FDA 3630 Sunlamp (esubmitter)

3630 Sunlamp Product rpt (OMB 0910-0025)
Section: eRadHealth Menu
Introduction

Electronic Product Radiation Safety Reporting
Form
This software application is intended to automate the hard copy product reporting forms in the effort of the Center for Devices and
Radiological Health (CDRH) to become capable of accepting electronic submissions from industry and to improve our review
process. This FDA Electronic Submission (eSub) software is the next version of the application developed to allow us to accept all
Radiological Health reports and other submissions electronically and improve the ability of CDRH to accomplish its mandated
product and industry evaluations in a timely and efficient manner.
All electronic reports and correspondence can either be transferred to CD and mailed to the address below, or can be sent via the
FDA Electronic Submissions Gateway to CDRH. If you follow instructions to set up an account with the FDA Gateway, it currently
may take several weeks,, but when you submit through it you will receive your acknowledgement email message with Accession
Number within minutes! Or, in the interest of faster turn-around for a one-time urgent report of if you submit few reports, you may
simply fill out this template creating the submission and then at 'Packaging' follow the instructions to transfer the files to a CD to
mail in. This method of submitting your report will be acknowledged by an email with the Accession Number within several days.
Information about the FDA Electronic Submissions Gateway can be found at
www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Please contact the Gateway Helpdesk with your
questions about that system.
Electronic submissions on CD should be mailed directly to the Document Control Center at:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Submissions received in the mail on CD will be processed within a few days of receipt.
Note about eSubmitter software:
Instructions provided in this software briefly summarize the requirements of the regulations under the Federal Food, Drug and
Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of
electronic products that emit radiation. The software provides questions relevant to requirements in the performance standards and
may include explanations or clarification about the performance, labeling, and informational requirements of the standard. It does
not replace the regulations, however, and if there is any conflict between the software and the regulations, the regulations must
prevail. Throughout this application, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in
parentheses. Please consult them before making design or procedural decisions.
Regulatory requirements for radiological products can be found at http://www.fda.gov/Radiation-EmittingProducts/default.htm
and for medical devices are located at www.fda.gov/M/devaDvices/default.htm. If you have specific questions about the
regulations, please contact us at: [email protected].
If you have specific questions regarding this software, please contact the eSub team by email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your comments and suggestions to the eSub
team as often as you like.
Thank you for your continued support of the FDA Electronic Submission Program (eSub).

Definitions
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Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing, assembling,
or importing of electronic products (21 CFR1000.3(n)). Manufacturers of electronic products subject
to 21CFR1000-1050 must:

• Design and manufacture their products to be in
compliance with applicable performance standards;
• Test their products to assure compliance;
• Certify compliance of their products;
• Maintain test and distribution records and a file of
correspondence concerning radiation safety, safety
complaints, and inquiries;
• Use the published reporting forms or electronic
software application to submit reports to CDRH,
including Product reports describing the manner of
compliance of the product design and testing
program and Annual Reports summarizing their
compliance testing;
• Report accidental radiation occurrences (i.e.,
possible, suspected,or known exposures);
• Report any radiation defects or noncompliances;
and
• Recall (i.e., repair, replace, or refund the purchase
price of) defective or noncompliant products.
Importers

Importer is any person of organization engaged in the business of importing electronic products. An
importer is considered to be a manufacturer. The requirements for Manufacturers given above also
apply to importers if the requirements have not been done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
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 as provided in section 536(d) of the Radiation Control
for Health and Safety Act of 1968 (21U.S.C. 360mm(d)) and this section. The agent maybe an
individual, a firm, or a domestic corporation. For purposes of this section, any number of
manufacturers may designate the same agent.

From The Federal Food, Drug, and Cosmetic ActSec 536 [21 U.S.C. 360mm](d)
Designation of agent for purposes of service
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3630 Sunlamp Product rpt (OMB 0910-0025)
It shall be the duty of every manufacturer offering an electronic product for importation into the
United States to designate in writing an agent upon whom service of all administrative and judicial
processes, notices, orders, decisions, and requirements may be made for and on behalf of said
manufacturer, and to file such designation with the Secretary, which designation may from time to
time be changed by like writing, similarly filed. Service of all administrative and judicial processes,
notices, orders, decisions, and requirements may be made upon said manufacturer by service upon
such designated agent at his office or usual place of residence with like effect as if made personally
upon said manufacturer, and in default of such designation of such agent, service of process,
notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial
proceeding for enforcement of this part or any standards prescribed pursuant to this part may be
made by posting such process, notice, order, requirement, or decision in the Office of the Secretary
or in a place designated by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an
electronic circuit in such product.
Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or acts as part of an electronic circuit and (ii)
emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in
clause (A) and which when in operation emits (or in the absence of effect

Role
What is your role?

[L]

Note:

If you are acting as an agent of the actual manufacturer, please select your role as, for example,
perhaps an Importer or Consultant. Later in the report, under Manufacturer Data, you will be
prompted to enter both manufacturer and submitter information.

Information:

The following screen provides several options for you to accurately define what type of eSubmission
you intend to create for FDA. Below are explanations of your options. Please feel free to review this
screen, advance to the next screen and view the picklists, but if you're confused, come back to read
this screen again to be certain you are selecting the correct report or correspondence type you want
to create.

Submission Information
Use the radio buttons to identify the type of submission you are preparing. (Supplements should be prepared using the
same document type as the original submission.) [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Submission is this?
(Supplements should be submitted
selecting the same document type
as the original report.)

(
(
(
(
(

)
)
)
)
)

Radiation Safety Report (Product) Report (21 CFR 1002.10)
Annual Report (21 CFR 1002.13)
Laser Light Show Documents (all relevant documents) (21 CFR 1040.11(c))
Correspondence
Variance Request (General, not Laser Light Show) (21 CFR 1010.4)

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3630 Sunlamp Product rpt (OMB 0910-0025)
( ) Laser Original Equipment/Component Manufacturer Registration (21 CFR
1040.10(a)(3)(ii))
( ) Abbreviated Report (21 CFR 1002.12)
After answering the Submission Type question above, one of the questions below may become active and required (see
the blue dot to the right of the question). If there is an active question, select the appropriate product area or document
type from the question's pick list. [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Product is this Radiation Safety Report about?
[L]
What Type of Product is this Annual Report about?
[L]
What Laser Light Show Document are you filing?
[L]
What Type of Correspondence is this?
[L]
What Type of Product is this Variance Request about?
[L]

FDA or State Inspector
Abbreviated Report Applicability
OEM Laser Applicability

Section: Manufacturer Data
General Information

General Information for Radiological Health
Products
Manufacturers of products subject to performance standards under the Federal Food, Drug, and Cosmetic Act (FFDCA), Chapter V,
Subchapter C - Electronic Product Radiation Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product and Annual reports. This application will
assist manufacturers of electronic products that emit radiation in providing adequate reporting of radiation safety testing and
compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify
Reporting and Notification requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate form (21 CFR 1002.7). This software
application serves the same report responsibility, so long as the submitter or manufacturer prints out the cover letter and sends it in
along with the CD containing the report files. The submitter of the report will receive an acknowledgment letter (or email message)
with the accession number that CDRH assigns to the report. Please reference this accession number in the future when providing
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3630 Sunlamp Product rpt (OMB 0910-0025)
additional information about this model family in either a supplement or the annual report. If a report is incomplete or inadequate
CDRH may reject it and return it for completion. CDRH will not enter a rejected report into our database.

CDRH DOES NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is
the manufacturer's responsibility to certify that their products comply with all applicable standards
(21 CFR 1010 - 1050), based on a testing program in accordance with good manufacturing
practices. Prior to the shipment of products in interstate commerce, 21 CFR 1002 requires the
manufacturer to submit the product and Annual Reports and to comply with all applicable
importation requirements (21CFR 1005). If there are deficiencies, CDRH may disapprove the firm's
quality control and testing program, determine that the product contains a radiation defect, or
determine that the product fails to comply with a standard. CDRH will notify the manufacturer if we
make such a determination. CDRH may require the manufacturer to cease introduction into U.S.
commerce until deficiencies are corrected, and to initiate a corrective action program (21CFR 1003 1004) for products already introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all attachments are PDF files only, and the cover
letter is printed out and included with a real signature. Translate any text that appears in a language other than English into English
in a complete and accurate manner. Keep a copy (save a copy to your hard drive) of the completed report in your records.
Regulatory information is available on the Internet under www.fda.gov/Radiation-EmittingProducts/default.htm. No copyright
exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms, website, or future electronic submissions,
you may direct the comments to [email protected].
A complete Product Report is required for each product model or model family. Product Reports are now more generally referred to
as Radiation Safety Reports to distinguish the Radiological Health submissions from medical device submissions. CDRH suggests
that a complete report on one model of a family be submitted, with a separate Supplemental Report for each of the other models in
the family. The Supplemental Report should respond in detail to the parts of the form where there are differences to report,
referencing the number of the affected item. Items that are unchanged will still appear in the supplement from the original report.
When new models of a product are introduced, if the models satisfy the criteria for an established reporting exemption or if the new
models do not involve changes in radiation emission or performance requirements, then the manufacturer need not report the models
prior to introduction into commerce. Rather, the manufacturer is only required to identify them in the annual report, or in quarterly
updates to the annual report. Quarterly updates to annual reports may be submitted using the Annual Report software included in
this application. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and consistently used. Please use the terms as defined
in Section 1040.10(b) and in the IEEE Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).

Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing, and reviewing the
collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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3630 Sunlamp Product rpt (OMB 0910-0025)
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number."

Manufacturer and Report Information
Confirmation:

This Manufacturer section of this report requests names, addresses, phone numbers, etc. for your
firm, various officials of your firm, consultants who may assist in preparing the report, parent firm (if
any), importer and designated agent (for foreign firms). Some of this information is mandatory and its
absence will prevent you from completing the report submission. Because some of these entries may
be redundant, utilize the 'Contact Address Book' feature so you can save your data and reselect the
entries later and in the future. (See the upload/download buttons in upper right corner of the
screens).
You can check for missing data at any time using the "Missing Data Report" from the "Output" menu
across the top of this application. The Missing Data Report lists all missing responses that are
required (that have the blue dot).

Information:

Attention: Variance Applicants
If you are acting as an agent or consultant for, or on behalf of, or filing for, a company that will be
manufacturing or producing a Class IIIb or IV projector or laser light show or both which require an
approved variance, the following explanations may provide further clarification.
Manufacturer: This is the firm or company who is requesting the variance, will certify the product or
show, and will be the holder and owner of the variance. This is not the agent or consultant who may
be filing this report or Variance request for the manufacturer; that agent may be the submitter,
identified in a later screen.
Responsible Individual: This person works for the Manufacturer and is responsible for compliance of
the projector and/or show. In the case of laser light shows, he or she may be the company president,
CEO, or the laser light show head operator or a manager who oversees the shows.
Reporting Official: This person works for the Manufacturer and is responsible for reports,
recordkeeping, and submitting FDA required documents and correspondence.

Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the performance
standard. This firm develops and maintains the quality control and testing program that is the basis
for the certification of this product. Additionally, this firm usually is the owner of the product design
and manufacturing process design.
Be sure to enter address information for each tab below:

Select the Manufacturer's address from the Establishment Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: ESTABLISHMENT COMPLEX]

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with this
establishment.

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3630 Sunlamp Product rpt (OMB 0910-0025)
Select the Responsible Individual from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
CONTACT COMPLEX]

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing
all aspects of the testing and quality control procedures for certification as reported to FDA in the
product report. Documentation of changes intesting and quality control procedures submitted to FDA
must be signed by this individual.

