Medical Device FDA Registration When to submit a 510k

MostlyClass II medical devicesThe product is exported to the United States and needs to be obtained510(k)FDA registration.

1. 510(k) Meaning:

A 510(k) document is a premarket application filed with the FDA to demonstrate that the device being applied for marketing is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).etcValence device SE (substantially equivalent)。The applicant must compare the device applied for marketing with one or more similar devices currently on the U.S. market and conclude that the device is equivalent and supportive.

2. A reference to a 510(k) must be submitted:

1. Domestic manufacturers who introduce medical devices into the U.S. market;

2. Standard-setters for the introduction of medical devices into the U.S. market;

3. Repackaging or relabeling that changes the labeling or operation seriously affects the medical device;

4. The U.S. party of the foreign manufacturer exporter or foreign manufacturer exporter who introduces medical devices into the U.S. market.

orMedical devices 510(k).For more information, please contact our company, Registrar Corp

A 510k is a medical device that must be registered for commercial sale and must submit a premarket notification at least 90 days in advance. There are three types of situations in which a 510(k) may be filed:

a. The first commercial distribution (listing).

After May 28, 1976 (the effective date of the FDA&C ACT's medical device amendments), anyone wishing to ** a medical device in the U.S. is required to file a 510(k) application at least 90 days prior to the device's market. If the device was not marketed by your company prior to May 28, 1976, a 510(k) is required.

b. Different purposes of use are proposed for marketed devices. Specification 510(k) (21 CFR 807) specifically requires the filing of a premarket notification for major changes in the purpose of use. The purpose of use is indicated in the label of the device or in the advertised statement.

However, if the intent does not change completely, most changes require a 510(k).

c. Changes or improvements to marketed devices, if the changes can seriously affect the safety or effectiveness of the device.

It is the responsibility of the applicant to determine whether the improvement is capable of significantly affecting the safety or effectiveness of the device. Whatever conclusion is reached, a record should be made that can be reflected in the master record of the device, and the control record can be changed under the requirements of the medical device quality management practice. If asked, the applicant will be able to demonstrate that the change has been evaluated.

A new, complete 510(k) document is required if changes or alterations have been made to an existing device that significantly affects the safety or efficacy of the device, or where the guidelines for the marketed device are new or different from the original. To learn more, you can go to Orshida...