Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

Brazil’s Medical Device Market: Patient Demographics, Healthcare System, And Outlook

Government initiatives, favorable demographic conditions, and increased patient purchasing power are among the factors that make Brazil an attractive medtech investment definition. Challenges are weighed against opportunities in this article, the second of a two-part series examining the Brazilian medtech market and factors that affect it.

Understanding Medical Device Regulation In Brazil

Latin America’s largest medical device market is streamlining its registration process and attempting to harmonize with globally recognized standards. Challenges are weighed against opportunities in this article, the first of a two-part series examining the Brazilian medtech market and factors that affect it.

Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19

Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance

The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

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WHITE PAPERS & CASE STUDIES

The Criticality Of Process Validation

Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.

A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

It has been reported that 83,000 deaths and 1.7 million injuries have been linked to medical devices adverse events over the past decade. There is indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations, possibly leading to medical devices that pass FDA HFE validation yet still exhibit significant use errors when utilized in the real world. This paper explores the possible sources of HFE performance problems with medical devices and links potential problems to HFE validation methodologies within the FDA HFE guidance framework.

Preparing For MDR? Start With A Gap Analysis

With the EU MDR going into effect in about a year, medical device manufacturers are gearing up to prepare product lines for the massive regulatory changes. The planning and pre-clinical testing necessary for MDR compliance can be an exhaustive, multi-faceted venture. 

Single-Touch Labeling: The Answer To EU MDR?

Warren Stacey, PRISYM ID, examines a single-source approach that could eradicate data duplication, inconsistencies, and costly human error.

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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 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.

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