Compliance to Standards

Compliance with Food and Drug Administration (FDA) recognized consensus standards could reduce the amount of information submitted in a 510(k) pre market notification submission. The reduced information may allow a quicker FDA review of the pre market submission. Reference to FDA recognized consensus standards are found at the following site:

Many medical device manufactures have demonstrated compliance to the Medical Device Directive, Essential Requirements by application of Harmonized Standards. Harmonized Standards undergo revisions. When a new revision is released a transition period for compliance is defined. The following standards and the end of the transition period, which is the in force effective date, are provided:

A list of Medical Device Directive Harmonized Standards can be found at the following site:

For support with standard compliance and interpretation contact:

Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589

Phone: 608 877-2635
Fax: 608 873-7382

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Updated: May 7, 2003