In order to sell medical devices in the United States, manufacturers must pass one of two evaluation processes: pre-marketing notification [5 10(k)] (if the exemption from 5 10(k) is not obtained) or pre-marketing approval (PMA). Most commercial medical devices in the United States are approved in the form of pre-marketing announcements [5 10(k)]. In some cases, it is not necessary to submit 5 10(k) or PMA for bills legally listed before May 28th 1976.
Document 5 10(k) is a pre-marketing application document submitted to FDA. The purpose is to prove that the devices applied for marketing are as safe and effective as the legally listed devices that are not affected by the pre-marketing approval (PMA), that is, they are essentially equivalent devices. The applicant must compare the device applied for marketing with one or more similar devices on the American market at present, and draw and support the conclusion of equivalent devices. The legally listed devices are devices that were legally listed before May 28th, 1976, or devices classified as Class II or Class I from Class III devices, or devices that are equivalent to such devices found through the procedure of 5 10(k), or devices established through automatic evaluation of the definition of Class III devices. Equivalent devices are called "predictive devices". The applicant must submit descriptive data and, if necessary, performance data to prove that the device is equivalent to the assertion device. Again, the data of 5 10(k) is the data indicating the similarity, that is, the equivalence between the new document and the predicate device.
FDA equivalent equipment
5 10(k) does not need to prove reasonable security and effectiveness like PMA, but needs to be proved by equivalent tools. Equivalent devices are new devices that are as safe and effective as assertion devices.
Compared with the predicate device, the device is regarded as equivalent if the following conditions are met:
-It has the same use purpose and the same technical performance as the prediction device; or
—It has the same purpose as the predicate device, but its technical performance is different, but it does not increase the safety and effectiveness. References prove that the device is as safe and effective as the legally listed device.
The so-called equivalent device does not mean that the new device and the predicate device must be exactly the same. Equivalent instruments refer to the purpose of use, design, energy, materials, performance, safety, effectiveness, labels, biocompatibility, standards and other applicable characteristics.
The applicant shall not put the device on the market before receiving the instruction to declare its equivalence. Once the device is determined to be equivalent, it can be listed in the United States. If the FDA determines that the device is not an equivalent device, the applicant can submit another 5 10(k) file containing new data, request reclassification, or submit a pre-marketing approval application (PMA). Usually within 90 days, according to the information submitted by the applicant, the conclusion of equivalent equipment is drawn.
Who must submit 5 10(k)
Food, medicine and cosmetics (FD&; C) The 5 10(k) of the Action Committee and 2 1 CFR 807 does not stipulate who must apply for 510 (k)-anyone can apply. However, they specified what kind of behavior, such as introducing equipment into the American market, and asked for a 5 10(k) application.
According to the specified behavior, the following 5 10(k) must be submitted to FDA:
1) domestic manufacturers that introduce instruments into the American market;
If the finished equipment manufacturer assembles the equipment according to its own specifications and goes public in the United States, it must submit 5 10(k). However, the manufacturer of instrument parts is not required to submit 5 10(k) unless these parts are sold to the end users as replacement parts. The contract manufacturer who assembles instruments according to other specifications according to the contract does not need to submit 5 10(k).
2) Specification makers who introduce equipment into the American market;
The FDA's review specification makers and review manufacturers are almost the same. The specification maker is the person who formulates the specifications of the finished equipment, but the equipment is produced by other companies according to the contract. Therefore, the specification maker rather than the contract manufacturer needs to submit 5 10(k).
3) The repackaging or relabeling of the instrument is seriously affected by changing the label or operation;
If the repackager or relabeler seriously changes the label or other conditions affecting the device, it may be required to submit a pre-marketing notice. At this point, you must determine whether the label has changed significantly by modifying the guide, deleting or adding warnings, contraindications, etc. And whether the packing operation can change the conditions of the instrument. However, most repackers or relabelers do not require the submission of 5 10(k).
4) Foreign manufacturers/exporters or American agents of foreign manufacturers/exporters who introduce equipment into the American market.
When do you need 5 10(k)
5 10(k) needs to be submitted in the following cases:
1) Initial commercial offering (listing). After May 28th1976 (FD&; ACT) Effective date of medical device revision), anyone who wants to sell medical devices in the United States needs to submit an application for 5 10(k) at least 90 days before the device goes on the market. If your company does not list the equipment before May 28th 1976, you are required to submit 5 10(k).
2) Put forward different uses for the equipment already on the market. Specification 5 10(k) (2 1 CFR 807) specifically requires the submission of pre-marketing notice for major changes in the purpose of use. The purpose of use is indicated in the label or advertising statement of the equipment. However, if the intention of use is not completely changed, most changes need to be submitted to 5 10(k).
3) The listed equipment is changed or improved, if this change will seriously affect the safety or effectiveness of the equipment.
The applicant is responsible for deciding whether the improvement will seriously affect the safety or effectiveness of the equipment. No matter what conclusions are drawn, records should be made, which can be reflected in the master record of medical devices, and control records can be changed under the requirements of medical device quality management standards. If asked, the applicant can prove that the change has been evaluated.
If the existing instruments are changed or modified, which has a significant impact on the safety or effectiveness of the instruments, or the guide of the listed instruments is brand-new or different from the original guide, a new and complete 5 10(k) document needs to be submitted.
When is 5 10(k) not needed?
5 10(k) is not required in the following cases:
1. If the instrument manufacturer sells the unfinished instruments to other enterprises and requires further processing, including parts for assembling instruments in other enterprises, it is unnecessary to submit 5 10(k). However, if the produced parts are directly sold to the end users as replacement parts, 5 10(k) is required.
2. If the produced instruments are not put on the market or distributed commercially, 5 10(k) is not needed to evaluate or inspect the instruments. This includes clinical evaluation. If the equipment produced is used in clinical trials, it may be restricted by the Research Equipment Exemption Ordinance (IDE).
3. If the agent is the instrument produced by other companies in China, the agent does not need to submit 5 10(k). Agents can label the equipment as "distributed by ABC Company" and sell it to end users without submitting 5 10(k).
4. In most cases, if the existing label or status of the instrument has not changed significantly, the repackager or relabeler does not need to submit 5 10(k).
5. If the instrument was legally listed before May 28th, 1976, it is not necessary to submit the document 5 10(k) unless the purpose of use is improved or changed. These instruments are called "unaffected".
6. If you are an importer of foreign-made instruments, you don't need to submit 5 10(k) in the following cases:
A.5 10(k) has been submitted by a foreign manufacturer and approved for listing, or
B.5 10(k) has been submitted by the importer on behalf of foreign manufacturers and has been approved for listing. If the importer submits 5 10(k) on behalf of a foreign manufacturer, all other importers who import the same equipment from the same foreign manufacturer (5 10(k) holder) need not submit the 5 10(k) document of the equipment.
There is no need to submit 5 10(k) when some first-class or second-class equipment is listed for the first time. The specifications of the first and second types of pardon devices can be found in the medical device pardon.
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