FDA Recognized Consensus Standards.

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Resource Abstract:
description: <p>This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.</p>; abstract: <p>This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.</p>
Citation
Title FDA Recognized Consensus Standards.
creation  Date   2018-06-09T14:18:06.953820
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Metadata data stamp:  2018-08-07T00:13:09Z
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notes: This metadata record was generated by an xslt transformation from a dc metadata record; Transform by Stephen M. Richard, based on a transform by Damian Ulbricht. Run on 2018-08-07T00:13:09Z
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organisation Name  CINERGI Metadata catalog
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electronic Mail Address cinergi@sdsc.edu
Metadata language  eng
Metadata character set encoding:   utf8
Metadata standard for this record:  ISO 19139 Geographic Information - Metadata - Implementation Specification
standard version:  2007
Metadata record identifier:  urn:dciso:metadataabout:89f36fb2-22b3-41ac-9c1e-f05bec45b1aa

Metadata record format is ISO19139 XML (MD_Metadata)