Medical device FDA 510 (k) registration is commonly referred to as 510 (k) registration due to its corresponding FD&C Act Section 510. 510 (k) is one of the main ways for medical devices to be listed in the United States, and the vast majority of Class II medical devices and local Class I and III medical devices go through this process
The route is clear and open to the city. The FDA has a fundamental request for the necessary information to be included in the registration documents for FDA 510K certification, which roughly includes the following 16 aspects:
1) Application letter, which should include the fundamental information of the applicant (or contact person) and the enterprise, the purpose of submitting the 510 (k), the title, model, and classification materials of the device being applied for marketing, the title and 510 (k) number of the Predicte Device that has stopped essential equivalence comparison;
2) Catalog, which is a list of all materials included in the FDA510K certification document (including attachments);
3) Authenticity assurance statement, for which the FDA has a standardized sample;
4) Equipment titles, including product generic name, FDA classification name, and product trade name;
5) Registration number, if the enterprise has stopped registering when submitting 510 (k), registration information should be provided, and if not registered, it should also be indicated;
6) Classification refers to the product's classification group, category, management number, and product code;
7) Performance specifications, mandatory or voluntary specifications that the product meets;
8) Product labeling, including enterprise packaging labeling, usage instructions, packaging accessories, product labeling, etc;
9) Essential equivalence comparison (SE);
10) FDA510K certification abstract or declaration;
11) Product description, including expected use, working principle, power source, components, photos, process drawings, assembly drawings, structural representation diagrams, etc;
12) The safety and effectiveness of the product, including various design and testing materials;
13) Biocompatibility;
14) Color additives (if applicable);
15) Software certification (if applicable);
16) Sterilization (if applicable), including description of sterilization methods, sterilization certification product packaging and labeling, etc.
Medical Ding Jing Glove FDA510K Process
Essential equality comparison (SE)
The essential equivalence comparison is to prove that the product applied for listing is essentially equivalent in terms of safety and effectiveness compared to products that have been legally sold in the US market. Choosing the appropriate product to stop comparing is a key step in the 510 (K) application. When stopping the comparison, one should
Stop thinking from the following aspects:
Enterprises must provide sufficient materials to prove that the device applied for listing and the compared device are essentially equivalent (SE), otherwise the 510 (k) application will not be approved.
FDA510K Certification Inspection Procedure
After receiving the 510 (k) materials submitted by the enterprise, the FDA first checks whether the materials are complete. If the materials are complete, the FDA accepts and issues a confirmation to the enterprise, and provides the application acceptance number (K YYXXXX), which will also serve as the official approval number; If it is not complete, the enterprise is requested to supplement it within the specified time. Otherwise, it will be deemed that the enterprise has abandoned the disposal. After accepting the application, the FDA enters its internal work process, which may also request companies to provide additional materials. After the review of the 510 (k) application, the FDA does not immediately issue an approval letter. Instead, based on the product risk level, whether the market has previously had adverse reactions to the enterprise, etc., it is certain whether the on-site GMP assessment of the enterprise can be stopped. After the assessment is completed, a formal approval letter (Clearance) will be sent to the enterprise; If on-site GMP assessment is not required, a formal approval letter will be sent immediately after the 510 (k) application is approved.
The characteristics of the FDA510K certification application project are high cost, long cycle, and high difficulty. To quickly obtain approval, actively understand FDA guidelines, identify testing standards, and plan inspections
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