FDA Publishes FAQs on Market Access for Radiation-Emitting Electronic Products

Key Summary

FDA CDRH has published a Frequently Asked Questions (FAQ) resource on getting a radiation-emitting product to market. The document addresses general requirements, records and reports, performance standards and certification, and import requirements, and applies to manufacturers of products such as X-ray systems, laser products and microwave ovens. The guidance helps manufacturers, including companies in China, understand FDA regulatory requirements and achieve compliant access to the U.S. market.

Source and Applicability

• Source organization: FDA CDRH News & Updates
• Original publication date: July 23, 2026
• Publication date on this site: July 25, 2026, 10:41
• Source link: https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program/getting-radiation-emitting-product-market-frequently-asked-questions

This article is compiled and translated from public information published by FDA CDRH News & Updates. Specific requirements are subject to the latest official publications of the regulatory authority.

Full Translation: FDA FAQs on Market Access for Radiation-Emitting Electronic Products

General Requirements

Q1: Which products are regulated as radiation-emitting electronic products?

A: Regulated radiation-emitting electronic products include diagnostic X-ray systems, laser products, laser light shows, microwave ovens, cabinet X-ray systems, sunlamps and tanning beds, mercury vapor lamps, germicidal ultraviolet lamps, light-emitting diodes (LEDs) and body scanners. The terms "electronic product" and "electronic product radiation" are defined in 21 CFR 1000.3(j) and (k).

Q2: Who has regulatory authority over the manufacture and use of radiation-emitting electronic products?

A: FDA's Center for Devices and Radiological Health (CDRH) regulates radiation-emitting electronic products under the authority of Subchapter C of Chapter V of the Federal Food, Drug, and Cosmetic Act. CDRH's goal is to protect the public from hazardous and unnecessary radiation exposure from electronic products. For most electronic products, safety regulation is divided between CDRH and state regulators: CDRH regulates manufacture, while the states regulate use.

Q3: What is FDA's legal basis for regulating electronic product manufacturers, and what are the regulatory requirements?

A: FDA's statutory authority derives from Subchapter C of Chapter V of the Federal Food, Drug, and Cosmetic Act, "Electronic Product Radiation Control." Radiation safety regulations are contained in 21 CFR Chapter I, Subchapter J, Parts 1000-1040. Manufacturers must ensure that their products do not emit hazardous or unnecessary radiation and must comply with the requirements of 21 CFR Parts 1000, 1002, 1003, 1004 and 1005. Where a mandatory performance standard applies, 21 CFR Part 1010 must also be met.

Q4: Which other federal agencies are involved in radiation safety?

A: These include the U.S. Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH) and the Nuclear Regulatory Commission (NRC).

Q5: Am I a manufacturer?

A: A manufacturer is any person engaged in the business of manufacturing, assembling or importing electronic products (21 CFR 1000.3(n)).

Records and Reporting Requirements

Q6: Must records be kept and reports submitted to CDRH for radiation-emitting electronic products?

A: Yes. Manufacturers must maintain records and submit reports for their radiation-emitting electronic products. Specific reporting and recordkeeping requirements are listed by product in Table 1 to 21 CFR 1002.1.

Q7: When must the product report, supplemental report or abbreviated report required for a new product be submitted?

A: The product report, supplemental report or abbreviated report must be submitted before the product enters interstate commerce. For imported products, it should be submitted at least one month before importation so that CDRH can issue an acknowledgement letter containing the report accession number. The accession number is a unique number assigned by the CDRH Document Control Center (DCC).

Q8: When must the annual report be submitted?

A: Under 21 CFR 1002.13, the annual report is due by September 1 each year and covers the 12 months ending June 30 of the year of submission. For example, the report submitted on September 1, 2026 covers July 1, 2025 through June 30, 2026. There is a two-month "grace period" between June 30 and September 1 each year.

Q9: Where should reports be sent?

