FDA Small Business Qualification Application

The FDA has published various registration fees for medical devices for fiscal year 2024 (October 1, 2023, through September 30, 2024). The FDA's registration fees continue to rise year after year, which the agency says is due to factors such as inflation. For example, the 510(k) registration fee for fiscal year 2024 grew from $19,870 in fiscal year 2023 to $21,776, a 9.5% increase.

Small businesses have received a reduction in a number of expenses. The FDA uses different criteria to define small businesses, depending on the purpose and plan, and implements some degree of assistance for this type of business.

In the field of medical devices, for example, the Center for Devices and Radiological Health (CDRH) under the FDA mainly provides the opportunity for small businesses to reduce part of the cost through the Small Business Determination (SBD) process. ‍

Introduction of Small Business

For medical device user fees in 2023, the FDA defines small businesses as those (including their affiliates) with annual gross revenue and sales of $100 million or less.

Advantages of small business

If you are certified as a small business, you will receive a fee waiver for the following types of applications:

• Pre-marketing Notification (510(k))
• De Novo request
• Premarketing applications, including PMA, BLA and PDP
• Premarket Report (PMR)
• PMA / BLA Supplement
• PDP Supplement
• PMA Annual Report
• 513(g) Classification Information Request

In addition, businesses applying for fee waivers can apply for certain additional fee waivers, such as being eligible for a "First Premarket Application" fee waiver, if their annual gross revenue does not exceed $30 million.

To be certified as a small business, a business must submit an application to the FDA and provide its financial data for review. This process needs to be re-run every fiscal year to ensure that the business still meets the criteria for a small business.

In other FDA-regulated product categories, such as food, drugs, and cosmetics, the definition of small business and the corresponding guidelines may vary, depending on the specific regulatory context and regulatory requirements. This article mainly describes in detail the application procedures for small medical device enterprises.

Small Business Application Process

The first thing to do is determine whether the entity is based in the United States or outside the United States. There are differences in the application process and forms submitted by domestic and foreign companies.

According to the current declaration standard for small enterprises, most medical device enterprises in China are qualified for certification. The following contents share the application process for small business for Chinese enterprises.

(1) Refer to the Small Business Application Guide

Before applying for small business qualification, enterprises should consult the guide "Medical Device User Fee Small Business Qualification and Certification " to understand the process of applying for small business certification.

(2) Get the Org ID

The Organization ID Number (Org ID) is a unique number automatically assigned by the FDA when a business applies for a paid account and is used by the FDA to interact with a business. The correctness of this number is important because the FDA uses the facility identification number to interact with facilities to ensure proper payment for medical device applications. If this number is incorrect, the FDA may delay the waiver of user fees while processing your small business certification application.

If the company is already registered with the FDA, it already has an Org ID and must not create a new one. If you are not clear or forget the Org ID of the company, you can check it on the FDA website.

For instructions on how to obtain or retrieve an Org ID, see the FDA User Fee System (UFS) Account Creation Desk Guide.

(3) Download and complete Form 3602A

FDA Form 3602A is specifically for non-U.S. businesses. Companies are required to complete FDA Form 3602A Parts I and II, which focus on company information and subsidiary company information.

(4) Stamped by the local taxing authority

After completing Part I and Part II of the form, you need to go to the local tax office of the enterprise to apply for the official seal of Part III of the English original. This step requires the relevant financial personnel of the enterprise to carry the form to the lobby of the local tax bureau for consultation, and the difficulty is related to specific local policies.

(5) Submit forms and information

Mail the completed FDA Form 3602A and related tax documents to the FDA after obtaining the documents with the official seal of the taxing authority. The address is:

FY 20_ MDUFA Small Business Qualification

Small Business Certification Program

10903 New Hampshire Avenue

Building 66, Room 5305

Silver Spring, MD 20993

U.S.A.

FDA will complete its review of the small business accreditation request, including FDA Form 3602A and supporting evidence, within 60 calendar days of receipt of the application. After the FDA review is complete, it sends a letter to the business indicating whether it qualifies as a small business. Eligible small businesses are qualified to apply for reduced or waived fees during that fiscal year.

(6) Get a small business number

The FDA's decision letter also assigns a Small Business Decision Number to a small business that receives qualification approval. This number will be used in the subsequent User Fee billing application.

Validity and Cost of Small Business Certification

Small business certification is awarded for the length of a fiscal year, and expires at the end of the fiscal year. The FDA began accepting applications for small business certification for the next fiscal year on August 1.

The FDA will accept status applications for fiscal year 2024 between August 1, 2023, and September 30, 2024. Small business certification expires on September 30 of the approved fiscal year. For example, being certified as a small business on October 28, 2023 is valid until September 30, 2024.

The FDA does not charge any fees for small business certification applications. However, after the small business qualification is recognized, it is still required to pay the FDA's annual registration official fee. Business registration fees are not covered by the small business fee waiver. The business registration fee for fiscal year 2024 is $7,653.

Proregulations is committed to helping medical device enterprises complete a small business application in order to reduce the relevant registration fees. Contact us to discuss your needs, and how we can make full use of the FDA's preferential policies.