U.S. FDA 510(k) Medical Device Submissions Requirements

U.S. FDA 510(k) Medical Device Submissions Can Be Complicated
Registrar Corp's team of Regulatory Advisors can provide a Free Assessment of your U.S. FDA 510(k) submissions needs. Simply click below to provide information about your device.

如你所知，很多医疗器具需要通过美国FDA审查，才可以在美国销售。要获得审查通过，企业必须提交申请材料，包括足够的科学技术资料，来证明此产品和已经在美国市场合法销售的器材有等同的资格。.

A 510(k) is the mechanism to clear your medical device for commercial distribution and allow the product to be marketed in the United States.

Most companies have the technical expertise to compile their scientific information for a 510(k) submission. However, many companies need assistance with the structure, format and verification that all required elements are included in their 510(k) prior to submission. Registrar Corp's 510(k) Administrative review provides this assistance, including:

• A review of your product user guide and labeling (to be submitted with your 510(k))

• Verification of the structure, format and required elements of your 510(k)

• Submission of your 510(k) to the U.S. FDA

• Facilitation of the U.S. FDA government fee payment

• Correspondence with the U.S. FDA on your behalf.

Registrar Corp's 510(k) Administrative Review and Submission Service can prevent incomplete submissions and costly delays. To learn if this service would be helpful for your particular submission, simply click on the link below: