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Getting Your Product to Market (FAQs)
April 25, 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.
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.
Records and Reports (21 CFR 1002)
Reporting and Recordkeeping Requirements by Product (21 CFR 1002.1, Table 1)( Printer Friendly Version). Reports Required Prior to Introduction of an Electronic Product which Emits Radiation into United States' Interstate Commerce
Exemptions from Reporting
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/).
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.
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).
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 .
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.
Updated August
26, 2008 |
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