Medical Innovation Exchange

05-Quality/Regulatory

FDA Medical Device Sterilization Town Hall Series Continues April 29

FDA Medical Device Sterilization Town Hall Series Continues April 29     As part of its efforts to work with the medical device community on device sterilization alternatives in light of new EPA standards for ethylene oxide (EtO) emissions, the FDA is hosting a virtual town hall on April 29, 2024, from 1:00pm-2:00pm ET. The town …

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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines     On April 9, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America (“Philips Respironics”), Respironics California, Philips Holding USA, and Roy Jakobs, CEO of Royal Philips, along with …

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FDA to Host Virtual Workshop on ASCA Program Expansion

FDA to Host Virtual Workshop on ASCA Program Expansion     The FDA has announced a virtual public workshop on April 17 from 11:00am – 1:00pm ET to discuss approaches to expand the Accreditation Scheme for Conformity Assessment (ASCA) program. The ASCA program is designed to streamline conformity assessment aspects of medical device review. Currently, ASCA-eligible …

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From Concept to Market: The Strategic Journey from IND to NDA

From Concept to Market: The Strategic Journey from IND to NDA     Drug discovery and development is a complex, multifaceted process that can be challenging to navigate. The primary goal is to ensure that new therapies are safe and effective for patient use. The process includes several critical stages, each governed by strict regulatory oversight …

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IQ OQ PQ and Its Role in Labeling System Validation

IQ OQ PQ and Its Role in Labeling System Validation     In highly regulated industries including medical device manufacturing, pharmaceuticals, and life sciences, regulatory authorities such as the FDA and the European Union (EU) have guidelines related to process validation to confirm a company’s processes will result in reliable outputs and meet all necessary quality …

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Navigating the New Normal: Achieving R&D Success in Hybrid Work Environments

Navigating the New Normal: Achieving R&D Success in Hybrid Work Environments     Our office culture is transforming, driven by a convergence of technological innovation and evolving generational workforce expectations. In this new era of distributed teams and remote work models, the traditional 9-to-5 office routine is giving way to a more fluid, dynamic hybrid work …

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FDA Proposes Ban on Electrical Stimulation Devices

FDA Proposes Ban on Electrical Stimulation Devices     The FDA has proposed to ban electrical stimulation devices (ESDs) intended for self-injurious or aggressive behavior due to unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling. This is the second time the FDA has proposed …

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Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks

Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks     The FDA announced that Abiomed is updating the instructions for use (IFU) of its Impella Left Sided Blood Pumps because the pump catheter may perforate the wall of the left ventricle in the heart. During operations, the Impella device could cut through the …

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FDA Outlines its Approach to Artificial Intelligence Regulation

FDA Outlines its Approach to Artificial Intelligence Regulation     U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how the agency’s medical product …

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EPA Issues Final Rule on Ethylene Oxide Emissions

EPA Issues Final Rule on Ethylene Oxide Emissions     On March 14, the U.S. Environmental Protection Agency (EPA) announced its final rule on ethylene oxide (EtO) emissions. The rule is intended to reduce lifetime cancer risks for people living near commercial sterilization facilities. The EPA estimates that implementation of the new regulations will reduce EtO …

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