The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the submission of premarket notifications for Magnetic Resonance Diagnostic Devices (MRDD) intended to be marketed and used in the country.
The document provides an overview of the applicable regulatory requirements based on the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
Regulatory Background
The present guidance document provides specifications for the information to be included in a premarket notification for MRDDs.
Its purpose is to harmonize with the 4th edition of the FDA-recognized standard, IEC 60601-2-33, which concerns medical electrical equipment.
Specifically, it addresses the redefinition of the main magnetic field (B0) hazard area from 0.5 mT in prior versions to 0.9 mT in the current edition.
The authority additionally emphasises that submissions related to this standard should be accompanied by the appropriate documentation.
Additionally, MRDDs are governed by the Electronic Product Radiation Control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are subject to radiological health requirements.
Scope
As further explained by the FDA, MRDDs are defined under 21 CFR 892.1000 as devices used for general diagnostic purposes, capturing images and magnetic resonance spectra.
They include a range of imaging and spectroscopy techniques such as hydrogen-1 (proton) imaging and phosphorus-31 spectroscopy.
Classified as Class II medical devices, MRDDs require premarket notification and an FDA determination of substantial equivalence to a similar device already placed on the market (predicate) before they can be marketed.
The devices are identified under three product codes: LNH, LNI, and MOS.
The main components of an MRDD include such elements as the main magnet, power supplies, computer systems, and patient supports.
This guidance applies to premarket notifications for MRI and MRS systems, their components, and accessories.
It also covers modifications to these systems which might significantly impact the safety or effectiveness of the MRDD.
Additionally, the guidance is relevant for MRI system components of dual-modality devices like PET/MRI systems.
Relevant Standards
The document pays special attention to the applicable standard the responsible parties may refer to. According to the guidance, MRDD 510(k) submissions may use standards when they are applicable.
NEMA Standards. The National Electrical Manufacturers Association (NEMA) offers standardized test methods for evaluating MRDDs.
While these standards prescribe measurement methods, they don’t specify acceptance criteria. Some recognized NEMA test methods include:
- MS 1: Determining Signal-to-Noise Ratio (SNR) in MR Images
- MS 4: Measuring Acoustic Noise in MRI Devices
- MS 8: Characterizing Specific Absorption Rate (SAR) for MRI Systems
- MS 12: Mapping of Geometric Distortion for Special Applications
This is an international standard focusing on the safety of magnetic resonance equipment meant for medical diagnosis.
It provides specifications for such equipment. Some NEMA standards, such as NEMA MS 4 and MS 8, have been integrated into IEC 60601-2-33.
However, this IEC standard does not address performance aspects, e.g., SNR and image uniformity.
Other Standards. Several other standards apply to MRDDs. These include:
- ISO 10993-1: Evaluating and Testing patient-contacting materials in MRDDs within a Risk Management Process.
- NEMA PS 3.1 – 3.20: Standardizing formats for the digital exchange of medical images.
- ANSI/AAMI ES60601-1 and IEC 60601-1, addressing general requirements for the basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2, focusing on electromagnetic disturbances’ requirements and tests for medical electrical equipment.
Conclusion
In summary, this guidance is intended to assist manufacturers and stakeholders involved in the development and marketing of MRDDs in ensuring compliance with the applicable regulatory requirements.
It aligns with the latest recognized standards, ensuring that MRDDs are both safe and effective for medical diagnosis.
Manufacturers should follow these guidelines and be aware of the relevant standards when preparing their premarket notifications.
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