Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

Reconditioned Devices: Potential Regulatory Changes Create Tension Between Third-Party Entities, OEMs
Reconditioned Devices: Potential Regulatory Changes Create Tension Between Third-Party Entities, OEMs

Concerns voiced in the Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers request for comments represent a situation to monitor, affecting product quality and public health issues.

  • How To Smoothly Implement A Recall
    How To Smoothly Implement A Recall

    Once a decision has been reached for removal or correction, many internal and external actions are required to implement the recall.  Manufacturers need to act with a sense of urgency and avoid further internal crises through a defined recall process.

  • Usability’s Importance In Combination Products: The Mylan Citizen Petition Case Study
    Usability’s Importance In Combination Products: The Mylan Citizen Petition Case Study

    Citizen petitions often are submitted to question or persuade FDA to examine product safety issues, but they also have been abused to prevent products from reaching market. Sharp attention to usability and human factors can give you the upper hand, though, if your company is targeted by this underhanded strategy.

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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.

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