Select the Reporting Official from Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Report Submitter
Note:

The submitter may be a consulting individual or firm providing assistance in report preparation and
maintenance. Documents or submissions such as this one that are prepared by the submitter must
have an accompanying authorization letter from the manufacturer's reporting official for authenticity.

Select the Submitter from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

[L]

Select the Parent Establishment and Contact from the Contact Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: CONTACT COMPLEX]

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

[L]

Written Agreement
Item: 1 (could contain up to 10 items with none required)
Note:

The manufacturer who is certifying the product being reported is the manufacturer of record. If this
firm is not in the United States, please identify your current Importer(s).

Note:

If any of the required responses below do not apply to your designated agent, enter 'NOT
APPLICABLE' or 'NA.'

Select the Designated Agent from the Contact Address book:
Contact Name
Occupation Title
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3630 Sunlamp Product rpt (OMB 0910-0025)
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
Attach a copy of written agreement with the designated U.S. agent:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Importer
Item: 1 (could contain up to 10 items with none required)
Select the Importer from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Additional Manufacturing Locations
Item: 1 (could contain up to 100 items with none required)
Note:

If any of the products certified in this report are manufactured at locations other than listed in the
Manufacturer Responsiblefor Product Compliance section, then the names, addresses, and FDA
registration numbers should be provided. In addition any codes used on labels to identify a
manufacturing location must be provided. Each factory location must assure all production
procedures are followed identically step by step as provided in this report.If the procedures are not the
same then separate reports should be filed.

Select the Manufacturer Address from the Establishment Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
ESTABLISHMENT COMPLEX]
Code used on identification labels:

Section: Product Data
Product and Model Identification

Attention - Information about this section
In this section you'll be asked to identify several required or optional things which will help
FDA/CDRH staff to prioritize their reviews. You'll be asked to consider the following aspects:
(1) Identify your product's radiation type and the CDRH Product Code.
(2) Enter an Accession number if this will be a report supplment. If you are preparing a supplement, you'll see that after entering a
valid 7-digit Accession number many questions will no longer be required (they will either be disabled or will be optional, meaning
they will no longer have the blue dot).
(3) You will also have several questions that are of high significance for FDA/CDRH - why you might be submitting this report or
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3630 Sunlamp Product rpt (OMB 0910-0025)
correspondence. Please read these questions carefully, referring to the 21 CFR regulations on the website www.FDA.gov if you are
unsure if the question is relevant to your firm's situation.
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't seem to fit under other questions,
we have a final "Additional Information" question in this section which invites you to add comments and/or attach a file that
provides further information from your firm about this submission. This is the place to add that extra information.

Product Type Reported
Note:

Each product that CDRH regulates is assigned a product code by CDRH.

What is the product code?
To select the three letter product code,
- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes from which to
choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code. [QUESTION TYPE NOT YET
IMPLEMENTED: RH SINGLE PRODUCT CODE]
If Other, provide a category name for this specific product.

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the Product Type [L]
Reported section?
Since this is not the first time you've reported on this type of product, then is this a report supplement to a
previously reported model family?

[L]

Provide the Accession Number of the original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here, such as
PMAs, 510(k)s, IDEs, etc. See Accession number description below.)

Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

[L]

If you are requesting a renewal, extension, or amendment, please provide the variance number that was
issued by CDRH.
Stop:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance
Request separate from this report. To do this, open a new report (File > New) and select either
"Laser Light Show Variance Request" or "Variance Request (General, not Laser Light Show)" as your
Type of Submission in the Submission Information Screen. If you select "Variance Request (General,
not Laser Light Show)r" you must select the product for which you are requesting a variance with the
pick list in the bottom section of the screen.

Special Considerations
Note:

Check all items in this section that may apply to this submission.

