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FDA认证注册列明,上市前通知510K是什么概念并如何建立510K相关文件

来源:本站 作者:深圳市肯达信企业管理顾问有限公司 陈小姐 18575592846 发布时间:2020-07-31

Premarket Notification 510(k)

Introduction

What is Substantial Equivalence

Who is Required to Submit a 510(k)

When a 510(k) is Required

When a 510(k) is not Required

Preamendment Devices

Third Party Review Program

Please note: FDA charges a fee for review of Premarket Notifications [510(k)]

Introduction

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution (see The 510(k) Program Guidance).


A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found SE through the 510(k) process, or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act that is not exempt from premarket notification requirements. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. . Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.


Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.


Please note that FDA does not typically perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.


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What is Substantial Equivalence

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate.


A device is substantially equivalent if, in comparison to a predicate it:


has the same intended use as the predicate; and

has the same technological characteristics as the predicate;

or

has the same intended use as the predicate; and

has different technological characteristics and does not raise different questions of safety and effectiveness; and

the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices needs to be identical. FDA first establishes that the new and predicate devices have the same intended use and any differences in technological characteristics do not raise different questions of safety and effectiveness. FDA then determines whether the device is as safe and effective as the predicate device by reviewing the scientific methods used to evaluate differences in technological characteristics and performance data. This performance data can include clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility evaluation, among other data.


A device may not be marketed in the U.S. until the submitter receives a letter finding the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:


resubmit another 510(k) with new data,

request a Class I or II designation through the De Novo Classification process

file a reclassification petition, or

submit a premarket approval application (PMA).

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Who is Required to Submit a 510(k)

The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.


The following four categories of parties must submit a 510(k) to the FDA:


Domestic manufacturers introducing a device to the U.S. market;


Finished device manufacturers must submit a 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices. However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts. Contract manufacturers, those firms that manufacture devices under contract according to someone else's specifications, are not required to submit a 510(k).

Specification developers introducing a device to the U.S. market;


A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.

Repackers or relabelers who make labeling changes or whose operations significantly affect the device.


Repackagers or relabelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).

Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510(k). Additional information is found on the webpage "Is a new 510(k) required for a modification to the device?"


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