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Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA Staff.

The FDA released this guidance document is to provide guidance to ODE reviewers and industry on the recognition and use of national and international consensus standards, including declarations of conformity to these standards, during the evaluation of pre-market submissions for medical devices.

The FDA feels that these are issues that the have to addressed before your device can be marketed. The Center believes that conformance with recognized consensus standards can provide a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.

However, conformance with recognized standards in and of itself, may not always be a sufficient basis for regulatory decisions. For example, a specific service may raise a safety or effectiveness issue not addressed by any recognized consensus standard or a specific FDA regulation may require additional information beyond what conformity to the recognized consensus standard provides.

This FDA guidance document goes on to explain how the recognized standards should be used as well as the limitations of the standards.

Please be aware that a list of recognized standards is maintained on the CDRH website and is updated at least annually. Documentation of the CDRH internal procedures for adding/removing standards to/from the list is also maintained there. In additional to these documents, the website contains Supplemental Information Sheets which, among other things, identifies some or most types of devices to which each standard would ordinarily to expect to apply.

The FDA goes on to state that Reviewers should note that manufacturers have the right to make a declaration of conformity to a listed standard even if its device is not listed in the supplemental information sheet.

For more information on this guidance document go to the FDA website at www.fda.gov/cdrh/ost/guidance/321.html .

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