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Summary of FDA Statement on Laboratory Developed Tests Issued January 13, 2017

On January 13, 2017, the Food and Drug Administration (FDA) issued a discussion paper on laboratory developed tests (LDT) synthesizing the regulatory dialogue that FDA and stakeholders have had since 2010 and outlining future regulatory possibilities for LDTs.  FDA and a majority of stakeholders support a complimentary approach to regulating LDTs that combines FDA’s experience … Continue Reading

FDA Issues Guidance for Classification Pathways for New Accessory Types

Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality.  Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right.    The 21st Century Cures Act, passed into law … Continue Reading

FDA Working to Modernize Medical Device Reporting in Hospitals

Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals.  FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it … Continue Reading

BREAKING: Deal Reached on New EU Medical Device and IVD Regulations

On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations.  The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … Continue Reading

FDA Considers Regulating Refurbishers and Other Third Parties

The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able … Continue Reading

FDA Announces Commitment to MDSAP

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

A Breakdown of Recent 340B Program Changes

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

HRSA issues 340B Interpretive Rule

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

FDA Shows Plans to Enforce Food Facility Registration by Issuing Draft Compliance Guidance

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
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