The article highlights the key points related to the radiation control legal framework.
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 radiation control regulations. The document is intended to provide additional clarification and recommendations to be taken into consideration by manufacturers of diagnostic X-ray equipment and other parties involved in order to ensure compliance with the regulatory requirements set forth under the existing legal framework.
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 relevant legislation and has been agreed with the authority in advance.
General Information for Manufacturers of Diagnostic X-Ray Equipment
The relevant section of the guidance provides a detailed explanation of regulatory responsibilities and compliance requirements for manufacturers of diagnostic x-ray equipment. It outlines the FDA’s expectations, including adherence to performance standards, proper labeling, and documentation.
Commerce and Regulatory Framework
Under Section 531 of the FD&C Act (21 U.S.C. § 360hh) and 21 CFR 1000.3(d), “commerce” includes:
- Transactions between any location in a U.S. state and any location outside of it.
- Transactions entirely within the District of Columbia.
Restrictions on Non-Compliant Products
Section 538(a)(1) of the FD&C Act prohibits manufacturers from:
- Introducing or delivering non-compliant electronic products into commerce.
- Importing non-compliant electronic products into the United States.
According to the document, medical device manufacturers seeking more details on the definition of “commerce” are referred to the FDA’s Compliance Policy Guide Sec. 390.100 – Definition of “Commerce” – 21 CFR 1000.3(d).
Export Exemptions
Another important aspect addressed in the document relates to export exemptions. As it is stated by the authority, products intended solely for export are exempt from the Radiological Health Regulations if:
- The product and its shipping container are clearly labeled or tagged as intended for export.
- The product complies with all relevant standards in the destination country (21 CFR 1010.20).
Manufacturer Obligations
The FDA defines a manufacturer as any entity involved in manufacturing, assembling, or importing electronic products (21 CFR 1000.3(n)).
Manufacturers of diagnostic x-ray equipment must meet several regulatory requirements, including:
- Accidental Radiation Reporting (21 CFR 1002.20): Reporting incidents involving accidental radiation occurrences.
- Record Maintenance (21 CFR 1002.30): Keeping detailed records related to product compliance.
- Notification of Defects (21 CFR Part 1003): Informing relevant parties of product defects or compliance failures.
- Corrective Actions (21 CFR Part 1004): Conducting repurchases, repairs, or replacements of defective products.
When it comes to certification and labeling, manufacturers must:
- Certification at Delivery: Certify that the product complies with all applicable Radiological Health Regulations standards (21 CFR 1010.2(a)).
- Identification Labeling:
- Include the manufacturer’s full name and address.
- Indicate the place and month/year of manufacture (21 CFR 1010.3(a)).
- Provide permanent certification and identification labels or tags affixed to the product (21 CFR 1010.2(b), 1010.3(a)).
- Include model and serial numbers, except for high-voltage generators and beam-limiting devices integrated with tube housings (21 CFR 1020.30(e)).
Compliance for Diagnostic X-Ray Systems
Diagnostic X-ray systems often comprise components from multiple manufacturers or a single manufacturer. Ensuring compliance with performance standards depends on proper installation and final testing at the user location.
Thus, as explained by the authority, assemblers play an important role in ensuring proper operations of x-ray equipment. Additional details regarding assemblers’ duties are available in the FDA’s Assembler’s Guide to Diagnostic X-Ray Equipment.
Specific Manufacturer Responsibilities
Manufacturers must meet the following obligations under the Performance Standards:
- Component Certification (21 CFR 1020.30(c)): Certify that each component complies with applicable standards when installed in accordance with the provided instructions.
- Permanent Labeling (21 CFR 1010.2, 1010.3):
- Affix or inscribe permanent certification and identification labels.
- Labels must include the manufacturer’s details, production location, and manufacture date.
- Assembly Instructions (21 CFR 1020.30(g)):
- Provide detailed instructions to assemblers for proper system assembly, installation, adjustment, and testing.
- Include specifications for compatible components to ensure compliance. These may include physical characteristics or model numbers of compatible components.
- User Manuals and Safety Procedures (21 CFR 1020.30(h)(1)):
- Provide manuals or instruction sheets to purchasers. Manuals must include:
- Radiological safety procedures and precautions specific to the equipment.
- Maintenance schedules to ensure ongoing compliance with performance standards.
Conclusion
In summary, the present document outlines and explains the critical regulatory responsibilities of manufacturers of diagnostic x-ray equipment. From certification and labeling to ensuring proper installation and maintenance, compliance with these requirements is vitally important for ensuring compliance with Radiological Health Regulations in general. The guidance also highlights the need for clear communication and documentation, facilitating both regulatory oversight and the safe use of diagnostic x-ray systems.
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