The FDA announced on December 17 that it would participate in the operational phase of the Medical Device Single Audit Program (MDSAP), starting January 1, 2017. The FDA currently participates in the ongoing MDSAP pilot program, scheduled to run until the end of 2016. The MDSAP program was created by the International Medical Device Regulators … Continue Reading
In a recent article, Eugenia Pierson, a Principal in Squire Patton Boggs Public Policy Health Care Practice, urged providers to prepare for HRSA’s promulgation of the 340B mega rule. In addition to safety net hospitals struggling with ACA implementation, tight state budgets, and delivery system reform, 340B issues and anticipated program changes promise to be … Continue Reading
The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) recently announced the availability of an interpretive rule (the “Interpretive Rule”) regarding section 340B(e) of the Public Health Service Act (PHSA), effective July 21, 2014. This Interpretive Rule comes on the heels of the US District Court for … Continue Reading
The U.S. Food and Drug Administration (“FDA”) recently announced the availability of draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food (the “Draft CPG”). The Draft CPG is intended to provide FDA staff with guidance on issues related to food facility registration, including the requirement that certain food facilities register with FDA, … Continue Reading