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Information:

If this product will require a formally approved Variance from a certain performance requirement, you
will need to complete two Reports for FDA, both (1) this Radiation Safety Report (RSR) on this
product, and (2) a Variance Request report. This eSubmitter software application package includes a
general Variance Request form as well as the specific Laser Light Show Variance Request form.
Both the Product RSR file and the appropriate Variance Request Correspondence file must be
submitted to CDRH following the regular files packaging procedures in this application. Both may be
transferred to the same CD or submitted via the FDA ESG to submit to the FDA/CDRH.
In addition, any Variance Request form must be printed out and the signed hard-copy sent to FDA's
Division of Dockets Management at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
NOTE: There is no need to send a copy of the CD to Division of Dockets Management.

Noncompliances or Defects
Does this document or any of its attachments contain:
A notification of noncompliance or defect?

[L]

You may provide an explanation and/or attach a document here:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Responses to Noncompliances or Defects
Does this document or any of its attachments contain any of these responses concerning noncompliances or defects?
A refutation of noncompliances or defects identified to your firm?

[L]

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

[L]

Corrective action plans you intend to implement to correct noncompliances or defects discovered in past or
current production?

[L]

Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information on
design changes for future production, the design change information must be submitted in a Radiation
Safety (Product) Report or supplemental report. Both the proposed CAP and the design changes
may be submitted in one document if you prepare a product report and choose to include the CAP in
it as a file attachment. Alternatively, you may create a separate eSubmission for the CAP using the
"Correspondence" type template and selecting "Follow-up correspondence to FDA."

A description of any design changes that correct noncompliances for future production?
Note:

[L]

If you are submitting information on product design changes for future production due to a discovery
of noncompliances or defects in current production, you must use the Radiation Safety (Product)
Report template to create the report . Correspondence templates may be used to submit other
information such as a proposed corrective action plan pertaining to a noncompliance or defect.

You may add an explanation and/or attach a document here:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

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Details

[HTML Text]

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (21 CFR 1010.5)?

[L]

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

[L]

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

[L]

Request for approval of alternate labeling?

[L]

Application for alternate test procedures (21 CFR 1010.13)?

[L]

You may provide an explanation and/or attach any relevant documents here:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Variance Requests
Information:

Please note: in addition to responding to these questions below, a separate General Variance
Request or Laser Light Show Variance Request form must be completed and submitted to CDRH,
with a hard copy sent to FDA's Division of Dockets Management as instructed below for any variance
request. The information requested on this screen does not constitute the full structured content of
the variance request. The 2 types of Variance forms can be created in eSubmitter by selecting the
appropriate Variance submission type under the eRad Health Menu section of this application.

Message:

Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.
Item 1
Item 2
Item 3
Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details

[HTML Text]

File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv,
.zip)]

Stop:

For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission instructions
located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual. If sending
a CD & submittal letter, please mail to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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Additionally, a paper version (hard-copy) of the signed Variance request document should be
submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an FDA inspection?

[L]

What was the date of the inspection?

[Date]

A response to a Warning letter or a Notification of Noncompliance or Defect from the FDA?

[L]

What was the date of the Warning Letter or other notification letter?

[Date]

A response to a report review inquiry from the CDRH (the inquiry may have been in the form of a letter,
email, or phone call)?

[L]

What was the date of the inquiry?

[Date]

A response to any other communication from FDA?

[L]

What was the date of the communication?

[Date]

Provide an explanation:
[Multi-Line Plain Text]

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!
Is there any other relevant information or additional comments that would help expedite the review of this submission?
Click the plus sign below to attach any supporting files.
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Private Labeling
Is the product sold by other companies under different brand names?

