Medical Device Regulations & Compliance
INDUSTRY PERSPECTIVES
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![Risk-Benefit-reward-GettyImages-1264804060]( "EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused")
EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-FocusedThe EU's Medical Device Regulation refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in the safety profiles of products.
The proposed revision to the U.S. Quality System Regulation (aka 21 CFR Part 820) takes a giant leap toward harmonization with other major global medical device regulations, but some U.S.-specific terms and requirements will remain in effect. This article shares the details and also discusses the impact on inspections.
Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.
This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time.
With a population of 32 million, Peru is the fifth most populous country in Latin America. Its medical device market is $390 million, and it imports more than 97% of the medical devices that it uses. This article covers Peru's health system, its medical device regulatory framework, and opportunities for medical device imports.
WHITE PAPERS & CASE STUDIES
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![inspection]( "The Search For Control: Total Quality In Life Sciences")
The Search For Control: Total Quality In Life SciencesBring data into one place to gain end-to-end visibility and traceability for total quality in every stage of research, development and manufacturing.
Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.
Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.
The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.
In medical device development, speed, efficiency, and accuracy with document control processes are a top priority. Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.
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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Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark2/15/2018
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
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Arterys’ Oncology Imaging Suite With Deep Learning Cleared By FDA2/15/2018
Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, recently announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA).
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Embrace Becomes First FDA-Cleared Seizure-Monitoring Smart Watch2/5/2018
Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.
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FDA Clears Zimmer Biomet’s Total Shoulder Arthroplasty System1/3/2018
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.
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K2M’s 3D-Printed Expandable Corpectomy Cage With Cervical Spine Indications Gains CE Mark12/20/2017
K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case.
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First Wire-Free Radar Breast Tumor Localization System For Long-Term Implant Cleared By FDA11/13/2017
Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization.
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CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark10/27/2017
CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).
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Acutus Medical’s Real-Time Cardiac Mapping Systems Cleared By FDA10/24/2017
Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed.
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FDA Clears Game Ready’s Multi-Modality Recovery Device10/6/2017
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.
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FDA Approves Implantable To Treat Central Sleep Apnea10/6/2017
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea.