FDA Compliance

Overview

In the fast-moving landscape of healthcare technology, state-of-the-art medical devices are instrumental in preventing, diagnosing, treating, and rehabilitating diseases and conditions. Advancements in technology and connectivity have empowered these devices with enhanced capabilities, promoting safer and more effective healthcare solutions.

Nevertheless, ongoing innovation brings with it the responsibility for rigorous regulatory oversight—ensuring medical device safety, security, and performance. In the United States, the Food and Drug Administration (FDA) serves as the chief authority, regulating and verifying safety and efficacy for all medical devices throughout their lifecycle.

Understanding FDA Regulatory Pathways

The FDA classifies medical devices as Class I, II, or III depending on their associated risk and required regulatory controls. Manufacturers must traverse several regulatory pathways to bring products to market:

• Premarket Notification 510(k): For devices considered “substantially equivalent” to existing, legally marketed products (predicate devices). Primarily applies to Class II and some Class I devices.
• Pre-Market Approval (PMA): Designated for Class III devices; requires comprehensive scientific evidence of safety and effectiveness.
• De Novo Classification Request: For new, innovative devices with no predicate, establishing classification and regulatory prerequisites.
• Humanitarian Use Exemption (HDE): For Class III devices designed to support patients with rare diseases or unique conditions.

Qubion Tech: Your Partner in Regulatory Compliance

At Qubion Tech, we guide medical device manufacturers—especially those developing Software as a Medical Device (SaMD)—through the maze of regulatory complexities. Our specialists streamline the 510(k) clearance process by aligning your development with FDA-endorsed standards and regulations.

Our Services

• Device Classification: Accurate risk-based device classification that ensures the correct regulatory pathway.
• Regulatory Controls Identification: Application of FDA regulatory controls and guidance documents specific to each device.
• Quality Management System (QMS) Establishment: Development of QMS and risk management processes to guarantee product quality, safety, and performance.
• Software Development Lifecycle (SDLC) Implementation: Secure SDLC integration to meet regulatory standards for medical software.
• Cybersecurity Assurance: Validation of design controls, plus comprehensive cyber testing (penetration, vulnerability, robustness).
• Documentation Preparation: Assistance with preparing required cybersecurity documentation for regulatory submissions.

Essential Guidelines and Standards

Compliance with FDA regulations and globally recognized standards is vital for confirming the safety, security, and efficacy of medical devices. Below are core requirements for most SaMD manufacturers:

FDA Regulations

• FD&C Act General Requirements: Compliance with requirements regarding adulteration, misbranding, registration, recordkeeping, and reporting.
• 21 CFR Part 820: Quality System Regulation (QSR).
• 21 CFR Part 801: General labeling guidelines.
• 21 CFR Part 11: Electronic records and signatures requirements.
• 21 CFR Part 807: Registration and listing rules.
• 21 CFR Part 803: Medical device reporting standards.

Performance Standards

• ISO 14971: Risk management for medical devices, including SaMD. Applicable throughout the device lifecycle, covering hazards such as biocompatibility, data security, and usability.
• ISO 62304: Software lifecycle requirements for medical device development, maintenance, and configuration management, utilizing a risk-based approach.
• ISO 13485: Quality management systems specification for medical devices, supporting regulatory compliance across all lifecycle stages.
• ISO 82304: Product safety standards for health software operating on general computing platforms.
• ISO 62366: Usability engineering for medical devices, focusing on processes to minimize risk during normal use.

Why Expertise Matters

Successfully navigating the regulatory environment for medical devices, particularly SaMD, requires specialized knowledge and diligence. Qubion Tech offers end-to-end FDA compliance support, ensuring your solutions meet both U.S. and international standards to enable rapid market introduction of safe and effective products.

A thorough Vulnerability Assessment is essential to fortify your organization’s digital infrastructure. By exposing security gaps and potential cyber threats, companies can proactively address weaknesses—making informed decisions on cybersecurity investments and resource allocation.

Contact Us

For inquiries regarding regulatory compliance, clearance, or implementation of FDA standards such as 21 CFR and ISO 13485, reach out to Qubion Tech. Our consultants are prepared to help you achieve regulatory approval and market success.

Contact us today.