistency in the manufacturing process.

Class I: low-risk devices. For Class I devices that are exempt from 510 (k), only enterprise registration and product listing are required to enter the U.S. market. For other Class I risk level devices, you need to submit product technical documents according to the characteristics of the product to obtain the K number.

Class II: Medium risk devices, for Class II products subject to 510 (k) exemption, subject to the same registration conditions as Class I devices; Other Class II devices require 510(K) for proof of safety and efficacy, and a small number of Class II devices require premarket approval (PMA).

Class III: High-risk devices that require premarket approval (PMA), detailed clinical trial data and proof of effectiveness.

All medical device companies must register and list their products with the FDA.

5. Registration Language

English.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Registration Cycle

3. Official Fee

Chapter 3 FAQ

Q: At the time of applying for a 510K, must the technical parameters of the device submitted for application be exactly the same as the technical parameters of the consistent device?

A: The FDA allows some variation in technical parameters, but it must be demonstrated that these differences do not raise safety and efficacy concerns with the comparison device.

Q: How to deal with that, after submitting the 510K application, FDA determines that the device is substantially not equivalent?

A: Additional information or additional testing: After a challenge from the FDA, the manufacturer is required to provide additional information or perform additional testing to demonstrate the safety and efficacy of the device. This may include providing additional clinical data, laboratory test results or other relevant evidence ‌12.

Modification of design or manufacturing process: If FDA determines that a device has significant differences in technical characteristics from a consistent device, the manufacturer may need to modify the design or manufacturing process to ensure that the device is consistent with the generic device in technical characteristics ‌1.

Resubmit the application: After adding the necessary information or performing additional tests, the manufacturer may resubmit the application. Ensure that all documentation is complete, accurate, and clearly shows the device's similarity to consistent devices ‌23

Q: I want to distribute a product for which another manufacturer has obtained 510K approval and reflect my company's name on the labeling, does it require to reapply a 510K?

A: There are no significant changes to the labeling (e.g., intended use, indications, population, contraindications, contraindications, etc.) and "Distributed by ABC Firm" or "Manufactured for ABC Firm" (21 CFR 801.1) on the labeling, a new 510K application is not required.

Q: What is a U.S. agent and what are his duties?

A: U.S. Agent means a foreign manufacturer | brand | trader who has business in or in the United States is appointed as a registered agent for the purpose of FDA registration. U.S. Agent is a prerequisite for FDA registration.

U.S. agents act as the communication link between FDA and foreign manufacturers | brands | traders. They are not only required to submit application information at the time of registration, but are also responsible for emergency and routine communication. Their duties are as follows:

Document preparation and submission: Responsible for submitting documents required for product registration to FDA. Such as 510 (k) Advance market notification, PMA (Pre-Market Approval) application, alert notification, recall notification and other relevant documents.

Document maintenance and records: Maintain records of these documents for FDA audit and inspection to ensure that documents are available when required.

Information transfer and communication: Responsible for receiving and conveying all information, requirements and notices from FDA to manufacturers, submitting all necessary documents, notices and applications to FDA on behalf of manufacturers, and handling all correspondence and inquiries with FDA, including registration, license, application and other aspects of communication.

Problem solving assistance: Assist medical device manufacturers in resolving and responding to problems with the FDA in the event of product quality, safety, or regulatory issues. Documentation and information may be required to help FDA understand the situation and facilitate resolution of the issue.

[Note] : The FDA will contact the U.S. agent from time to time, and the U.S. agent must be able to answer the phone call from the FDA at any time. For the agent with untrue information, the FDA will require the factory to provide true information, otherwise it will impose penalties or even cancel the registration number of the factory.

Chapter 4 Notification Template