EPPGEnvironmentally Preferable Purchasing Guide
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The agency said recent data show that the EPPG, together with the recommended special controls, provides reasonable assurance of its safety and effectiveness.
The agency said supporting evidence to reclassify EPPG devices includes a low reporting of serious adverse events to the FDA's Manufacturer and User Facility Device Experience database, as well as a low rate of postmarket recalls.
In order to prepare for these changes, EPPG Operations Services formed teams to respond to the proposed rulemaking and to develop the Integrity Management Program based upon the final rule.