Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

How Early Talks With The FDA Can Pave Your DTx Approval Pathway

Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

Making Good Decisions When FDA Investigators Come Knocking

Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

Bacterial Endotoxin Testing, Part 1: Overview

All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

Data-Driven Trends In Predetermined Change Control Plans

The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings.

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WHITE PAPERS & CASE STUDIES

Eccentric Loading Test (Eccentricity) With External Test Weights

In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.

One-Point Calibration With External Test Weights

This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.

Performance Test According To Chapter 2.1.7 Of The Ph. Eur.

This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.

Repeatability Test With External Test Weights

A repeatability test with external test weights is one of the recommended tests to ensure balances are working correctly. This operating procedure describes how to perform a repeatability test with external test weights.

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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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