Where to Start
|New manufacturers or importers|
- View this video:
- And then start at (1.1).
|Experienced manufacturers or importers of any radiation-emitting products|
- skip ahead to your particular product area under question (3) to see what’s new (electronic submissions or recently posted industry guidance)
1.1 Are you involved in manufacturing or importing any radiation-emitting products or radiation-emitting medical devices (21 CFR §1000.3(n))
- As a manufacturer or importer of regulated radiation-emitting electronic products, you have certain reporting and recordkeeping responsibilities. ( 21 CFR 1002)
No - But I am a distributor of radiation-emitting products or radiation-emitting medical devices
- As a distributor of regulated radiation-emitting electronic products, you have certain recordkeeping responsibilities. ( 21 CFR 1002.40)
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.
Generally speaking, if your firm is subject to these regulations, there are four steps you must follow prior to marketing your product in the United States.
- Design your product to comply with the applicable performance standard. This means that your product is designed so that it does not permit unnecessary exposure to radiation during use by complying with the requirements of the applicable performance standard.
- Good quality control during manufacturing to assure compliance to the applicable performance standard. This means that your firm may sell your radiation-emitting product after (a) you have assured that your product is manufactured following an adequate quality control and testing program such that there is no unnecessary exposure to radiation during use and (b) the following two steps have been completed.
- Certification of each unit that it complies with the performance standard. This means your firm is responsible for certifying that each unit complies with the applicable performance standard, and the units are labeled as such (21 CFR 1010).
- Submission of the applicable Product report to FDA to demonstrate that your product complies with the standard.
This means that a Product report has been submitted to FDA/CDRH to demonstrate compliance to the applicable standard. There are other reporting and record keeping requirements specified in 21 CFR 1002 – 1005 (see: Laws and Regulations (Radiation-Emitting Products)
1.3 Frequently Asked Questions about the Radiological Health Program
|Information about FDA’s procedures and when the manufacturer may begin shipping the product can be found at the website Getting a Radiation Emitting Product to Market|
- Your product must comply with 2 independent sets of regulations. It must comply with radiation safety regulations specified under 21 CFR 1000-1050 and described within these webpages. Separately, it must comply with device regulations, which may include establishment registration, device listing, and premarket notifications and approvals. See Device Advice
Firms that manufacture veterinary radiation emitting devices need to comply with the radiological health regulations, administered by CDRH. However, radiation emitting devices intended for veterinary use only although considered medical devices as defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, are regulated by the Center for Veterinary Medicine, see: Is The Product A Medical Device. Please note, that there is a labeling requirement (21 CFR 801.109) to restrict sale to veterinarians, as appropriate.
|No ||See your product area in the list below. |
3. What type of radiation-emitting product is this?
Topic links include pertinent Radiological Health policies, industry guidance, and specific reporting forms in PDF.
Please bookmark your product page and check back for new policies or guidance. Updates can be effective immediately and require your attention. There may be modifications or relaxations to requirements that will be of interest to you.
No Performance Standard:
Radiation emitting products that are not covered by the performance standards listed in 21 CFR 1020-1050 are still subject to general requirements in the Title 21 CFR 1000-1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004.
4. Reporting: to determine what, if any, reporting requirements your product is subject to, see Table 1, 21 CFR 1002.1 and descriptions of the reports 21 CFR 1002.10-13.
Once you have determined that your firm is obliged to submit some kind of report or other submission to FDA concerning a radiation-emitting product or device, you have three ways by which you may submit your information: (a) on CD after preparing your submission with FDA software; (b) through the FDA Electronic Submissions Gateway after using the FDA software; (c) or paper.
- 4.1: Electronic on CD by mail
- 4.2: Electronic through the FDA Gateway
- 4.3: Paper
|4.1 Electronic on CD by mail|
Preparing your submissions using the FDA eSubmitter electronic submissions software is the best way to prepare information for submission to FDA.
Once the submission has been completed and packaged following the FDA eSubmitter instructions, you may copy the report package (a ZIP file) to a CD and mail the CD and your signed submittal letter to the FDA address given in the eSubmitter software. If the submission is a report, the CD will be processed by our Document Control Center and you will receive an acknowledgement email within a few days giving you the FDA assigned Accession Number for the report.
