1.1 Introduction to FDA

FDA is English FOOD AND DRUG ADMIN STRATION referred to, the Chinese full name as the US Food and Drug Administration. Regulatory products include food, pharmaceuticals, medical devices, biological products, feed and veterinary drugs, cosmetics and electronic radiation products. At the international level, the FDA is recognized as one of the world's largest food and drug administration agencies. Many other countries are promoting and monitoring the safety of their products by seeking and receiving FDA help.

1.2 Regulatory medical equipment FDA subsidiary body

CDRH is a subsidiary of the FDA, full name Center for Device and Radiological Health (medical equipment and radiation health center), the main responsibilities are:

To ensure the safety and effectiveness of medical devices

Supervision of medical equipment has been marketed

Ensure that the radiation products meet the radiation safety standards

1.3 product registration process

According to the intended use of the device and the use of methods for product classification, FDA for the product has a fixed classification. Classification can determine the level of regulatory control, product classification can determine the listing route (510 (k), PMA or exempt). Products must comply with all FDA regulations before they can be sold legally in the US market.

For example: the registration process of bone plate:

Pre-IPO Notification (510 (k))

Registered

Product list

Quality System Regulation

FDA regulations

2．1  Introduction to FDA regulations

Federal Food, Drug and Cosmetic Act

The Medical Device Amendments of 1976

21 CFR xxx (code of Federal Regluation)

Medical Device User Fees and 2002 Modernization Act (MDUFMA)

Medical Device User Fees 2007 Amendment

2.2 Regulatory requirements related to medical devices

Unless it is exempted, it requires prior notice (510 (k)) or pre-market license (PMA).

Registered

Product list

Logo requirements

Quality System Regulations (21 CFR 820)

Medical Device Report (MDR) - Postmarketing System

Introduction to FDA510 (k)

What is 510 (k)?

510 (k) is a pre-market technical document submitted to the US FDA before the product enters the US market. Its role is to prove that the product with the US market on the sale of similar products with the same security and effectiveness, known as the SE (Substantially Equicalent).

Full equivalence is not exactly the same. Fully equivalent elements: intended use, design, use or transmission of energy, material, performance, safety, effectiveness, labeling, biocompatibility, performance standards, and other applicable characteristics.

When do I need 510 (k)?

Submission of 510 (k) in the following cases:

1) the first commercial distribution (listing).

Anyone who wants to sell medical devices in the United States requires a 510 (k) application at least 90 days prior to listing the device.

2) for the use of listed equipment for different purposes.

510 (k) Specification (21 CFR 807) In particular, a notice of pre-IPO is required for major changes in the purpose of use.

3) The listed equipment has changed or improved if this change can seriously affect the safety or effectiveness of the device. The use of existing equipment to significantly affect the safety or effectiveness of the equipment changes or changes, or guide the listing of equipment for the new, or with the original circumstances, the request to submit a new, complete 510 (k) file.

Medical Device 510 (k) Application Documents:

For the information that must be included in the 510 (K) file, the FDA has a basic requirement that is roughly as follows:

1) application letter, this part should include the applicant (or contact person) and the basic information of the enterprise, 510 (K) to submit the purpose of applying for the name of the listed device and classification of information, the actual equivalent of the product (Predicate Device ) Name and its 510 (K) number;

2), that is, the list of all the information contained in the 510 (K) document (including the annex);

3) authenticity assurance statement, this statement, FDA has a standard sample;

4) equipment name, that is, product generic name, FDA classification name, product trade name;

5) registration number, such as the enterprise in the submission of 510 (K) has been registered business, it should be given registration information, if not registered, but also to indicate;

6) classification, that is, the product classification group, category, management number and product code;

7) performance standards, products to meet the mandatory standards or voluntary standards;

8) product identification, including enterprise packaging logo, the use of manuals, packaging accessories, product labeling, etc .;

9) Substantial Equivalence Comparison (SE) Abstract;

10) 510 (K) Summary or statement;

11) Product description, including the intended use of the product, working principle, power source, components, photos, process drawings, assembly drawings, structural drawings;

12) product safety and effectiveness, including a variety of design, test data;

13) biocompatibility;

14) Pigment additive (if applicable);

15) Software Verification (if applicable);

16) Sterilization (if applicable), including description of sterilization methods, sterilization Ver