FDA 3646 Mercury vapor lamp (esubmitter)

Submission Report

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Submission Report
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

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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/RadiationEmittingProducts/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).
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. The OMB control number for
this information collection is 0910-0025 (expires January 31, 2017).
Role
What is your role?
Information:

!* Manufacturer

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
Step 1

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.)

What Type of Submission is this? (Supplements should be submitted
selecting the same document type as the original report.)

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!* (•) 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

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( ) Variance Request
(General, not Laser Light
Show) (21 CFR 1010.4)
( ) Laser Original
Equipment/Component
Manufacturer Registration
(21 CFR 1040.10(a)(3)(ii))
( ) Abbreviated Report
(21 CFR 1002.12)
Step 2

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.

What Type of Product is this Radiation Safety Report about?

!*

High Intensity Mercury Vapor Discharge and Metal Halide Lamps
What Type of Product is this Annual Report about?
What Laser Light Show Document are you filing?
What Type of Correspondence is this?
What Type of Product is this Variance Request about?

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Manufacturer Data
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:

*

Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

Responsible Individual
Note:

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

Select the Responsible Individual from the Contact Address book:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number

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Mailing Location:
Address
Telephone Number
Fax Number

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:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

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:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name

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Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number
Comments:
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

*

Select the Parent Establishment and Contact from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

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?

*

Importer

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Additional Manufacturing Locations

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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 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
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.
Category
Product Code
Performance
Standard
If Other, provide a category name for this specific product.

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Report Information
Is this the first time you've submitted a report on the particular type of product selected
in the Product Type 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?
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?
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

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?

*

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

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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?

*

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

*

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

*

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 "Followup correspondence to FDA."

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

*

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:
Details

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)?

*

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

*

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

*

Request for approval of alternate labeling?

*

Application for alternate test procedures (21 CFR 1010.13)?

*

You may provide an explanation and/or attach any relevant documents here:

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.

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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

No Information Provided.

Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details
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
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?

*

What was the date of the inspection?
A response to a Warning letter or a Notification of Noncompliance or Defect from the
FDA?

*

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

*

What was the date of the inquiry?
A response to any other communication from FDA?

*

What was the date of the communication?
Provide an explanation:

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!

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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.
Details

Private Labeling
Is the product sold by other companies under different brand names?

*

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.

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.

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Mercury Vapor Lamp Products
Lamp Type
Specify the type of lamp being reported.

*

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

Product Identification
Note:

Report the model name and/or number, model family, brand name, or other designation of
the product. If reporting a model family, provide the model designation of each model. If you
do not have a model family or brand name, leave the field blank.

Enter the Model Designation (Names and/or Numbers):
Item

Model Name

Family Name

*
Brand Name

Product Description
Provide a description of the exterior including information on the base or socket of the reported model.
The descriptions may include the photographs or drawings with dimension reference scale. Click on the
Add... button below to add and select the files to be attached.

*

Details
Provide a description of the interior structures of the reported model. The description may consist of
photographs or drawings of the interior structures with parts and component identification and with scale
dimensions. Click on the Add... button below to add and select the files to be attached.

*

Details

Description of Operation
Provide a brief general description of the theory and process of operation including the start, warmup,
and the steady-state condition of the reported model.

*

Details
Provide information on lamp starting voltage, and operating current of the reported model (reference
may be made to ANSI standard).

*

Details
Specify the type of ballast that meets the specifications of the reported model's ratings for starting and
operation (reference may be made to ANSI standard).

*

Details
Provide information on the life and warm-up time of the lamp.

*

Details

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If the reported model is a self-extinguishing lamp, provide descriptions in detail of the self- extinguishing
mechanism including its functioning theory and the conditions under which it renders the lamp inoperable.
Details

General Labeling Requirements
Does the reported lamp model have a label certifying that the lamp conforms to the provisions of 21
CFR 1040.30 as required by 21 CFR 1010.2?

*

Where is the certification label?
Submit a sample of the required certification label for the reported model, or a facsimile of the label if the label
is inscribed on the lamp.
Details
If no, provide an explanation.
Does the reported lamp model have an identification label that conforms to the provisions of 21 CFR
1010.3?

*

Where is the identification label?
Submit a sample of the required certification label for the reported model, or a facsimile of the label if the label
is inscribed on the lamp.
Details
How is the identification label permanently affixed, inscribed or marked on the lamp and/or the lamp
packaging?
If no, provide an explanation.
Is the reported lamp model permanently labeled or marked in such a manner that the name of the
manufacturer and the month and year of manufacture of the lamp can be determined on the intact
lamp and after the outer envelope is broken or removed?