[L]

Private Labeling-Table
Item: 1 (could contain up to 20 items with 1 required)
Give the name and address of the manufacturer:
Establishment Name
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3630 Sunlamp Product rpt (OMB 0910-0025)
Division Name
Email Address
Address
Telephone Number
Fax Number
Give the firm establishment registration number of the manufacturer listed above (if
known):
Enter brand names and/or model designations in the following table by clicking on the Add button. If you prefer to attach
a file, please click on the Add button and enter the text "See File Attachment" as the first table entry.
Item 1
Item 2
Item 3
List of Brand Names and/or Model Designations
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The Original Equipment Manufacturer (OEM) accession number (if known):
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these
numbers has been assigned by FDA yet.
[Multi-Line Plain Text]
If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please provide an
explanation. The device regulations can be found in 21 CFR 807 - device manufacturer registration and device listing.
[Multi-Line Plain Text]
Note:

See also http://www.fda.gov/MedicalDevices/default.htm for more information on medical device
premarket clearance procedures.

Section: Sunlamp Product
Part 1 Product Type and Identification
Is this a report on products that incorporate sunlamps/ultraviolet lamps?

[L]

Is the product type a:

[L]

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3630 Sunlamp Product rpt (OMB 0910-0025)
If "Other" has been selected, please specify further.
Is this a report on an ultraviolet lamp?

[L]

Is the product type a:

[L]

If "Other" has been selected, please specify further.

Part 2 Sunlamp Product Description
Attach a description of the sunlamp product. The description must include the following:
(1) exterior and interior structures of the assembled product;
(2) description and manufacturer's specification for the reflector, timer, filters, ultraviolet lamps, ballasts, etc.;
(3) photographs and diagrams which include parts identification;
(4) electrical circuit diagram
Click on the Add... button below to attach the files.
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Ultraviolet Lamps Part I
Item: 1 (could contain up to 500 items with 1 required)
Lamp Manufacturer: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT COMPLEX]
Model Designation (Name and/or Number):
Item
Item 1

Item 2

Type of base or socket used for each ultraviolet lamp in the product (no single
contact medium screw, or double contact medium screw lamp holders):

[L]

If "Other" has been selected, please specify further.

Timer
Timer [21 CFR 1040.20(c)(2)]:
Select the timer type:

[L]

Maximum timer interval (in minutes):
Minimum timer interval (in minutes):
Can the timer be reset before the end of the preset time interval?

[L]

If "No" has been selected, please explain further.
[HTML Text]
What is the maximum timer interval error as a percent of that interval?

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3630 Sunlamp Product rpt (OMB 0910-0025)
What is the maximum recommended exposure time indicated on the label required
by 21 CFR 1040.20(d)(1)(iv) (in minutes)?
If the timer is operated using a token or credit card, what mechanism assures that (1) the maximum recommended
exposure time is not exceeded and (2) the recommended multiple exposure time intervals are included?
[HTML Text]
When radiation emission from a sunlamp product has been terminated for any
reason, including termination by a timer, is resumption of such emission possible
without manualactivation by the user?

[L]

Please explain further:
[HTML Text]
Describe the control on the sunlamp product that enables the user to manually terminate radiation emission at any time
without disconnecting the electrical plug or removing the lamp [21 CFR 1040.20(c)(3)].
[HTML Text]
Where is the location on the sunlamp product of the control described above?

Protective Eyewear
Protective eyewear [21 CFR 1040.20(c)(4)]:
Manufacturer of protective eyewear: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT COMPLEX]
Model Designation Number:
Number of sets of protective eyewear supplied with the sunlamp product:
Message:

Provide the spectral transmittance in the following wavelength ranges:

200-320 nm (as a percent):
320-400 nm (as a percent):
More than 400 nm (as a percent):
Please attach spectral transmittance measurements:
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Can the user see clearly enough while wearing the protective eyewear to reset the
timer?