A: Manufacturers are encouraged to submit a single consolidated annual report covering all model families and production sites. Submission options include: preferably by email to RadHealthCustomerService@fda.hhs.gov; through the electronic Submission Gateway Next Generation (ESG NextGen); or by mail to the CDRH Document Control Center (address omitted).

Q10: How does a company notify CDRH when it sells a regulated product line to another company?

A: A company may "close out" specific models or the entire business by submitting an annual report. It may also submit a letter listing all acquired models and accession numbers as a supplement to the report. The new manufacturer must submit its own product report or supplemental report.

Q11: When does responsibility for radiation health reporting begin after a model or product line changes hands?

A: The new company becomes responsible for ensuring compliance when it begins manufacturing the acquired product, including establishing quality control inspection and testing programs and affixing the certification label before sale. The company must also submit its own radiation safety product report.

Q12: How can the predecessor company's reports be transferred to the new company?

A: A letter or email may be sent to CDRH/DCC identifying the models and report accession numbers to be transferred to the new company's name. However, the new company must still submit its own compliance report.

Q13: Do variance holders for laser light shows need to submit annual reports?

A: Yes. An annual report is required to maintain the variance approval and continue to conduct laser light shows.

Q14: Can radiation safety reports and correspondence be submitted to CDRH by email?

A: Yes. Radiation safety reports (including product reports, annual reports, supplemental reports, defect/noncompliance notifications, corrective action plans and accidental radiation occurrence reports) may be submitted by email. Reports should be in PDF format or packaged using eSubmitter. Other submission types such as 510(k)s and PMAs must not be submitted to this mailbox.

Q15: Can an incomplete product report be submitted first in order to begin selling immediately?

A: No. The report must contain all information required by regulation. Where CDRH has issued reporting guidance, its format should be followed.

Acknowledgement Letters and Accession Numbers

Q16: What is the purpose of the acknowledgement letter?

A: It notifies the submitter that the report has been received, entered into the database, and assigned a product code and accession number. An acknowledgement letter does not constitute approval or indicate that the report is adequate.

Q17: What is an accession number?

A: The accession number is the unique identifier for a report in the database and facilitates communication. FDA import staff also use the accession number to confirm that a manufacturer has met its reporting requirements.

Q18: Does an accession number mean CDRH has approved the product?

A: No. The accession number only indicates that the report has been received and entered into the database.

Q19: Where is the acknowledgement letter sent?

A: It is sent to the address of the person who submitted the report. If the submitter is not the manufacturer, it is sent only to the submitter.

Q20: How long after submitting a report will the acknowledgement letter be received?

A: Typically within four weeks. If it has not been received after four weeks, CDRH may be contacted. Electronic submissions generally receive confirmation within one day.

Q21: How can acknowledgement be expedited?

A: Use the eSubmitter electronic submission software.

Q22: Must a company wait to receive the acknowledgement letter before beginning shipments?

A: No, but submitting the report is a prerequisite. The acknowledgement letter and accession number are the evidence. The accession number must be indicated on FDA Form 2877 at the time of importation.

Q23: After an accession number is obtained, how long does CDRH take to approve the product?

A: CDRH has no authority to approve radiation safety. If CDRH does not contact the manufacturer, no significant deficiency has been identified. The acknowledgement letter and accession number do not constitute approval.

Q24: Will CDRH contact the manufacturer after reviewing the report?

A: It will not, unless there is a specific question.

Performance Standards and Certification

Q25: What is certification?

A: Certification is a manufacturer's statement that the product complies with applicable FDA performance standards and does not emit hazardous radiation. It is based on the manufacturer's own quality control testing program and does not represent FDA approval.

Q26: Will FDA approve my product certification?

A: No. Certification is the manufacturer's statement and must be supported by a quality control program demonstrating that each product complies with the standard.

Q27: How can I determine whether an FDA performance standard applies to my product?

A: See Table 1 to 21 CFR 1002.1. Mandatory performance standards are in 21 CFR Parts 1020-1050.

Q28: What if no FDA performance standard applies?

