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AK Science Research Intemational Co. AK Science Asia Co.,LTD

1. Licensing Procedure for the U.S. Medical Device
The US medical device industry accounts for more than 40% of the world's market size, so all domestic and foreign medical device manufacturers are making steady efforts to enter the US market.
However, due to the nature of medical devices being directly applied to the human body, each country's government regulates market entry with different strict standards, and the United States also maintains a strict management system. So, checking the licensing procedure of the US medical device is the first step to entering the US market and is essential for continuous sales activities.
2. Laws and Regulations for the U.S. Medical Device
In the United States, medical devices are regulated and managed together with food, drugs, and cosmetics under the "Federal Food, Drug & Cosmetic Act: Federal Food, Drug, and Cosmetic Act". It is also called to FD&C Act or FFD&C Act.
This law, enacted in 1938, has been amended several times, and whenever medical device-related provisions are revised, it is called by a different name appropriate for the revision. The main revision history is as follows.
ㆍThe Medical Device Amendments of 1976 ㆍThe Safe Medical Devices Act of 1990 ㆍThe Medical Device Amendments of 1992 ㆍThe FDA Export Reform and Enhancement Act of 1996 ㆍThe Food and Drug Administration Modernization Act of 1997"
3. Definition of the Medical Device
It refers to instruments, machines and devices that are used for the diagnosis, treatment, alleviation, or prevention of diseases in humans or animals, and their effects on the body structure and functions of humans or animals. It refers to a product that does not affect the body other than its intended purpose in chemical action or metabolism. Also includes diagnostic products used outside the body (in vitro diagnostic products)
4. FDA Legal Actions for Medical Devices
The following administrative regulations may apply to manufacturers, importers, and distributors of domestic and foreign medical devices sold to the United States by the FDA in violation of the Federal Food, Drug, and Cosmetic Act (FD&C), and also to medical products exported from the United States.

FDA or Voluntary Recall - Recall is the process by which harmful products are withdrawn from the market or when additional information is needed for the safe use of the product. Recalls can be initiated by either the FDA or the manufacturer. The FDA's Foreign Affairs Department notifies all recalls, including products exported from the United States. However, foreign governments are not obligated to authorize the return of recalled products.

Warning Letter - FDA writes a letter to the company stating that if the violations described are not corrected, they may follow a more powerful protocol. Before a strict rule is requested, warnings may be issued in advance so that violations that could pose a serious health risk or happen the economic fraud mentioned below, can be corrected immediately.

Subpoena - A subpoena is a formal warning against a company that the FDA intends to sue the company when the violation is not corrected. This could provide an opportunity to convince the company not to sue the FDA.

Complaints - It is criminal actions taken by the FDA against a company or individual responsible for a violation of the rules of past conduct.

Seizure - After a civil suit, or confiscation, where the FDA seeks to remove a certain amount of a product from its business, no one can tamper with it without statutory permission. The plaintiff or the owner of the seized goods is usually given 30 days by the court to respond, but if no action is taken, the court will order the disposal of the goods. If the owner decides to respond to the government complaint, the case will lead to trial. A third possibility is for the owner of the goods to obtain permission to act in court to bring the goods into compliance. Owners must pay bail (bond) to ensure that court orders are carried out, and also pay FDA's oversight of the company's actions to ensure that products comply with regulations.

Fines - Section 303(f) of the FD&C Act authorizes FDA, after an appropriate hearing, to impose fines for device-related violations. This fine may be attempted in addition to other recalls, injunctions, confiscations, and prosecutions. In determining the amount, FDA will consider the nature, circumstances, severity, alarm, and the violator's ability to pay, the impact it will have on the violator if it returns to business and a history of previous violations. This will not exceed $15,000 for each offense, and a total of $1 million per person for all offenses adjudicated in one case.
5. U.S. Legal Requirements for Medical Devices
5.1 Import of the Medical Devices
Foreign companies and U.S. distributors that manufacture medical devices for the domestic market are required to comply with applicable U.S. laws before, during, and after importing medical devices into the U.S.
The Medical Device Amendment to the FD&C Act defines a medical device as “a machine, tool, instrument, device, or implant in other similar related items, including components, parts, and accessories,” in section 201(h).

Foreign establishments that are engaged in the manufacture, dissemination or processing of devices imported into the United States or provided for import must be registered with the FDA. Foreign establishments are also required to continue the listing submission form for medical devices they are exporting to the United States. FDA also reserves the right to enter into joint foreign agreements to expressly deny entry into the United States of nonconforming products.
5.2 U.S. Classification of the Medical Devices
"Medical devices vary in risk and complexity, so they all require the same level of regulation.  So, the US FDA applies all medical devices to one of three regulatory classifications based on the level of regulation required to verify their safety and efficacy. These ratings are:"

Class Ⅰ = General Controls
Class Ⅱ = General Controls and Special Controls
Class Ⅲ = General Controls and Premarket Approval (PMA)

Most medical devices are rated at 21CFR. It is classified in Title 21 Code of Federal Regulations 862-892, where there are approximately 1,700 classifications of medical devices in 16 medical fields. Out of the 1,700 classified devices, 30% are Class I, 60-70% are Class II, and 8% are Class III.
Class I Device - General Regulations
A Class I device is the least regulated product. These medical devices represent the lowest risk to users and are simpler in design than Class II or Class III. Class I 1 must comply with “general regulations” like grades II and III, and general regulations are as follows, and apply to all medical devices.

