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Q1) What products are regulated as electronic products that emit radiation? Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. X radiation (x-rays), microwaves, radio waves (radiofrequency (RF)), laser, visible light, sound, ultrasound, and ultraviolet light are a few examples of the many types of radiation-emitting electronic products. Diagnostic x-ray systems, laser products, laser light shows, and microwave ovens are a few examples out of the many different electronic products that emit radiation.
Q2) Who has regulatory authority over the manufacture and use of radiation-emitting electronic products? The United States (U.S.) Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products. The CDRH goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. For most electronic products, safety regulation is divided between CDRH and state regulatory agencies. CDRH regulates the manufacture of the products, and the states regulate the use of the products.
Note: Manufacturers may be subject to additional FDA regulations if their product is intended to be used in a medical application (Medical Devices) or for irradiation or inspection of food (Title 21 CFR 179 Food Irradiation). These regulations do not address radiation safety and their details are beyond the scope of this document.
Q3) What is CDRH’s relationship with the FDA? CDRH is an organizational component of FDA.
Q4) What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products? The FDA’s statutory authority to regulate these products is granted by the United States Federal, Food, Drug and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control.
Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 through 1050 (21 CFR 1000 – 1050) contains radiation safety regulations for manufacturers of radiation-emitting electronic products. Manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation. All manufacturers must comply with the applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the standard. Mandatory radiation safety performance standards are found in 21 CFR 1020 – 1050.
Q5) What other Federal Agencies are involved in radiation safety? The U.S. Environmental Protection Agency (EPA) is responsible for issuing general radiation guidance to Federal Agencies.
The U.S. Occupational Health and Safety Administration (OSHA) has regulations on protecting workers from radiation in the workplace.
The National Institutes of Occupational Safety and Health does assessments of potential work place hazards including radiation.
Q6) Am I a manufacturer? Manufacturer means any person engaged in the business of manufacturing, assembling, or importing electronic products.
Requirements for Records and Reporting
Q7) Am I required to maintain records and submit reports to CDRH? Yes. Manufacturers are required to maintain records and submit reports to CDRH for their electronic products that emit radiation.
Q8) When do I have to submit the product, supplemental, or abbreviated report required for my new product? Your report must be submitted before you sell your product. Early submission of your report increases the probability that CDRH can contact you about problems before you sell your product.
If your product is an import, please send in your report at least one month before you present your products for import. A month allows CDRH time to provide an acknowledgement of receipt which will include the report’s accession number. An accession number is a unique identification number for your report, assigned by the CDRH Document Control staff when the report is received.
Q9) When do I have to submit my Annual Report? Annual reports are due September 1 of every year. The report should cover production for the US from July 1 of the previous year through June 30 of the current year. The Reporting forms or guides for Annual Reports may be found in the electronic submissions software. For each product area, see: FDA eSubmitter, and may also be found in PDF under the Industry Guidance section of each product area from the Radiation-Emitting Products homepage.
There is a 2-month "grace" period between June 30th and September 1st of each year when the annual report submitted by September 1 of the previous year is still valid while the manufacturer prepares a report due by September 1 of the current year. For example, an annual report for July 1, 2007 - June 30, 2008 that was submitted by September 1, 2008, is still valid through September 1, 2009.
Q10) When my company sells a regulated product line to another company, how do we inform FDA/CDRH? Your company can inform CDRH by submitting an Annual Report to "close out" either a particular model or your entire involvement in the electronic product manufacturing business.
Situation 1: A firm makes a radiation-emitting electronic product (one or a cluster of many) and then stops making electronic products. They file one more Annual Report and say they are now out of the business of making electronic products. No more Annual Reports are expected unless they resume making electronic products.
Situation 2: A firm makes one or several electronic products and then stops making them, but still makes others. They still need to submit Annual Reports, but the models they stopped are marked as discontinued effective on a certain date. We no longer expect to find those models in the Annual Report.
If your company prefers not to wait to submit an Annual Report, you may also submit a letter listing all the models and Accession numbers that are being acquired by another company. This letter serves as a report supplement for each Accession number and the CDRH Document Management Center will update each Accession number to reflect the new ownership. It would be expected that the new certifying manufacturer would submit a new supplement for each model describing any changes introduced by the firm that affects its compliance to the performance standard, such as component changes, the new certification and identification label, maybe other labels, the firm's own quality control inspection & testing procedures, and a new Operator's manual as soon as they are printed.
Q11) Where do I send my report? Please send your report to our mailing addresses:
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Alternatively, when you want to submit a report or correspondence using our electronic submissions software, follow the instructions found at: FDA eSubmitter
Q12) May I submit reports and correspondence to CDRH via email? No. We cannot accept documents from industry via email.
You may use the FDA eSubmitter software and submit documents electronically. The eSubmitter software correctly packages and the FDA Gateway authenticates and validates electronic submissions for routing to CDRH. In some instances CDRH staff may request that documents be submitted by email, but this may only be done following a specific request from CDRH.
Q13) If I want to sell my product immediately, is it acceptable to initially submit an incomplete product report? No. The reports you submit must contain all of the information required by the applicable regulation (21 CFR 1002.10 through 1002.12). If CDRH has published a reporting guide for your product, please follow the format and organization in the reporting guide when preparing your report please see Records and Reporting (Radiation-Emitting Products) or use the FDA eSubmitter electronic reports software to prepare your report.