A: The manufacturer is still responsible for ensuring that the product does not emit hazardous radiation and for complying with the general requirements. Reports may still be required (see Table 1 to 21 CFR 1002.1).

Laser Standards and International Standards

Q29: For products subject to a mandatory FDA performance standard, does FDA accept other standards?

A: All products must comply with FDA standards. However, FDA is exercising enforcement discretion for certain laser standard requirements where the product is certified to the relevant clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (as described in Laser Notice No. 56). Note that Laser Notice No. 50 was withdrawn effective December 31, 2024.

Q30: Do products reported before the withdrawal of Laser Notice No. 50 need to resubmit product and supplemental reports?

A: Resubmission is not required, but a supplemental report is required if compliance is affected by the use of Laser Notice No. 56.

Q31: What is the status of products for which reports were previously submitted after the withdrawal of Laser Notice No. 50?

A: Laser products correctly certified on or before December 31, 2024 using Laser Notice No. 50 may continue to enter the U.S. market. After that date, only products conforming to 21 CFR 1040.10/1040.11 or to the IEC standards (as described in Laser Notice No. 56) may enter.

Q32: Do products certified under Laser Notice No. 50 need to be redesigned, re-evaluated and re-certified?

A: No. Products correctly certified before January 1, 2025 may continue to be marketed. If a manufacturer cannot certify a product after December 31, 2024 without using Laser Notice No. 50, it may apply for a variance.

Q33: Can laser illumination projectors be certified using Laser Notice No. 50?

A: No. Laser Notice No. 57 supersedes earlier notices, and IEC 62471-5 should be used.

Q34: How can FDA be contacted for advice on use of the laser notices?

A: Email RadHealth@fda.hhs.gov.

Electronic Product Standards and Requirements

Q35: We produce thousands of products each year. Must each one be tested individually?

A: Not necessarily. A statistically valid sampling plan may be used.

Q36: When is a product permitted to be sold in the United States?

A: When the manufacturer has ensured that the product does not emit hazardous radiation and, where a mandatory standard applies, that the product complies with the standard, that testing and quality control programs have been established, and that certification and identification information is permanently affixed to the product.

Q37: I want to import a medical laser product (or another medical radiation-emitting product). How do I obtain U.S. marketing authorization?

A: Such products are also medical devices and must comply with medical device regulations, including establishment registration, device listing and premarket review requirements.

Q38: Which standards and requirements apply to components of electronic products?

A: Certain components are subject to mandatory performance standards and reporting requirements. For example, diagnostic X-ray components must comply with 21 CFR 1020.30 and be certified; laser components may be exempt from the mandatory standard if specific conditions are met, but registration and distribution records are required.

Importing Electronic Products

Q39: What form must be submitted to the FDA import office for imported products?

A: A declaration of products subject to radiation control standards (FDA Form 2877) must be filed through U.S. Customs and Border Protection. Noncompliant products will be refused entry.

Q40: As a foreign manufacturer, when must I designate a U.S. agent?

A: A U.S. agent must be designated when preparing the product report. See 21 CFR 1005.25.

Q41: Are radiation-emitting electronic medical products imported into the United States under an FDA-approved Investigational Device Exemption (IDE) exempt from the mandatory performance standards of the radiation health program?

A: No. The mandatory performance standards in 21 CFR Parts 1000-1040 must be met. An IDE exempts a device only from medical device performance standards (Section 514 of the FD&C Act), not from electronic product performance standards (Section 534). The product must comply with the standard, be certified, and have a complete product report submitted before release.

Product-Specific Questions

Q42: Are light-emitting diode (LED) or intense pulsed light (IPL) products subject to laser regulations and reporting requirements?

A: LED and IPL products do not meet the definition of a laser, but as radiation-emitting products they are subject to the general requirements (21 CFR Parts 1000-1005), including accidental radiation occurrence notifications and defect notifications. No FDA mandatory performance standard currently applies, and no product report or annual report is required.

Obtaining More Information

Q43: Can CDRH be contacted for guidance on specific requirements of performance standards or applicable regulations?