This option may be the best option when you have a need to submit a report immediately, but it doesn’t offer the fastest response for the acknowledgement email notice. The FDA Gateway provides the fastest response (minutes instead of days).
|4.2 Electronic through the FDA Gateway|
Preparing the report for submission via the FDA Electronic Submissions Gateway is the same as preparing one to submit on a CD. However, it is necessary to establish a WebTrader account with the FDA Gateway before you can submit through the Gateway.
The FDA Electronic Submissions Gateway has its own separate web site where you can find information about the Gateway and the procedures for setting up an account.
Of particular help are the links on the left side of the homepage to Center-Specific Submission Preparation Guidelines, Setting up a WebTrader Account Checklist, and the Tutorials link under Resources for You.
Submissions made through the FDA Gateway are automatically routed to the proper Center for control by its Document Control Center. Reports submitted to FDA for radiation-emitting products will typically be acknowledged by email within a few minutes or hours.
Please note, there are two different Help Desk email addresses provided, one for setting up an account and answering policy questions and the second for problems with particular submissions.
Product reports may also be prepared using the printed paper reporting guides we have had for many years and mailing the report to FDA. These reports will be controlled by the Document Control Center and an acknowledgement letter will be mailed to the reporting official and the submitter within about 30 days.
The paper reporting guides are available for the particular kind of electronic product being reported from the Radiological Health web site.
|5. Imports: Is your product being shipped to the United States for sale?|
U.S. Agent - All imported radiation-emitting products must meet established standards; and all products must contain informative and truthful labeling in English. Every manufacturer of electronic products, prior to offering such product for importation into the United States, shall designate a permanent resident of the United States as the manufacturer's agent upon whom service of all processes, notices, orders, decisions, and requirements may be made for and on behalf of the manufacturer.
|No||I am a domestic manufacturer. |
6. Adverse Event reporting.
Reporting of accidental radiation occurrences - 21 CFR 1002.20(a)
Whenever they hear of an incident, manufacturers of radiation-emitting electronic products must immediately report accidental radiation occurrences (AROs) to CDRH following the instructions in 21 CFR 1002.20(a). The report may be submitted in the form of a letter, following the instructions in 21 CFR 1002.20(b).
Also, both manufacturers and anyone in the general public may use the following fillable form to submit a report on any radiation incident or potentially hazardous event: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM236066.pdf
Alternatively, manufacturers may use the FDA eSubmitter software to prepare and submit ARO reports and other correspondence electronically. You can download the FDA eSubmitter software and follow the instructions that accompany the software. More information on the FDA eSubmitter software can be found on the FDA web site.
Medical Device Adverse Event reports - 21 CFR 803
If your radiation-emitting product is also a medical device, the MedWatch Medical Device Reporting (MDR) requirements supersede the ARO reporting requirements noted above. A manufacturer does not need to file both an ARO and MDR for the same adverse event.
The MDR regulations require firms and other entities which become aware of deaths, serious injuries and in some cases malfunctions associated with the medical devices to notify the FDA using Form 3500A. The MedWatch program also has provisions for voluntary reporting of a death, serious injury or malfunction associated with a medical device by anyone who wishes to make FDA aware by using Form 3500. Please visit: http://www.fda.gov/Safety/MedWatch/default.htm
7. Variances or Exemptions from the Performance Standards (21 CFR 1000-1050)
For Manufacturers who have a new product that doesn’t fit the existing performance standards – what can you do?
If certain requirements are not appropriate or would cause the new product not to be able to function as intended, manufacturers of products that are subject to performance standards in 21 CFR 1020-1050, may be granted variances or exemptions from these requirements under certain circumstances.
- Variances - For a product the design of which does not comply with a certain requirement of the applicable performance standard (See regulations and procedures in 21 CFR 1010.4)
- Exemptions from certain performance requirements for products intended for sale to Government agencies - For products developed under contract with the US Department of Defense or other federal agencies, see regulations and procedures at 21 CFR 1010.5 and Exemptions From Electronic Products Regulations.
- Exemptions from notification requirements – For products already in commercial distribution which are determined to exhibit a defect or failure to comply with an applicable regulatory requirement, but which can be shown not to create a significant risk of injury, including genetic injury, to any person, see regulations and procedures at 21 CFR 1003.30 and 21 CFR 1003.31.