Ensuring the efficiency and safety of healthcare requires cutting-edge medical devices. These devices offer numerous benefits with technological advancements and connectivity. Compliance with regulatory bodies is crucial to guaranteeing the safety and effectiveness of medical devices in their target markets.

In the United States, the FDA classifies medical devices into three categories based on risk levels: Class I, II, and III. Manufacturers must adhere to specific regulatory pathways to obtain market clearance:

1. Premarket Notification 510(k)
2. Pre-Market Approval (PMA)
3. De Novo Classification Request
4. Humanitarian Use Exemption (HDE)

At InfosecTouchpoints, we specialize in assisting software as a medical device (SAMd) manufacturers with their 510(k) clearance process. We align development processes with FDA-approved standards and regulations, ensuring a smooth approval journey.

To gain premarket clearance, medical device manufacturing companies must adhere to FDA guidelines, including internationally recognized standards, general controls, and device-specific special controls. Compliance with these guidelines is vital for demonstrating security, safety, and efficacy.

General Requirements of FD&C Act

Section 501 – Adulterated drugs and devices

Section 502 – Misbranded drugs and devices

Section 510 – Registration of producers of drugs and devices

Section 516 – General rule of banned devices

Section 518 – Notification and other remedies

Section 519 – Records and reports on devices

Section 520 – General provisions respecting control of devices intended for human use

FDA Regulations

21 CFR part 820 – Contain requirements related to quality system regulation (QSR)

21 CFR part 801 – Contain general labeling provisions

21 CFR part 11 – Contain rules for treatment of electronic records and signatures

21 CFR part 807 – Contain requirements related to registration and listing

21 CFR part 803 – Contain medical device reporting requirements

Performance Standards

ISO 14971 Medical Devices – Application of risk management to medical devices

This standard defines a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process assists manufacturers to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The risks defined are related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The requirements of this standard are applicable to all phases of the life cycle of a medical device.

ISO 62304 Medical device software – Software lifecycle processes

This standard specifies life cycle requirements for the development of medical software and software within medical devices. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. It establishes a risk-based decision model on when the use of SOUP is acceptable and defines testing requirements for software as well as SOUP to support a rationale on why such software should be used. It defines processes for software development, maintenance, configuration management and problem resolution.

ISO 13485 Medical devices — Quality management systems

It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations are involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support).

ISO 82304 Health software — Part 1: General requirements for product safety

This standard applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware. It addresses requirements for the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

ISO 62366 Medical devices — Part 1: Application of usability engineering to medical devices

This standard specifies a process to analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety. The defined Usability Engineering Process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It only identifies but does not assess or mitigate risks associated with abnormal use. It contains the related methods of risk management as applied to safety related aspects of medical device user interfaces.