A: Yes. Provide detailed product information when contacting CDRH. Questions may be sent to DICE@fda.hhs.gov or addressed through the radiation-emitting products web pages.

AIMEILI Regulatory Interpretation

This FAQ published by FDA CDRH is an authoritative reference for compliance of radiation-emitting electronic products and is highly relevant to medical device companies planning to enter the U.S. market. It should be incorporated into regulatory intelligence and post-market monitoring processes rather than read merely as general news. Companies should determine whether the update is a guidance document, recall or safety communication, product approval, digital health item, quality system topic or post-market regulatory information, and confirm whether it affects existing registration projects or products in development.

Where the content involves specific products, test performance, risk signals or regulatory action, companies should further assess the impact on product classification, the 510(k), De Novo or PMA pathway, technical documentation, labeling and instructions for use, quality system records and post-market reporting obligations. For U.S. registration programs in progress, the source link, publication date, scope of applicability and internal conclusions should be recorded in the project file.

Key areas to review include the basis for product classification, applicable regulatory provisions, predicate device or substantial equivalence assessment, performance testing, software and cybersecurity documentation, risk management, clinical evidence, labeling and instructions for use, and quality system readiness.

Common risks include misjudging the FDA pathway, overlooking changes in guidance documents, inadequate performance test design, overly broad labeling claims, unclear post-market reporting obligations, and applying documentation prepared for other markets directly to U.S. registration.

Business Impact for Manufacturers

Registration Pathway and Product Classification

The FAQ clarifies the scope of regulated products, including X-ray systems, laser products and microwave ovens. Companies should first confirm whether a product is a radiation-emitting electronic product and whether a mandatory performance standard applies. Laser products, for example, must comply with 21 CFR 1040.10/1040.11 or the applicable IEC standards (as described in Laser Notice No. 56). Although LED and IPL products are not subject to the laser regulations, they remain subject to general reporting and defect notification requirements.

Technical Documentation and Clinical Evaluation

For medical radiation-emitting products such as diagnostic X-ray systems and medical lasers, medical device registration requirements (for example 510(k) or PMA) apply in addition to the electronic product regulations. The FAQ confirms that an IDE does not exempt a product from electronic product performance standards, so devices used in clinical trials must also be certified and reported. Technical documentation should include radiation safety test data, quality control programs and certification labels.

Performance Verification and Quality System

Manufacturers must establish testing and quality management programs, and statistically valid sampling may be used. Certification statements must be based on effective quality control procedures. Where a product line is acquired, the new company must update its own testing procedures, labels and operational manuals and submit a new product report. Exporters should ensure that the quality management system meets FDA expectations and that compliance evidence can be provided.

Labeling, Instructions for Use and U.S. Agent

Certification and identification information must be permanently affixed to the product. Imported products require a designated U.S. agent, identified in the product report. At importation, FDA Form 2877 must be submitted with the accession number indicated. Labeling content, including laser classification and warning statements, must follow the applicable standards.

Post-Market Maintenance

The annual reporting obligation is ongoing (due by September 1 each year) and covers the period from July of the preceding year through June of the current year. Discontinued products or business exits should be closed out through the annual report. Defects and radiation incidents must be reported to FDA promptly. For laser products, transitioning from Laser Notice No. 50 to No. 56 may require a supplemental report. Companies should establish post-market surveillance processes to track regulatory changes such as the withdrawal or update of laser notices.

Frequently Asked Questions

Does an update to an FDA public web page always represent a regulatory change?

No. A distinction must be drawn between news items, guidance documents, database pages, recall information and formal regulatory documents. For material items, the original FDA source and the applicable regulations should be consulted before any conclusion is drawn.

What should a company do after seeing an FDA update?

First assess whether the update affects product classification, the registration pathway, technical documentation or post-market obligations, and then decide whether the project plan needs to be updated.

Content Review and Scope of Application

Author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Source principles: priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references. Scope: this article supports preliminary understanding, document preparation and project planning and does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.