Medical Device Regulations & Compliance


Human Factors Align At The RAPS 2017 Regulatory Convergence
Human Factors Align At The RAPS 2017 Regulatory Convergence

Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here. 

  • New CMS Payment Rates for 2018; Same Challenges for Medtech
    New CMS Payment Rates for 2018; Same Challenges for Medtech

    On Aug. 2, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare payment and polices when patients are discharged from hospitals from Oct. 1, 2017, to Sept. 30, 2018.

  • Flip The Org Chart: Rethink Where A Pharma Company's Focus Should Be
    Flip The Org Chart: Rethink Where A Pharma Company's Focus Should Be

    I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"

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  • OEMs: Do You Trust Your Medical Device Supplier’s Quality?
    OEMs: Do You Trust Your Medical Device Supplier’s Quality?

    As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. That is no easy task. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system. When it comes to evaluating the quality systems of your medical device supplier, where do you begin?

  • Managing The Unpredictability Of The Product Development Process
    Managing The Unpredictability Of The Product Development Process

    How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.

  • Incorporating Stress Into User Testing
    Incorporating Stress Into User Testing

    How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your medical device in the real world?

  • Is Your Medical Silicone Molding Company FDA Ready?

    The U.S. 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.

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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.


  • Medtronic’s Next-Gen SCS For Chronic Pain Management Approved By FDA

    Medtronic plc recently announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain.

  • NuVasive’s MAGEC Scoliosis Treatment Cleared By FDA

    NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company's redesigned MAGEC® system with its RELINE® Small Stature system.

  • Medtronic’s Attain Stability Quad MRI SureScan Active-Fixation Heart Lead Gains CE Mark

    Medtronic plc announced it has received CE (Conformité Européene) Mark for the Attain Stability Quad MRI SureScan left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead features novel, active-fixation technology that is designed for precise lead placement and stability.

  • J&J’s Ethicon Launches ProxiSure Suturing Device

    Ethicon, part of the Johnson & Johnson Medical Devices Companies, announced today the U.S. launch of the ProxiSure™ Suturing Device, an advanced laparoscopic suturing device featuring Ethicon endomechanical, suture and curved needle technologies.

  • Renovis Surgical’s 3D-Printed Posterior Lumbar Interbody Fusion Systems Cleared By FDA

    Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems.

  • GE’s SIGNA Premier 3.0 MRI Cleared By FDA

    GE Healthcare is proud to announce SIGNA Premier, a new wide bore 3.0T magnetic resonance imaging (MRI) system, is now available for sale in the U.S. SIGNA Premier is the result of a four-year collaboration with the National Football League (NFL) and research institutions around the world working to design new imaging tools, particularly to aid researchers in the detection of biomarkers for the potential diagnosis of mild Traumatic Brain Injury.

  • Medtronic’s Avalus Surgical Aortic Valve Gains FDA, CE Mark Approval

    Medtronic plc recently announced CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease.

  • Immunalysis’ Fentanyl Urine Drug Screening Test Cleared By FDA

    Immunalysis Corporation, a division of Alere Inc. (NYSE: ALR), today announced that its SEFRIA™ Fentanyl Urine Enzyme Immunoassay has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the qualitative detection of fentanyl in urine.

  • Medtronic’s CoreValve Evolut PRO TAVR Gains CE Mark, Launches In EU

    Medtronic plc recently announced CE (Conformité Européenne) mark and European launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery

  • Quantitative Insights’ QuantX Advanced Computer-Aided Diagnosis Platform Earns FDA De Novo Approval

    Quantitative Insights, Inc. (QI) recently announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantX Advanced system, the industry’s first computer-aided diagnosis platform incorporating machine learning for the evaluation of breast abnormalities.

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