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Title: Business Services/Consulting/Medical and Life Sciences/Regulatory Affairs - WellKang LLC Regulatory affairs consultancy specializing in medical devices.
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510k- FDA 510(k) Submission Procedures: Introduction - Services offered by Wellkang LLC
Wellkang® LLC
World Leading Consultancy inFDA 510(k), UL, CCC Mark, CE Marking
 
Your One-Stop Reliable Partner in International Trade!
Search:
510(k) Submission Process
Introduction
List of Official Steps:
Log-in Procedures
Division Acceptance Criteria
Reviewer Assignment
FDA Requests forAdditional Information
Administrative Review
Decision Letter Issued
510(k) Status Program
News - “US Agent” Needed
February 11, 2002:
The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.
Wellkang LLC is your reliable “US Agent” in dealing with FDA.
Introduction:
Premarket notification (PMN) submissions [510(k)]s for medical devices are reviewed and processed by the Center for Devices and Radiological Health
(CDRH) within the FDA. The Office of Device Evaluation (ODE) within CDRH is responsible for the processing and review of 510(k)s and
providing a decision related to clearance to market medical devices in the U.S.
Within ODE there are six divisions organized according to medical scientific
disciplines. Each ODE division has a scientific staff that performs scientific reviews
of 510(k)s and other research (IDE) and marketing applications (PMA). These
individuals are commonly referred to as ODE reviewers. For the most part, it
is their recommendation that determines whether a new device is substantially
equivalent (SE) or not substantially equivalent (NSE). The following is a description
of how 510(k)s are processed and reviewed by ODE and the 510(k) programs that
affect this process.
Click here to continue...
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