Getting a Radiation Emitting Product to Market
- General Requirements
- Requirements for Records and Reporting
- Acknowledgement Letters and Accession Numbers
- Performance Standards and Certification
- Importation of Electronic Products
- Product Specific Questions
- Getting More Information
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 Laws and Regulations (Radiation-Emitting Products) section.
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. Federal Food, Drug, and Cosmetic Act, Chapter 5, 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?
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.
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.
Reporting and Recordkeeping Requirements by Product (21 CFR 1002.1, Table 1). Reports Required Prior to Introduction of an Electronic Product which Emits Radiation into United States' Interstate Commerce
- 21 CFR 1002.10 Product Reports
- 21 CFR 1002.11 Supplemental Reports
- 21 CFR 1002.12 Abbreviated Reports
- 21 CFR 1002.13 Annual Reports
Exemptions from Reporting
- 21 CFR 1002.50, Special exemptions
- 21 CFR 1002.51, Exemptions for manufacturers of products intended for the U.S. Government
Compilation and Summary of Exemptions under the Radiological Health Program
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) Annual Report submission and 1 year effectiveness period
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. The Reporting forms or guides for Annual Reports may be found in the electronic submissions software, CeSub, 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.
Q9a) When my company sells a regulated product line to another company, how do we inform FDA/CDRH?
A) Your company can inform the FDA/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.
Q10) Where do I send my report?
A) Our mailing addresses are found at: Addresses for Electronic Product Radiation Control Reports and Recordkeeping. Alternatively, when you want to submit a report or correspondence using our electronic submissions software follow the instructions found at: FDA eSubmitter
Q10a) May I submit reports and correspondence to CDRH via email?
A) No. We cannot accept documents from industry via email. If you want to submit paper reports or CeSub submissions on CD, please mail your paper documents or CeSub on CD (with signed cover letter) to the address given here: Addresses for Electronic Product Radiation Control Reports and Recordkeeping.
You may use the FDA eSubmitter software and submit documents electronically. The CeSub 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.
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 please see Records and Reporting (Radiation-Emitting Products) or use the FDA eSubmitter electronic reports software to prepare your report.
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
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone number 301-796-6627.
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 now offer electronic submissions software for all documents required by the Radiological Health program in CDRH. At this time, CeSub, the electronic submissions software application is available and is being used every day by industry. Reports prepared and submitted using this software may be acknowledged significantly faster than a traditional report submitted on paper. You may use the FDA eSubmitter to submit documents electronically. The CeSub 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.
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: FDA Forms
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.
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.
Note: The only routine communication sent by CDRH regarding radiation safety is an acknowledgement of receipt (see Q12). Only manufacturers with safety issues or potential safety issues receive letters from FDA.
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, 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 CFR 1010.2).
Q27a) I want to import a medical laser product (or other medical radiation-emitting product), what do I need to do to get it approved for U.S. market?
A) Because they are medical devices, medical laser products and other medical radiation-emitting products must also comply with the medical device regulations, establishment registration, and device listing reporting requirements. For more information, see "How to Market Your Device."
Q28) What requirements are applicable to components of electronic products?
A) Some components are subject to performance standards and reporting requirements.
For example, some diagnostic x-ray components are subject to specific requirements in 21 CFR 1020.30 and must comply and be certified. Diagnostic x-ray components subject to the standard must also be reported as specified in 21 CFR 1002.
Laser components are exempt from the performance standard in 21 CFR 1040.10 & 11, so long as they meet specific applicability requirements identified in 21 CFR 1040.10(a). Laser component manufacturers must register their firm and list their products by submitting a document as described in 21 CFR 1040.10(a)(3) and maintain distribution records.
Only the diagnostic x-ray and laser standards have specific requirements for components (certification or registration). For all other products 1002.10, 1002.11, 1002.12, and 1002.13 apply to systems. Systems might require assembly by the user or might be fully assembled systems.
Q29) 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.
Q30) As a foreign manufacturer, when do I need to identify a U.S. Agent?
A) Now, when you submit your product report. Please see the regulation at the U.S. Agent page. If your products are also medical devices, this page will be applicable to you as well, see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm
Q30a) Are imported devices entering the U.S. under an FDA approved IDE also exempt from complying with performance standards under the Radiological Health program?
A) No, they must comply with applicable radiation standards. An Investigational Device Exemption (IDE) does not affect products subject to U.S. Federal performance standards. Noncompliant radiation emitting electronic medical products subject to a standard (such as medical x-ray, medical laser, and therapy ultrasound) cannot be legally imported and/or distributed and used domestically under an IDE for clinical studies because the performance standards already exist for these products. Medical devices that are also radiation-emitting products must comply with both medical device regulations as well as electronic product regulations. Electronic product regulation 21 CFR 1010.1 states the standards listed in that subchapter are prescribed pursuant to performance standards under section 534 of the Food, Drug, & Cosmetic Act. Therefore, although an IDE would provide exemptions from section 514 (medical device performance standards), it does not exempt manufacturers from section 534 (electronic product performance standards), which means those regulations in 21 CFR 1000 - 1050 must still be followed for radiation emitting products used in clinical studies conducted following an approved IDE. The product must nevertheless comply with the applicable standard(s), be certified, and a completed and accurate product report must be submitted to CDRH before the product is released to the importer and clinical investigators, as required by 21 CFR 1002.10.
Q31) Are LEDs or IPLs subject to the laser regulations and reporting?
A) Neither Light Emitting Diodes (LEDs) nor Intense Pulsed Light sources (IPLs) meet the definition of a laser, namely:
21 CFR 1040.10(b)(19) Laser means any device that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to 1.0*106nm primarily by the process of controlled stimulated emission.
Since they do not meet the definition of a laser as the source of the light (and assuming the products do not otherwise incorporate a laser), they are not subject to the laser standard. There is no existing FDA performance standard for Light emitting diodes or Intense Pulsed Light products. They are not subject to Product or Annual reports under 21 CFR 1002. However, as they are radiation-emitting products, the manufacturers of these products would still be subject to the general requirements in Title 21 CFR 1000 through 1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004.
Q32) 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 Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002