Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

Unintended Con$equences Of FDA Form 483s
Unintended Con$equences Of FDA Form 483s

I talked with Sandra Maddock, president and CEO of IMARC Research, about trends in clinical research for medical devices, and she opened my eyes to a few very sticky situations with the FDA.

  • 4 Early-Stage Relationships Vital To Medtech Development
    4 Early-Stage Relationships Vital To Medtech Development

    This article is the first in a series exploring some of the important relationships involved in each phase of medical device development. We'll begin by looking at key relationships during the concept (or conceptual) development phase.

  • MACRA, Non-Adherence Shaping Medtech Reimbursement — For Now
    MACRA, Non-Adherence Shaping Medtech Reimbursement — For Now

    The Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 established the Quality Payment Model, starting this year. MACRA has been touted as a guide for leading the development of new devices, but can it survive patient non-adherence, spurred by better access to information, and the proposed American Health Care Act?

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WHITE PAPERS & CASE STUDIES

  • Is Your Medical Silicone Molding Company FDA Ready?

    In recent years the U.S. Food and Drug Administration (FDA) and the European Commission (EC) have increased their surveillance on medical device manufacturers and their suppliers. This article discusses how to evaluate audit readiness for a medical silicone molding company, as well as preparing to move toward global quality standards.

  • Barcoding Standards And The Search For A UDI “Easy Button”
    Barcoding Standards And The Search For A UDI “Easy Button”

    As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”  

  • 7 Considerations For More Effective Medical Device Labeling And Overlays

    Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.

  • 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets
    3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

  • The Building Blocks Of A Successful Drug Delivery Device
    The Building Blocks Of A Successful Drug Delivery Device

    Creating a successful drug delivery device requires the seamless integration of the biological or pharmaceutical regulatory requirements with the device regulatory requirements. There are several factors that need to be considered in order to do this, all while ensuring the patient is kept at the center of the design.

  • The First Step To Navigating Your Combination Product’s Regulatory Pathway:  PMOA
    The First Step To Navigating Your Combination Product’s Regulatory Pathway: PMOA

    The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.

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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 an 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, which indicate 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 recently decreed that all medical devices must 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. For example, countries in the European Union all recognize CE-Mark approval, while the regulatory framework applicable to imported devices still is being built in growth markets like China and India.

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

  • Intuitive Surgical’s da Vinci X System Gains CE Mark Approval

    Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe.

  • Allergan Gets FDA OK To Market Neurostimulator That Temporarily Increases Tear Production

    Allergan plc, (NYSE: AGN) today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.Allergan plc, (NYSE: AGN) today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.

  • FDA Clears Cardiac Insight’s Wearable ECG Sensor

    Cardiac Insight, a U.S. developer of body worn sensing devices and computational software, announced recently, the FDA has cleared the company’s wearable electrocardiogram (ECG) sensor, CARDEA SOLO. The device offers physicians immediate access to improved reporting and analysis of heartbeat-to-heartbeat data.

  • FDA Clears First Cooled RF Treatment For OA Knee Pain

    American Society of Interventional Pain Physicians Annual Meeting, Booth #407 -- Halyard Health (NYSE: HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the U.S. Food and Drug Administration (FDA) has cleared for marketing its COOLIEF* Cooled Radiofrequency (Cooled RF) thermal treatment for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA).

  • Life Spine’s Cervical Spacer System Gains FDA Clearance

    Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) market clearance to the PLATEAU-C Ti Cervical Spacer System.

  • Edwards Lifesciences' Hemodynamic Monitoring Platform Cleared By FDA

    Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, has received FDA clearance for its HemoSphere advanced monitoring platform.

  • J&J’s Ethicon Gains FDA Clearance For Echelon Circular Powered Stapler

    The circular anastomosis is one of the most critical steps in cancer surgery and has a high risk for complications. Complications can include leaks and bleeding which can require reoperation

  • Monitored Therapeutics’ GoSpiro Is First FDA-Cleared Connected, Full Home Use Spirometer

    Monitored Therapeutics, Inc. (MTI), an emerging best-in-class remote patient management company, has received FDA 510(k) clearance for its GoSpiro® Home Spirometer.

  • FDA Releases List Of Class I Medical Devices Exempt From 510(k) Notifications

    The FDA has compiled a list of over 70 class I medical devices that will no longer be subject to premarket notification requirements, effective immediately. 

  • FDA Clears Ventec's Five-In-One Portable Respiratory Device

    The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Ventec Life Systems' VOCSN, a portable respiratory system that combines five separate medical devices — a ventilator, oxygen concentrator, cough assist system, suction, and nebulizer.

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