Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation
(from the CDRH website updated June 28, 2006)
General Requirements
Q1) What products are regulated as electronic products that emit radiation?
A) Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. Legal definitions of the terms electronic product radiation and electronic product are located in the Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control. 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 that may be produced by an electronic product. 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?
A) 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.
For further information on CDRH regulations that apply to manufacturers of electronic products see the CDRH web site: http://www.fda.gov/cdrh/radhealth/lawsregstandards.html
Suggested State Regulations for safe use can be found at the Conference of Radiation Control Program Directors, Inc.’s web site (http://www.crcpd.org/). CRCPD’s web site also contains contact information for each state’s regulatory agency.
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?
A) CDRH is an organizational component of FDA.
Q4) What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products?
A) 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. http://www.fda.gov/opacom/laws/fdcact/fdcact5c.htm
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?
A) The U.S. Environmental Protection Agency (EPA) is responsible for issuing general radiation guidance to Federal Agencies. Additionally, basic information about radiation is available on the EPA web site (http://www.epa.gov/radiation/index.html). The U.S. Occupational Health and Safety Administration (OSHA) has regulations on protecting workers from radiation in the workplace (http://www.osha.gov/). The National Institutes of Occupational Safety and Health does work place assessments of potential work place hazards including radiation (http://www.cdc.gov/niosh/homepage.html). The U.S. Nuclear Regulatory Commission has jurisdiction over radioactive materials used in nuclear reactors and radioactive materials that are man made (http://www.nrc.gov/).
Q6) Am I a manufacturer?
A) Manufacturer means any person engaged in the business of manufacturing, assembling, or importing electronic products.
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Requirements for Records and Reporting
Q7) Am I required to maintain records and submit reports to CDRH?
A) Title 21 CFR 1002 contains reporting and record keeping requirements for manufacturers of electronic products that emit radiation. The specific requirements for reporting and record keeping are listed by product in Table 1 of 21 CFR 1002.
Q8) When do I have to submit the product, supplemental, or abbreviated report required for my new product?
A) 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. Additionally, 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 us 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 are annual reports due?
A) Annual reports (Title 21 CFR 1002.13) are due September 1 of every year. The report should cover production for the United States from July 1 of the previous year through June 30 of the current year.
Q10) Where do I send my report?
A) Our mailing addresses are found at: http://www.fda.gov/cdrh/radhealth/address.html. Alternatively, when you want to submit a report or correspondence using our electronic submissions software follow the instructions found at: http://www.fda.gov/cdrh/cesub/
Q11) If I want to sell my product immediately, is it acceptable to initially submit an incomplete product report?
A) 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 (http://www.fda.gov/cdrh/radhealth/reporting.html) or use the CeSub eSubmitter electronic reports software to prepare your report (http://www.fda.gov/cdrh/cesub/).
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Acknowledgement Letters and Accession Numbers
Q12) What is the purpose of the acknowledgement of receipt letter?
A) The CDRH acknowledgement letter is intended to tell you:
- your report has arrived;
- it has been entered into our database; and
- your report’s accession number.
An acknowledgement of receipt letter is not an approval of your product nor does it mean that your report is adequate.
Q13) What is an accession number?
A) Accession numbers are unique identifiers for reports in our database, and are provided in the CDRH acknowledgement letters. An accession number facilitates communication about specific reports because all parties can use the accession number to identify the document being discussed. Additionally, FDA imports personnel use accession numbers to confirm that a manufacturer has, at a minimum, complied with the reporting requirements for the product being imported.
Q14) Does an accession number for my report mean that CDRH has approved my product?
A) No. An accession number means that your report has been received by CDRH’s file room, and some information about the manufacturer and product were entered into our database.
Q15) Where are acknowledgement letters sent?
A) Acknowledgement letters are returned to the address provided for the report submitter. Only one copy of the letter is sent. If the submitter is different from the manufacturer, the letter is only sent to the report submitter. The submitter may send a copy to the manufacturer. When a report is submitted electronically the acknowledgement letter is sent by e-mail to the submitter and the Manufacturer’s Reporting Official
Q16) How long after I submit my report may I expect to receive an acknowledgement letter from CDRH?
A) Wait at least four weeks after you mailed your product report, abbreviated report, annual report or supplemental report before making an inquiry. If you have not received your acknowledgement of receipt letter after four weeks from the date you submitted your report you may contact CDRH at: Center for Devices and Radiological Health; ATTN: Question about submitted report (HFZ-240); Office of Communication, Education, and Radiation Programs; 9200 Corporate Boulevard; Rockville, MD 20850. Our phone number is (240) 276-3332. If you do contact us, tell us the names of the manufacturer and submitter, the model name or number, date the report was sent, the exact address you used, the name of mail service used, and any associated tracking number. We will not respond to inquiries less than four weeks from the date you sent the report.
If you submit your report electronically an email acknowledgement message will be sent out as soon as the submission is successfully loaded into the CDRH database. Typically an electronic report is loaded within one day of receipt.
Q17) Is there something I can do to assure a faster acknowledgement of receipt of my report?
