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FDA Issues Notice of Proposed Rulemaking Regarding 21 CFR Part 58, Good Laboratory Practice (GLP).

The proposed changes would affect all participants in GLP trials:  Sponsors, Testing Facilities and supporting laboratory services.  We encourage all affected parties to review and comment on the proposed changes.  The public comment period for the proposed changes closes November 22, 2016.  Details on the proposed changes and how to comment are available on the […]

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July […]

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ISO/TC 194 – Biological and Clinical Evaluation of Medical Devices

APS Staff participated in the annual gathering of Technical Committee 194 of the International Standards Organization which is responsible for the continuing development and revisions of the guidelines for “Biological and Clinical Evaluation of Medical Devices”. The output of this committee and the associated 17 working groups is critical in the global processes standardizing biological […]

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