[L]

If "No" has been selected, explain why.
[HTML Text]

Sunlamp Product Labeling
Submit copies or accurate reproduction of the following labels along with a photograph or drawing showing the location
(on the product) of the required labels.
a. Certification label (21 CFR 1010.2)
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3630 Sunlamp Product rpt (OMB 0910-0025)
b. Identification label (21 CFR 1010.3)
c. Warning label (21 CFR 1040.20(d)(l))
See http://www.fda.gov/cdrh/radhlth/sunlamp.html (see Notices to Industry)
Note: Click on the plus sign below to select the file(s) to attach to this question.
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Provide the data and calculations used to determine the maximum recommended exposure time and exposure schedule
in accordance with the "Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products" dated August
21, 1986. See http://www.fda.gov/cdrh/radhlth/sunlamp.html (see Notices to Industry).
Note: Click on the plus sign below to select the file(s) to attach to this question.
File Attachment

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Ultraviolet Lamp Labeling
Are the ultraviolet lamps incorporated in your product labeled as required by 21 CFR 1040.20(d)(2)?

[L]

If "No" has been selected, explain why.
[HTML Text]
Submit copies or accurate reproduction of the following labels along with a photograph or drawing showing the location
(on the product) of the required labels.a. Certification label (2 1 CFR 1010.2)b. Identification label (21 CFR 1010.3)c.
Warning label (21 CFR 1040.20(d)(2)).
Note: Click on the plus sign below to select the file(s) to attach to this question.
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User Instructions
Submit copies of all instructions that you provide to the users [21 CFR 1040.20(e)(l)] .
Note: Click on the plus sign below to select the file(s) to attach to this question.
File Attachment

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Part 3 Ultraviolet Lamps
Model Designation (Name and/or Number):
Item
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3630 Sunlamp Product rpt (OMB 0910-0025)
Item 1

Item 2

In an attachment, describe the ultraviolet lamp, including design specifications and a picture or diagram.
Note: Click on the plus sign below to select the file(s) to attach to this question.
File Attachment

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Type of base on the lamp:
[HTML Text]

Ultraviolet Lamps Part II
Item: 1 (could contain up to 500 items with 1 required)
Manufacturer:
Model Designation (Name and/or Number):
Item
Item 1

Item 2

Replacement Lamps
Item: 1 (could contain up to 500 items with 1 required)
Model Designation (Name and/or Number):
Item
Item 1

Item 2

Lamp Compatibility
Provide the data and calculations used to determine lamp compatibility (equivalency). See
http://www.fda.gov/cdrh/radhlth/sunlamp.html (see Policy on Lamp Compatibility).
Note: Click on the plus sign below to select the file(s) to attach to this question.
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Provide specifications which document equivalency (identical lamp) between manufacturer's brandand private label(s).
Note: Click on the plus sign below to select the file(s) to attach to this question.
File Attachment

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3630 Sunlamp Product rpt (OMB 0910-0025)
Ultraviolet Lamp Labeling
Submit a copy or facsimile of the following labels required by the performance standard.
a. Cenification label (21 CFR 1010.2)
b. Identification label (2 1 CFR 1010.3)
c. Warning label [2 1 CFR 1040.20(d)(2)]
See http://www.fda.gov/cdrh/radhlth/sunlamp.html (see Notices to Industry)
Note: Click on the plus sign below to select the file(s) to attach to this question.
File Attachment

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Identify the location of each required label on the product and packaging.
Certification Label:
Location on product:
Location on packaging:
Identification Label:
Location on product:
Location on packaging:
Warning Label:
Location on product:
Location on packaging:

User Instructions
User instructions [21 CFR 1040.20(e)(2)]:
Submit a copy of the user instructions that you provide to the users.
Note: Click on the plus sign below to select the file(s) to attach to this question.
File Attachment

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Details

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Part 4 Emission Characteristics
Spectral characteristics:
Message:

Description of procedures for spectroradiometric measurement.

At what distance from the product were the spectral irradiance mesurements made?
(in meters)
Message:

What spectral irradiance standards were used?

