Wednesday, April 28, 2010

Clinical Submission of a Premarket Notification Application / 510k

The Food, Drug and Cosmetic Act 501k requires medical device and diagnostic kit companies, manufacturers, importers and/or exporters to register their product with FDA at least 90 days prior to the intended time to market.

A question often asked by a client is...must I submit a 510k Premarket Notification Application to FDA?

Manufacturers, importers, exporters and otherwise of Class I, II, or III device and/or diagnostic kits are required by FDA to file a 510k. This includes:
  • Device or diagnostic companies, manufacturers, importers and/or exporters wishing to introduce a new device to the US market
  • Specification developers that design a device or diagnostic kit 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
  • Companies that repackage or relabel device or diagnostic kits.

There are 3 types of 510k Premarket Notification Applications:

  • Traditional 510k clinical submission
  • Abbreviated 510k clinical submission
  • Special 510k clinical submission.

Clinical submission of a Premarket Notification Application to FDA by the medical device, diagnostic kit company, manufacturer, importer, exporter or otherwise, must contain specific data and documentation, quality controlled systems, standard operating procedures, quality management plans, detailed for each type of product and its intended use.

What is the first clinical submission step when considering your Premarket Notification Application to FDA?

The first step is to determine the classification of your medical device or diagnostic kit. There are 3 classes, I, II or III with specific criteria that must be met for each class.

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