*

Attach a facsimile of the above identification label or mark for the reported model.
Details
How are the name of the manufacturer and the date of the manufacture permanently labeled or marked on
the lamp?
If the name of the manufacturer and month and year of manufacture are expressed in code or symbols, you
must provide the translation or explanation.
Item

No Information Provided.

Provide the location of the coded information or symbols (please attach a picture, drawing, or diagram
showing location).
Details

Requirements for Non-Self-Extinguishing Lamps
Note:

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This part should be completed when reporting non-self-extinguishing types of high intensity
mercury vapor discharge lamp as defined in 21 CFR 1040.30 (b) (1).

Lamp Labeling
Is the reported lamp model clearly marked with the letter R on the outer envelope?
Provide an explanation as a file attachment or text in the box below.
Details
Does the reported lamp model have the letter R also marked on another part of the lamp?
Provide an explanation as a file attachment or text in the box below.
Details
Identify the location of the letter R. Attach a picture, drawing, or diagram showing the location.
Details
How is the letter R marked on the lamp?
Is the letter R visible after the outer envelope of the lamp is broken or removed?
Provide an explanation as a file attachment or text in the box below.
Details

Lamp Packaging
Does the lamp packaging for the reported lamp model clearly and prominently display the letter R?
Provide an explanation as a file attachment or text in the box below.
Details
Does the lamp packaging for the reported lamp model clearly and prominently display the following
warning? WARNING: This lamp can cause serious skin burn and eye inflamation from shortwave ultraviolet
radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more
than a few minutes unless adequate shielding or other safety precautions are used. Certain types of lamps
that will automatically extinguish when the outer envelope is broken or punctured are commercially
available.
Provide an explanation as a file attachment or text in the box below.
Details
The required warning statement for a non-self-extinguishing lamp
appears on the following location(s) for the reported model(s):

[ ] Lamp Carton
[ ] Outer Wrapping
[ ] Other Means of Containment

If Other Means of Containment was selected, please specify further.
Attach a sample or facsimile of the label on lamp packaging as required by 1040.30 (e) (2) for the reported
model.
Details
Describe other radiation safety related information, if any, provided on or with the lamp packaging for the
reported model and the reason for providing that information.

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Lamp Advertisement
Does the advertising for the reported model prominently display the following warning statement?
WARNING: This lamp can cause serious skin burn and eye inflamation from shortwave ultraviolet radiation
if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a
few minutes unless adequate shielding or other safety precautions are used. Certain types of lamps that will
automatically extinguish when the outer envelope is broken or punctured are commercially available.
Provide an explanation as a file attachment or text in the box below.
Details
The required warning statement in advertisement for a non-self-extinguishing
lamp is included in:

[ ] The Catalog
[ ] Specification Sheet
[ ] Price List
[ ] Other Description or
Commercial Brochure and
Literature

If Other Description or Commercial Brochure and Literature was selected, please specify further.
Attach copies of all advertisements containing the warning label as required by 1040.30 (e) (3) for the
reported model (material may be submitted in draft form as long as it is marked as a draft and final copies are
to be submitted as report supplements when available.) Click on the Add button below to add and select files
to be attached.
Details
Describe other radiation safety-related information, if any, provided in advertisement for the reported model
and the reason for providing that information.

Quality Control Tests for Non-Self-Extinguishing Lamps
Note:

This part should be completed by manufacturers of non-self-extinguishing types of high
intensity mercury vapor discharge lamps as defined in 21 CFR 1040.30 (b) (1).

Quality Control Tests
What tests or checks are conducted to assure the presence of the required labels and markings prior to and
after completion of the manufacturing process? Click on the Add button below to add and select files to be
attached.
Details
Action Upon Rejection
Describe actions to be taken for rejected units and rejected lots. Click on the Add button below to add and
select files to be attached.
Details

Requirements for Self-Extinguishing Lamps
Note:

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This part should be completed when reporting self-extinguishing types of high intensity
mercury vapor discharge lamps as defined in 21 CFR 1040.30 (b) (1) and (7).
Maximum Cumulative Operating Time
The reporting lamp model is designed to cease operation within a cumulative operating time not
to exceed ______ minutes, following complete breakage or removal of the outer envelope (with
no fragment of the outer envelope extending more than 50 millimeters from the base shell.)
Provide the number of minutes.
The reported lamp model is designed to cease operation within a cumulative operating time not
to exceed ______ minutes, following breakage or removal of at least three square centimeters
of continguous surface of the outer envelope. the outer envelope (with no fragment of the outer
envelope extending more than 50 millimeters from the base shell.) Provide the number of
minutes or indicate NA if not applicable.

