Medical Devices
FDA APPROVAL
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Medical Devices Companies that wish to export medical devices to the United States must pay the FDA an Annual Facility Registration Fee and register their products after selecting and passing the Premarket Submission.
The American Technology Clinical Solutions Inc. consults FDA-related work for companies that want to export to the U.S. for social contribution and, if necessary, deputizes FDA registration, inspection, approval, and agents through a trusted research institute in the U.S.
To register a medical device, check the classification of the product first to see if it is a product that needs to be registered, whether it belongs to Class I, II, or III, and which of the Premarket Submission should be done.
CDRH Classification Database
The FDA's Classification Database on its Center for Devices and Radiological Health (CDRH) webpage allows you to identify the classification of products you want to export to the United States.
Class I, II, III
| Risk degree | |||
| Class I | Low | General Controls | Toothbrush |
| Class II | Medium | General Controls, Special Controls | Condom, Blood pressure meter |
| Class III | High | General Controls, Premarket Approval | Heart valve |
If the product is checked through the classification database, the product will be divided into Class I, II, and III depending on the risk and the regulations that must be submitted can be checked.
Classification period
About three or seven days
Agency work
- Checking the classification of the product
- Classify classes and confirm the Premarket Submission.
- Acting on other inquiries to the FDA
After product classification, you must check if there is a request for a pre-marketing submission and submit it. Even if the products belong to the same Class I and Class II, the pre-marketing submission may vary depending on the product, so please check carefully. The most common types of pre-marketing submissions are:
510(k)
Some products belonging to Class I and most of Class II products are requested 510(k). The submission of 510(k) indicates that the product is safe to market by informing 'Substantially Equivalent' (equal equivalence) of the products, usage intentions, technical features, and testing results that are currently sold and used safely on the market before the product is safe to market.
De Novo
De Novo is a method of class I or Class II if the new product you intend to sell does not have a similar product that has been sold and used safely in the market.
PMA
PMA is the most stringent type of pre-marketing submission, which includes most of Class III products. Prior to FDA approval of PMA, the safety and efficiency of the use of the product shall be indicated by the scientific evidence that it is warranted.
Registration period
About three to six months
Agency work
- Confirmation of the classification of the Premarket Submission
- Checking and submitting necessary documents such as 510(k), PMA, De Novo, etc.
- Checking and submitting design, labeling, and other evidence
- Acting for cooperation with the FDA in related work
Annual Establishment Registration Fee
Annual facility registration fees are mandatory for FDA-registered companies to export medical devices to the United States, and are not exempt or reduced for small businesses.
| Year | Amount |
| 2020 | 5,236 dollar |
| 2021 | 5,546 dollar |
| 2022 | 5,672 dollar |
| 2023 | 6,493 dollar |
FY 2023 MDUFA User Fees
Under the Medical Device User Fee Amendments, FY 2023 requires the FDA to pay the following fees: Small Businesses with annual sales of less than $30M can be paid with SBD approval at discounted rates as follows:
| Type | Standard fee | Small business fee |
| 510(k) | 19,870 dollar | 4,967 dollar |
| PMA | 441,547 dollar | 110,387 dollar |
| De Novo | 132,464 dollar | 33,116 dollar |
Registration period
About a week or two
Validity period
Until December of the following year after registration
Agency work
- Acting Annual Environmental Registration Fee
- Consulting and acting as a Premarket Submission User Fee
- Acting on other inquiries to the FDA
After classifying the product through the CDRH Classification Database, after completing the required Premarket Submission, you can now register the facility and list the product. Register after completing all of the above courses because you need a pre-marketing submission number and PIN number.
Requirements for product registration and listing
US Agent registration is mandatory for product registration and listing.
| 1 | Ownership of the Medical Device Facility |
| 2 | Facility Information |
| 3 | U.S. Agent Information |
| 4 | Premarket Submission Number |
| 5 | Product |
| 6 | Activites for Listing |
| 7 | Proprietary Name |
| 8 | Importer |
| 9 | PIN, PCN Number |
Registration period
About a week or three
Validity period
Until December of the following year after registration
Agency work
- FDA Industry Systems Account Open
- Handle all work related to product registration and listing.
- U.S. Agent Registration and Cooperation
- Acting as Emergency Contact
- Notify me that I need to extend before the expiration
CS Center
Tel 916) 940-8899 E-mail atcs@atcsfda.com
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