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:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm



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:

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html



For support with standard compliance and interpretation contact:

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

E-mail: QRASupport@AOL.com
Phone: 608 877-2635
Fax: 608 873-7382

http://www.qrasupport.com

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Updated: May 7, 2003