Lamp Labeling
Is the reported lamp model clearly marked with the letter T on the outer envelope?
Provide an explanation as a file attachment or text in the box below.
Details
Does the reported lamp model have the letter T on another part of the lamp?
Provide an explanation as a file attachment or text in the box below.
Details
Identify the location of the letter T. Attach a picture, drawing, or diagram showing the location.
Details
How is the letter T marked on the lamp?
Is the letter T visible after the outer envelope of the lamp is broken or removed?
Provide an explanation as a file attachment or text in the box below.
Details

Lamp Packaging
Does the lamp packaging for the reported lamp model clearly and prominently display the letter T?
Provide an explanation as a file attachment or text in the box below.
Details
Does the lamp packaging for the reported lamp model clearly and prominently display the words:
This lamp should self-extinguish within 15 minutes after the outer envelope is broken or punctured. If such
damage occurs, TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous shortwave
ultraviolet radiation?"
Provide an explanation as a file attachment or text in the box below.
Details
The required warning statement for a self-extinguishing lamp appears
on the following location(s) for the reported model(s):

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[ ] Lamp Carton
[ ] Outer Wrapping
[ ] Other Means of Containment

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If Other Means of Containment was selected, please specify further.
Attach a sample or facsimile of the label on lamp packaging as required by 1040.30 (d) (3) for the reported
model.
Details
Describe other radiation safety related information, if any, provided on or with the lamp packaging for the
reported model and the reason for providing that information.

Quality Control, Life, and Reliability Tests (Self-Extinguishing Lamps)
Note:

This part should be completed by manufacturers of self-extinguishing type of high intensity
mercury vapor discharge lamp as defined in 21 CFR 1040.30(b) (7). Wherever appropriate,
information attached should include quality control procedures for the tests performed,
parameters measured, physical conditions under which tests are conducted, measurement
instrumentation and techniques, uncertainty evaluations of the measurements, sampling
plans, the rejection criteria or confidence limits used, and the justification for the particular
choice of such limits, methods of data analysis, etc.

Quality Control Tests
Quality control tests conducted before the lamp is manufactured:
What tests were conducted on preproduction or prototype models prior to initiation of manufacturing to assure
that the lamp was adequately designed for compliance within the performance standard? Click on the Add...
button below to add and select the necessary files to be attached.
Details
What tests are conducted on the components of the self-extinguishing mechanism of the lamp prior to their
incorporation into the lamp? Click on the Add... button below to add and select the necessary files to be
attached.
Details
Quality control tests done during and after manufacture of the lamp:
What tests or checks are conducted on the components of the self-extinguishing mechanism of the lamp prior
to their incorporation into the lamp? Click on the Add... button below to add and select the necessary files to
be attached.
Details
What tests or checks are conducted to assure proper functioning of the self-extinguishing mechanism after
completion of the manufacturing process? Click on the Add... button below to add and select the necessary
files to be attached.
Details
What tests or checks are conducted to assure the presence of the required labels and markings prior to and
after completion of the manufacturing process? Click on the Add... button below to add and select the
necessary files to be attached.
Details

Action Upon Rejection

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Submission Report

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Describe actions to be taken for rejected units and rejected lots if they have been rejected for problems
concerning compliance with 21 CFR- 1040.30. If retesting is required, state the criteria and procedures for
retesting. Click on the Add... button below to add and select the necessary files to be attached.
Details

Life and Reliability Tests
Provide descriptions of the life and reliability tests of the self-extinguishing mechanism of reported model,
including testing procedures, accept or reject criteria, lot and sample size and action following rejection. Click
on the Add... button below to add and select the necessary files to be attached.
Details

Results of Tests
Identify the type of tests related to compliance with 21CFR 1040.30 for which results are presented including
reference to applicable portions of this part of the report as appropriate. Click on the Add... button below to
add and select the necessary files to be attached.
Details
Identify the time period represented by results presented for each test. Click on the Add... button below to add
and select the necessary files to be attached.
Details
Provide information on the total number of units manufactured or received in the case of components, the
number of units tested, and the number of units that initially failed to meet the quality control acceptance
criteria for each test related to compliance with 21 CFR 1040.30. Click on the Add... button below to add and
select the necessary files to be attached.
Details
Stop:

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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.

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