Medical Innovation Exchange

RC – Medtech Regulatory Resource Center

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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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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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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FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data      Following what it calls an “alarming” increase in medical device submissions containing unreliable data generated by third-party test labs, the FDA has issued a letter to industry urging sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage …

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FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office     As part of its reorganization of the Center for Devices and Radiological Health (CDRH), the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office within CDRH. Launched in 2019, the OST was designed create …

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FDA To Host Town Hall on Medical Device Sterilization

FDA To Host Town Hall on Medical Device Sterilization     The FDA will host the second in a series of medical device sterilization town halls on Friday, January 26, 2024 from 12:00pm-1:00 pm ET. This session, “FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO),” will focus on the challenges and opportunities of …

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MHRA Releases Roadmap of Future UK Medical Device Regulation

MHRA Releases Roadmap of Future UK Medical Device Regulation     On January 9, The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced its plan for medical device regulation. The ‘roadmap’ for new regulations sets out a route to deliver new regulations via a series of new Statutory Instruments (SIs). The agency will put priority …

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Regulatory Advocacy: Amplifying Your Voice

Regulatory Advocacy: Amplifying Your Voice     Medical devices and pharmaceuticals are heavily regulated. In the U.S., stakeholders have opportunities to communicate with regulators through pre-submission meetings, commenting on proposed regulations and draft guidances, and working with industry trade associations. But what is the right path for your particular company or concern? During the 2023 MedTech …

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FDA Issues Updated Draft Guidance on Use of Real World Evidence

FDA Issues Updated Draft Guidance on Use of Real World Evidence     On December 18, the FDA issued a draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. When final, this guidance will supersede Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, issued August 2017. The new draft guidance …

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