Medical Device Regulations & Compliance
INDUSTRY PERSPECTIVES
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The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. Software-enabled medical device companies that master this tool will be able to more rapidly improve their device products.
The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical recommendations and considerations.
Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA. What can you do when the agency rejects your 510(k) or requests more information? How can a Q-Sub help? This article shares practical recommendations.
The pharma industry has invested greatly in IT systems and optimized data and content management. Medical device companies can learn from pharma's experience — and it will ease the regulatory burden.
WHITE PAPERS & CASE STUDIES
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This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the United States Pharmacopeia.
In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.
This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.
ABOUT MEDICAL DEVICE REGULATIONS & COMPLIANCE
Medical devices, from ideation to post-launch assessment, are regulated in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 and subsequent amendments to the Federal Food, Drug and Cosmetics Act of 1938.
The FDA’s medical device regulatory pathways — for premarket review, clearance, and approval — are based on three classifications, indicating the degree of regulatory control necessary to ensure a device’s safety and effectiveness. Class I devices are considered low-risk, and many are exempt from the regulatory process. Class II devices require special controls for “labeling, guidance, tracking, design, performance standards, and postmarket monitoring,” and most require premarket notification 510(k) to demonstrate substantial equivalence (having the same intended use and technological characteristics) to a legally marketed device. Class III devices usually sustain or support life, are implanted, or present a significant risk of illness or injury. Most class III devices require premarket approval (PMA), which examines a variety of factors in weighing the probable health benefits from intended use of a device versus the probable risks.
Medical device makers must adhere to Current Good Manufacturing Practice (CGMP) regulations, which FDA inspectors use to determine if a manufacturer has the facilities, skills, and equipment to produce and pack its product. In addition, the FDA requires all medical devices to carry a unique device identifier (UDI), readable by both machines and humans, to “improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”
Medical device makers competing in international markets must monitor and adhere to the policies of foreign regulatory bodies, which can vary greatly, depending on the nation. Further, many global regulators require manufacturers to be certified by the International Organization for Standardization (ISO). ISO 13485 compliance, confirmed through third-party (Notified Body) audits, demonstrates a medical device manufacturer’s procedures and products meet or exceed international quality standards.
Efforts are also underway to standardize international regulations to ensure the safety, effectiveness, and quality of medical devices. The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States — is building upon previous work by the Global Harmonization Task Force on Medical Devices (GHTF) to speed this harmonization and convergence.
LATEST HEADLINES
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Medtronic's InterStim Micro Neurostimulator, InterStim SureScan MRI Leads Gain CE Mark1/13/2020
Medtronic plc (NYSE:MDT) today announced it has received CE Mark for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads — clearing the technologies for commercial sale and clinical use in Europe.
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FDA Clears Medtronic's Stealth Autoguide System For Cranial Procedures12/18/2019
Medtronic plc (NYSE:MDT) announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution.
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Medtronic Submits InterStim Micro Neurostimulator And SureScan MRI Leads For FDA Approval10/7/2019
Medtronic plc (NYSE:MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads.
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FDA Grants Breakthrough Designation To SoniVie's TIVUS System To Treat Pulmonary Arterial Hypertension9/6/2019
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with PAH.
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Orchestra BioMed's Cardiac Neuromodulation Therapy Device For Hypertension Earns CE Mark9/4/2019
Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions.
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FDA Clears Dominion Aesthetic Technologies' Non-Contact Body Sculpting6/25/2019
Dominion Aesthetic Technologies, Inc. recently announced that it has received FDA clearance for its body contouring product, eon FR, which is a non-contact medical device that reduces fat.
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FDA Clears Itamar Medical's Fully Disposable Home Sleep Apnea Test6/6/2019
Itamar Medical Ltd. (Nasdaq:ITMR) (TASE:ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for WatchPAT One, the latest innovation of its WatchPAT technology and the first and only fully disposable Home Sleep Apnea Test (HSAT).
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FDA Approves BD's First Venous Stent To Treat Iliofemoral Venous Occlusive Disease3/14/2019
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo™ venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin.
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CurvaFix Receives FDA 510(k) Clearance For CurvaFix Rodscrew3/5/2019
CurvaFix, Inc., a developer of medical devices to repair bone fractures in orthopedic trauma patients, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CurvaFix® Intramedullary Rodscrew. CurvaFix’s patented solution has the potential to improve outcomes and enable a less invasive approach in pelvic trauma surgery.
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FDA Clears Medtronic's Accurian RF System For Nerve Tissue Ablation2/27/2019
Medtronic plc recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Accurian(TM) RF ablation platform, which conducts radio frequency (RF) ablation of nerve tissues.