1. Facility registration of a manufacturer, distributor, packager, relabeler, or foreign company that requires registration under 21 CFR 807.2 using FDA Form 2891.

Submission of a list of medical devices to be released to FDA using FDA Form 2892.
Manufacturing medical devices that meet the quality system regulations (GMP) of 21CFR Article 820
Labeling medical devices based on 21CFR Article 801 or Article 809
Submission of a 510(k) prior to the release of the medical device

hand-held surgical instruments, surgical tables, etc. are included in Class I. Most Class 1 devices are exempt from premarket declarations and quality system regulations.
Level 2 - Special Regulations
Class II devices are cases where general regulation alone is insufficient to confirm safety and efficacy or to provide such confirmation at present. In addition to complying with general regulations, Class II must comply with special regulations. Special regulations include special labeling requirements, mandatory or voluntary performance standards, and post-market monitoring.
Examples of Class II devices are powered wheelchairs, infusion pumps, and dental bone grafts. Class II devices are not usually exempt from premarket notification (510(k)) or quality system regulations.
Class III - Premarket Authorization (PMA)
Class III is the most stringent regulatory scope for medical devices. Class III devices are cases where there is insufficient information to confirm the safety and efficacy of a class III device only through general or special regulations. Class III devices are usually those that sustain human life and may present a potential, unknown risk of illness or injury.

Premarket approval (PM) is essential as a scientific review process to confirm the safety and efficacy of Class III devices. Although not all Class III devices require a PMA, Class III devices that are officially marketed prior to May 28, 1976 will be identified when FDA announces the PMA submission requirements for manufacturers of those devices. Until then, it can be marketed through the premarket notification 510(k) process.

Class III devices that require a premarket authorization application that has already been approved for marketing are:
Products were regulated as new medical devices before May 28, 1976, and also regulated as provisional medical devices.
Products not identified as actually equivalent to devices placed on the market before May 28, 1976.
A pre-market approval application is required for Class III medical devices before the revision according to the 21CFR regulations.
5.3 Requirements of Performance and Effectiveness
Premarket Notification-510(k) The initial process for market placement is a premarket notification or 510(k). Through the 510(k) process, the applicant must state and prove to the FDA that the device distributed on the market legally has the same quality as a device that was distributed on the market on or after May 28, 1976.
If the device is essentially homogeneous, compare it to a legally marketed device:
If it has the same intended use, and
it has the same technical characteristics as a legally marketed device, or
if it has different technical characteristics and provides the following information

- There are no new questions about safety and efficacy, and
- This device is as safe and effective as a legally marketed device.

All 510(k) applications must have detailed information and labeling and may require testing of the technical characteristics of the device and the relevant performance and efficacy risks. Information on performance and efficacy may include technical bench testing, biocompatibility testing, animal testing, and clinical evaluation. Devices that come into contact with the human body must be well combined with living tissues or organs and implanted. And life-sustaining devices require clinical evaluation for Form 510(k).

If the device is determined by FDA to have essential homogeneity, it may be marketed, and if FDA determines that it does not have essential homogeneity, the manufacturer may resubmit a newly drafted 510(k), file a reclassification petition, and the manufacturer must apply for a premarket authorization (PMA).
PreMarket Authorization (PMA)
The most stringent marketing application required by the FDA is a premarket authorization (PMA). Therefore, the PMA application must contain sufficient information to convince the FDA persuasively about the safety and efficacy of the device.
This requires valid and effective data to prove that this device is safe and effective for its intended use, and in most cases requires clinical research (complete report on safety and efficacy) and data on device manufacturing according to regulations. Clinical studies to support premarket approval applications must be conducted in accordance with the IDE regulations. The PMA review process consists of administrative/application review, scientific and regulatory review, advisory committee review/recommendation, and documentation and notification of final approval. In effect, an already approved premarket license application is a personal license awarded to an applicant to market a specific device.

About 1% of commercially distributed medical devices undergo the PMA process. Class III devices marketed through the 510(k) process are preamendment devices for which FDA has not yet requested a premarket approval application. The FDA receives about 50 premarket approval applications per year.

The performance and efficacy of a medical device marketed through the 510(k) process must simply be demonstrated to a degree of intrinsic homogeneity that it must be as safe and effective as a device already on the market. The performance and efficacy of a medical device marketed through the PMA process must be somewhat effective. These devices must, on their own, demonstrate safety and efficacy through valid scientific evidence.