welcome central advisory system - iso consultancy singapore & malaysia
welcome to central advisory system about central advisory system central advisory system value central advisory system services central advisory system customers central advisory system achievements enquiry to central advisory system contact central advisory system central advisory system sitemap
Login to Central Advisory System Email Server
ISO 9001
ISO 14001
ISO 45001
ISO 22000
ISO 13485
ISO 17025
TS 16949
  Click for more..


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.

FDA 510(k) Legal and Statutory Consultancy

FPrinsip Mahir helps medical device companies to get their products into the US market. One of the first steps for medical device companies who manufacture Class 2 device (for which a predicate device exists) is to file a Pre-market Notification with the Food and Drug Administration, also known as a FDA 510k application.

Our FDA 510(k) submission and preparation services include: -

  • Research and review similar predicate devices already legally marketed in the US
  • Contact the FDA Office of Device Evaluation to determine any requirements for their review of this product
  • Assist in the preparation of the FDA 510 (k) submission
  • Submit the FDA 510(k) application (or amendment) to the FDA
  • Assist with the preparation of a response if the FDA has questions or requires additional information
  • Act as official correspondent on the application and remain accessible to the FDA for future discussions regarding the 510k submission
  • Monitor the progress of the FDA 510 (k) through the FDA review process and supply you with periodic updates
  • Prepare the Safety and Efficiency summary
  • Provide unlimited phone consultation during the FDA 510(k) application project

Who must submit a FDA 510(k) Pre-market Notification?

  • Manufacturers or importer/exporters introducing a new device (with predicate device) to the US market.
  • Manufacturers introducing a new finished device to the US market. If you manufacturer a component, you do not need to file a FDA 510(k) unless the component is also sold as a replacement part.
  • Specification developers that design a device and have it manufactured by another company for eventual sale in the US.
  • Companies that are proposing a significantly different design or different Intended Use for a product that is already sold in the US.
  • Repackagers or relabelers of devices. However, this only applies is you are significantly changing labels, manuals, warnings, instructions, etc.

Let Prinsip Mahir's team of experienced medical device professionals assist you in the preparation of your FDA 510(k).



  Link to Food Vigilance News
  Asia Pacific
  Click for more..



Copyright 2008 - 2009 Central Advisory System Sdn Bhd (781111-P). All Rights Reserved. Best viewed at 1024 x 768 resolution with IE 5.x.