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Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines

Medical device manufacturers producing devices that involve patient contact are required to perform biological safety evaluations, which may include the need for biocompatibility tests to ensure patient safety, as specified by ISO 10993. On June 16, 2016, the U.S. Food & Drug Administration (FDA) expanded and clarified how manufacturers should comply with the ISO 10993-1 … Continued

MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden

The approval of the new European (EU) Medical Device Directive (MDR) and EU In Vitro Diagnostic Regulation (IVDR) on April 5, 2017 by the EU Parliament in Strasburg, France has prompted the implementation phase of this new and significant legislation. Its legal debut entitled, “Entry into Force,” follows 20 days after publication in the European … Continued

Why Regional Reimbursement Strategies Could Be Right For Medtech

Originally published in Medical Device & Outsourcing, a MassDevice Resource The medtech space is facing increasing challenges, particularly in the reimbursement space. Although the process is difficult, device makers may find that regional reimbursement strategies better suit their immediate needs to get products to market, according to experts at NAMSA. Let’s start with the challenges. … Continued

FDA Clarifies Policy for Color Additives in Medical Devices

On February 12, 2016, the U.S. Food and Drug Administration (FDA) held a webinar to clarify their current policy in relation to the use of color additives in medical devices. Under Chapter VII, section 721 of the Federal Food, Drug, and Cosmetic, color additives are subject to FDA approval before they may be used in … Continued