A) Yes. We are developing electronic submissions software for documents required by CDRH. At this time, a prototype software application is available. Reports prepared and submitted using this software may be acknowledged significantly faster than a traditional report submitted on paper. For more information please see: http://www.fda.gov/cdrh/cesub/
Q18) Do I have to wait until I receive an acknowledgement letter with my accession number before I can begin shipping my products to customers?
A) No. However, you are required to submit reports to CDRH before introducing products into United States commerce. The acknowledgement letter and accession number are evidence that the report was received by CDRH. If your product is made in another country for import into the United States, the import clearance process requests identification of the accession number on the import affirmation form, FDA 2877 when that form is required. The form FDA 2877 is available at: http://www.fda.gov/opacom/morechoices/fdaforms/default.html
Q19) How long does it take for CDRH to approve my product after a report receives an accession number?
A) CDRH does not approve electronic products that emit radiation. CDRH does not have the authority, nor does any other federal agency, to approve the radiation safety of an electronic product that emits radiation. If CDRH has not contacted you about your report, it means that we have not identified any significant deficiencies with the report or questions about your product.
Q20) Will CDRH contact me after review of my report?
A) You will not be contacted if CDRH has no questions about your product or the report. You will be contacted if we have questions about your product or report.
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Performance Standards and Certification
Q21) What is certification?
A) Certification means that the manufacturer of a radiation-emitting electronic product states that the product complies with an applicable FDA performance standard and does not emit hazardous and unnecessary radiation. Certification is based upon the manufacturer’s own quality control testing program and does not indicate FDA approval.
Q22) Does FDA approve the certification of my product?
A) No. Certification is a manufacturer’s statement that its product complies with the applicable standard. The manufacturer is responsible for assuring the certification (21 CFR 1010) that a product complies with an applicable standard is true to the best of its knowledge. This statement of certification must be based on a quality control and testing program which can demonstrate that each product manufactured complies with the applicable standard.
Q23) How do I know if an FDA performance standard applies to my product?
A) Table 1 of 21 CFR 1002.1 shows a list of products followed by a reference to any applicable standard. Mandatory radiation safety performance standards are contained in Title 21 CFR Parts 1020 through 1050. The first section of each standard defines and describes products subject to that standard.
Q24) What if no FDA performance standard applies to my product?
A) It is the manufacturer’s responsibility to produce a product that does not emit hazardous and unnecessary radiation and to comply with the general requirements in Title 21 CFR 1000 through 1005.
Q25) For products with an applicable FDA mandatory radiation safety performance standard, are there any other standards that FDA will accept?
A) With the exception of the provision of Laser Notice 50 (http://www.fda.gov/cdrh/comp/guidance/1346.html), all products with an applicable standard must comply with the U.S. FDA’s standard before entering the U.S. or its territories. FDA does not recognize regulatory approvals from other countries or other organizations.
Q26) We make thousands of products a year; do we have to test each one?
A) Not necessarily. When appropriate, you may use a statistically valid sampling plan as a part of your quality control and testing program. Any sampling plan must conform to appropriate consensus standards on quality control sampling.
Q27) When am I allowed to sell my product in the United States?
A) You may sell your product when you have assured your product does not emit hazardous and unnecessary radiation. Additionally, if there is an applicable mandatory federal radiation safety performance standard:
- Your product must comply with the applicable standard;
- You must establish a testing and quality control program sufficient to prove your product is completely compliant with its applicable standard (Title 21 CFR 1020 through 1050);
- Your product must have certification and identification information permanently affixed or inscribed as required in the general performance standard (Title 21 CFR 1010). You may only place a certification label on a product if your certification is based on an adequate quality control and testing program. The certification label is your statement that your product conforms to the applicable standard (Title 21 1010.2).
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Importation of Electronic Products
Q28) What form do I need to submit to the FDA Imports office to import my product into the U.S.?
A) Importers of radiation-emitting electronic products subject to an FDA performance standard are required to submit a written declaration on "Declaration of Products Subject to Radiation Control Standards," form FDA 2877, along with other import entry information, through U.S. Customs Border Protection (CBP) to the appropriate FDA imports office. Electronic products that emit radiation, which fail to comply with the applicable performance standard or do not have a certification label or tag (21 CFR 1010.2) affixed to each product shall be refused entry. If your product is subject to a performance standard, one way to indicate you have reported your product as required to FDA is by including the accession number on form FDA 2877.
Form FDA 2877 is available at: http://www.fda.gov/opacom/morechoices/fdaforms/default.html .
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Getting More Information
Q29) Is it acceptable to contact CDRH to get guidance on the meaning of specific requirements of a performance standard or applicable regulation?
A) Yes. We want you to understand our requirements. We will post the most frequently asked questions to this web site and ask that you look for an answer here or in the guidance and compliance guides that we have already published before you contact us. When you do contact us, please try to be specific about the details of your product and what part of the standard or other regulation is unclear to you. You may contact CDRH at: Center for Devices and Radiological Health; Office of Communication, Education, and Radiation Programs (HFZ-240); 9200 Corporate Boulevard; Rockville, MD 20850. Our phone number is (240) 276-3332.
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