US(FDA) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Administration of American

The department of the FDA responsible for medical devices is the Center for Devices and Radiological Health (CDRH), whose duty is to ensure that the medical devices sold in the US market are safe and effective within a reasonable range when used for their designated purposes, and it is also responsible for the safety of all radiological electronic products.

The Office of Device Evaluation (ODE) of the Center for Devices and Radiological Health (CDRH) is responsible for reviewing all pre-market applications (Premarket Approval, abbreviated as PMA), pre-market notifications (510(K)/Premarket Notification), and pre-market approvals (PMA) applications, as well as all unapproved but to-be-used-in-clinical-trials medical devices, to ensure the safety, effectiveness, and high quality of medical devices and radiological products.

Regulatory Agency's official website link:https://www.fda.gov/medical-devices

Database link:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Administrative Regulation

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

1995 Safe Medical Device Act

Risk Level Classification of Medical Device and IVD Products

Based on risk level, the FDA classifies medical devices into three categories (I, II, III), with Class III posing the highest risk and Class I the lowest. The FDA clearly defines the classification and regulatory requirements for each type of medical device. Currently, there are over 1,700 types of medical devices listed in the FDA's product catalog.

Any medical device seeking to enter the U.S. market must first determine the classification and regulatory requirements for the product. The FDA makes final decisions on detailed device classifications based on recommendations from expert panels, and while regularly publishing classification results, also updates its regulatory codebase annually as needed.

Authorized representative

Foreign enterprises must appoint an American agent to handle communication with the FDA and regulatory af

fairs. This is a mandatory requirement.

Entry Requirements

Manufacturers are required to comply with the FDA's Quality System Regulations (QSR) to ensure the quality and consistency of the production 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 US market. For other Class I devices with different risk levels, product technical documents need to be submitted based on product characteristics to obtain the K number.

Class II: Medium-risk devices. For products that can be exempted under 510(k) for Class II, the registration conditions are the same as those for Class I devices; for other Class II devices, their safety and effectiveness need to be proven through 510(K), and a small number of Class II devices require pre-market approval (PMA).

Class III: High-risk devices. These devices require pre-market approval (PMA), along with detailed clinical trial data and proof of effectiveness.

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

Registration Language

English.

Registration process, duration and official fees

1. Registration Process

The FDA medical device registration process follows distinct pathways based on the device’s classification and risk level.

Class I devices typically follow the simplest path: they undergo Class I Listing and are immediately eligible for Device Listing.
Certain low-risk Class II devices are 510(k)-exempt, requiring only Device Listing without additional premarket submissions.
Most Class II devices require a 510(k) Premarket Notification: innovative devices must first prepare Pre-IDE and clinical data, then submit a 510(k) application for FDA review. Upon successful clearance, the device receives a K-number and proceeds to Device Listing.
High-risk Class II and all Class III devices require the rigorous Premarket Approval (PMA) pathway: sponsors first submit a Pre-IDE, obtain FDA IDE approval, and conduct clinical trials. Next, they prepare and submit a PMA application, which undergoes both initial review and substantive device evaluation by the FDA. If approved, the FDA issues a PMA approval order, and the device completes the final Device Listing step. All pathways conclude with the device being officially listed by FDA.

2. Registration Period

The 510(k) registration process follows a structured timeline defined by FDA and MDUFA requirements. On Day 1, the FDA receives the 510(k) submission. By Day 7, the FDA issues an acknowledgment letter to confirm receipt; if issues with user fees and/or electronic copies remain unresolved, the agency will send a hold letter to the applicant. By Day 15, the FDA conducts an acceptance review and notifies the applicant whether the submission is accepted for substantive review or placed in Refuse-to-Accept (RTA) hold status. The FDA begins its substantive review by Day 60, engaging in direct interactions with the applicant to continue the review process or request additional clarifying information. By Day 90, the FDA issues its final MDUFA decision on the 510(k) submission. If no MDUFA decision is reached by Day 100, the FDA will provide a missed decision communication to identify and discuss unresolved review issues with the applicant.

3. Official Fee

七、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.

八、Notification Template

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