Wednesday, April 28, 2010

Medical Device or Diagnostic Kit Class I, II, III - FDA 510K Application and Clinical Submission

A definite change in clinical development direction has taken place in the pharmaceutical industry. A shift from the clinical development of NCE drugs to the development of genomics, biologics, biomarkers is on the rise. Interest, today, is focused on the clinical development and application of medical device and diagnostic systems.

Early 2005, a marked increase in the interest of 510K applications was noted and continues to rise in 2010. The 510K approval process for medical device or diagnostic kits, when compared to that of a drug requires less time and investment funding. Medical device or diagnostic kits, may be classified as Class I, II or Class III, a 510K marketing approval is necessary to market the product in the US. Application process and approval in Europe are different. For the US, the clinical submission approval requires compliance to the CFR, Part 820 Quality System Regulations, Good Manufacturing Practices and the other applicable CFR requirements for product type and indications of use.

510K Process - Important Facts:
  • Establishment involved in the production and distribution of medical device and diagnostic kits intended for marketing or leasing in the US are required to register with the FDA. This process is know as Establishment Registration. Registration provides FDA with the location of manufacturing facilities and importers.
  • A 510K application is made to FDA to demonstrate that the medical device or diagnostic to be marketed is at least as safe and effective, substantially equivalent.
  • A 510K application requires demonstration of submission equivalence to another legally US marketed medical device or diagnostic.
  • The holder of a 510K must have design control data and documentation available for FDA review during a site inspection.
  • Any changes to medical device or diagnostic specifications or manufacturing processes must be made in accordance with 21 CFR 820 and may be subject to a new 510K.
  • FDA does not perform 510K "clearance" facility inspections.
  • The submitter may market the medical device or diagnostic immediately after 510k approval is granted.
  • The manufacturer should be prepared for an FDA "quality system" 21 CFR 820 inspection at any time after 520K approval.
  • The CE determination is usually made within 90 days and is made based on the information submitted by the submitter.
  • The FDA charges a one time fee to review the 510K application.

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