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3630 Sunlamp Product rpt (OMB 0910-0025)
−

Source of standard:

−

When last calibrated:

−

Uncertainty:

At what wavelengths was the spectral irradiance of the product measured?
Attach a graphical plot of the spectral irradiance from the product in the 200-710 nm wavelength range. Plot should be
on a semilog graph with the spectral irradiance on the logarithmic scale.
Note: Click on the plus sign below to select the file(s) to attach to this question.
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Irradiance Values
Provide the irradiance values per nanometer (Wattlcm2/nm) over the wavelength range of 200 to 400 MI. See
http://www.fda.gov/cdrh/radhlth/sunlamp.html for Spectroradiometric Measurement, Testing Procedures, and Policy on
Maximum Timer Interval and Exposure Schedule for Sunlamp Products. This document provides the formula and
weighting factors to determine the exposure schedule and maximum recommended exposure time.
Note: Click on the plus sign below to select the file(s) to attach to this question.
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Irradiance ratio [21 CFR 1040.20(c)(l)] :
Watts per cm2 (200-260 nm) divided by Watts per cm2 (260-320 nm):
Watts per cm2 (260-320 nm) divided by Watts per cm2 (320-400 nm):
Describe the equipment and procedures used for spectral irradiance measurements. Include diagrams of light path,
position, make, model, and type of various optical equipment and electronics used.
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Provide the uncertainties for the spectroradiometric measurements in the wavelength range of 200 to 400 nm.
File Attachment

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Describe how you estimated the uncertainties within the specified wavelength range.
File Attachment

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Part 5 Quality Control Testing
Note:

NOTE: Section 21 CFR 1010.2(c) requires that certification be based on tests in accordance with the
standard or on a testing program in accordance with good manufacturing practices (21 CFR 820).
Failure to maintain an adequate testing program will result in disapproval of the program by CDRH.

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3630 Sunlamp Product rpt (OMB 0910-0025)
Preproduction and incoming parts test:
Describe all design and engineering tests conducted on the product.
File Attachment

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Describe all tests and/or checks made on incoming parts, including filters, reflectors, timers, ballasts, and lamps, prior to
their acceptance to ensure that the final product complies with the performance standard for sunlamp products (21 CFR
1040.20).
File Attachment

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Quality control tests or checks made during and after manufacture:
Describe the tests or checks conducted during or after manufacture that ensure compliance with the standard for the
following:
(a) timer functioning and accuracy (at multiple intervals, including maximum);
(b) irradiance ratio;
(c) protective eyewear transmittance;
(d) means to terminate exposure;
(e) warning label;
(f) identification label;
(g) certification label;
(h) user instructions - adequacy and presence;
(i) presence and quantity of protective eyewear;
(j) other
Include detailed descriptions of all sampling plans, instrumentation (including calibration), test procedures (including inprocess and finished product quality control inspections), and rejection criteria used.
File Attachment

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Submit copies of all written quality control test procedures and check sheets (demonstrating actual test results) used for
incoming component tests, manufacturing tests, and final acceptance tests.
File Attachment

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Part 6 Life and Reliability Testing
Attach information for all life and reliability tests on the product and its components, as required by 21CFR
1002.30(a)(3). If any life tests are done on an accelerated aging basis, so indicate and provide details of the procedures
and the formula or factors used in the accelerated tests. Provide this information (including results, data and/or condition
of component at each inspection or test interval) for the following tests:
(a)
(b)
(c)
(d)
(e)

timer;
irradiance ratio;
protective eyewear;
means to terminate emission control;
warning label;

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3630 Sunlamp Product rpt (OMB 0910-0025)
(f) certification label;
(g) identification label;
(h) mechanical durability;
(i) electrical durability;
(j) filters;
(k) reflectors;
(l) others
File Attachment

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Stop:

You have reached the end of this report. Please verify that all PDFs that are to be included in this
submission are correctly attached to a specific file attachment question. Otherwise, they will not be
packaged with your report. Check to make sure you have no missing data (select Missing Data
Report from the Output menu). Once you have confirmed that there is no missing data and all your
files are attached, click on the Package Submission icon on the tool bar.

Message:

Form FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products
(10/31/2013)

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Created By: eSubmitter on 6/10/2013 at 3:10 PM

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