1. FDA Application Process
1.1.Business Registration
a) Business Registration Application Form
b) FDA Confirmation, Issuance of Business Serial Numbers;
1.2.Product Registration
1.2.1 Medical device products are classified into 3 categories based on the degree of safety risk:
a) Class 1 Medical Device Listing Control
b) Class 2 Market Access Approval (i.e., 510(K) Approval)
2. p>a) Class 1 Medical Device Listing Control
b) Class 2 Market Access Approval (i.e., 510(k) approval)
c) Class 3 PMA Pre-entry Approval
1.2.2 Entrusted Agents
FDA Registration and Notification Entrusted Agreements (Signed by the legal representative and stamped by the company's official seal)
1.2.3 Provide Information< /p>
a)Business license of enterprise legal person
b)Certificate of code of business legal person, certificate of registration of association legal person, etc. (copy with company's official seal)
c)Certificate of qualification or certificate of production license within the period of validity (copy with company's official seal)
d)FDA Application Form for Registration (one copy in Chinese and one copy in English, stamped with the company's official seal)
e)FDA new additional requirements for the submission of other documents (if any).
f) Company profile (time of establishment, economic performance, technical force, the main production varieties and their performance, asset status).
1.3 Payment
Registration and listing are free of charge;
510(K), PMA are required to pay according to the fee schedule published by FDA online.
1.4 Processing of Registration
Calculated after the fee, FDA 60 working days to complete the registration;
1.5 FDA website published to inform the status of the registration , 510 (K), PMA of the FDA to send another letter of approval of access.
2 Medical device 510 (K) application documents
2.1 Medical device 510 (K) documents, that is, the FDA on the PMN required documents, because of its corresponding FD&C Act section 510 (K), it is usually referred to as 510 (K) documents. The 510 (K) document must contain information, FDA has a basic requirement, its content is roughly as follows 16 aspects:
1) application letter,
2) catalog,
3) authenticity assurance statement;
4) device name;
5) registration number;
6) classification;
7) performance standards;
7) performance standards;
8) the FDA's PMN requirements. p>7) performance standards;
8) product identification, including corporate packaging identification, instruction manuals, packaging accessories, product labeling and so on.
9) Substantial Equivalence Comparison (SE)
10) 510 (K) summary or statement
11) Product description, including the intended use of the product, working principle, power source, components, photographs, process diagrams, assembly drawings, structural schematic diagrams, etc.
12) Product safety and efficacy, including a variety of design, test information<
13) biocompatibility
14) color additives (if applicable)
15) software validation (if applicable)
16) sterilization, including the description of the sterilization method, sterilization validation, product packaging and labeling, etc.
2.2.2 Comparison of homogeneity (SE)
a) Comparison of homogeneity is to demonstrate that the product applied for listing and the product already on the U.S. market are the same. The product to be marketed is substantially equivalent in terms of safety and efficacy to a product that is already legally available in the U.S. market.
b)Selecting the appropriate product for comparison is a critical step in a 510(k) application. The following considerations should be taken into account when making the comparison:
c)The company must provide sufficient information to demonstrate that the device for which it is applying to be marketed and the device being compared are substantially equivalent (SE), or the 510(K) application will not be approved.
2.3 510(K) Review Procedures
a) Upon receipt of the 510(K) information submitted by the company, FDA will firstly check whether the information is complete; if the information is complete, it will accept and issue a confirmation to the company, and at the same time, give the company an application acceptance number (K YYXXXX), which will be used as a number for the official approval; if it is incomplete, it will require the company to supplement the information within a specified period of time, otherwise, the application will be treated as an official approval number; and if it is not complete, it will be required to provide additional information within a specified period of time. If the application is not complete, the enterprise will be required to complete the application within a specified period of time, or else it will be treated as an abandonment of the enterprise.
b)After accepting the application, the FDA will enter into the internal working procedure, in which the company may also be required to add some information.
c)In the 510 (K) application through the review, the FDA does not immediately issue a letter of approval, but according to the product risk level, the market whether the previous adverse reaction to the enterprise to determine whether to carry out on-site GMP assessment of the enterprise, the assessment of the enterprise through the formal approval of the letter sent to the enterprise (Clearance);
d)If the on-site assessment of the GMP, then the 510 (K) application through the on-site GMP assessment of the enterprise. 510(K) application passed immediately after the issuance of a formal approval letter.
3. Regarding PMA
Act (515) provides that all medical devices that are not equivalent in efficacy or safety to those already on the market in 1976 are subject to the Premarket Approval (PMA) review process, and that these new or modified devices are categorized as Class III until marketing authorization is obtained. After obtaining marketing authorization, these devices will be reclassified, and some of them will be adjusted to Class I or Class II due to their lower risk, and then they can apply for marketing under the 510(k) procedure. However, after a sitting U.S. president signs the FDA Modernization Act, new devices that are not substantially equivalent to existing legally marketed medical devices may not necessarily be classified as Class III, but may be classified as Class I or Class II and be subject to the 510(k) process for pre-market notification.
Currently, Class III devices are products that support or sustain the life of a patient, or have a significant impact on human health, with side effects that may cause illness or injury, and all such devices must be cleared by the FDA before they can be sold, and the PMA application is designed to demonstrate the safety and efficacy of the device.
The PMA application does not need to be compared to existing products on the market, but must cite more complete and rigorous supporting information, in short, the PMA review focuses on product description, materials used in the manufacturing process; preclinical laboratory and animal test results; results of clinical trials with native populations; labeling and instructions for use.