Form CDPH 72N New Medical Device Manufacturing License Application - California

Form CDPH72N is a California Department of Public Health form also known as the "New Medical Device Manufacturing License Application". The latest edition of the form was released in April 1, 2018 and is available for digital filing.

Download an up-to-date Form CDPH72N in PDF-format down below or look it up on the California Department of Public Health Forms website.

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State of California—Health and Human Services Agency
California Department of Public Health
Food and Drug Branch
NEW MEDICAL DEVICE MANUFACTURING LICENSE APPLICATION
PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED
See page 2 for instructions
NEW APPLICANT
RELOCATION
OWNERSHIP CHANGE
OWNERSHIP AND LOCATION CHANGE
1. Legal Name of Firm
9. Facility Operator (name and title)
2. DBA (List additional DBA’s on separate sheet if necessary.)
10. Facility Telephone Number
11. Facility FAX Number
(
)
(
)
3. Facility Address (number, street)
12. 24-Hour Emergency Telephone Number 13. E-mail Address
(
)
4. Facility Address (continued)
14. Correspondent (name and title)
5. City
State
ZIP Code
15. Correspondent Telephone Number
16. Correspondent FAX Number
(
)
(
)
6. Mailing Address (if different or P.O Box number)
17. County
7. Mailing Address (continued)
18. Website (URL)
8. City
State
ZIP Code
19. Interstate Commerce
Product Shipped
Product or Raw Materials Received
N/A
Type of Ownership:
20.
Individual/Sole Proprietorship
Partnership
Corporation/Limited Liability Company
Nonprofit
Other:_____________________
21. Corporate Name (if applicable)
State of Incorporation
22. Owners’ or Officers’ Names and Titles
Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)
Previous California Department of Public Health – Food and Drug Branch License Number(s):
___________________
___________________
23.
Manufacturer
Contractor
Component
Specification Developer
Other:_______________
24. Type of Manufacturing Business (check all that apply)
Size of Facility (square feet): __________________
Number of Employees at this facility: _____________
Business days and hours: ____________________
25. Stage of Manufacture at Date of Application (check all that apply)
Manufacturing Products
Design Development
Design Validation
Pre-production Design Transfer
Other: ______________
26. Intended Device Destination (check all that apply)
Investigational Studies
Export Market
California Distribution
U.S. Distribution
Other: __________________________
27. Check Each Product Area that Applies to the Devices Manufactured
862 Clinical Chemistry and Clinical Toxicology
874 Ear, Nose, and Throat
886 Ophthalmic
864 Hematology and Pathology
876 Gastroenterology/Urology
888 Orthopedic
866 Immunology and Microbiology
878 General and Plastic Surgery
890 Physical Medicine
868 Anesthesiology
880 General Hospital and Personal Use
892 Radiology
870 Cardiovascular
882 Neurological
872 Dental
884 Obstetrical and Gynecological
28. List the types of classified and/or unclassified manufactured devices in the spaces below. Use additional sheets if necessary.
Classification (Check One)
Federal Classification Title
I
II
III
29. Identify processes employed or planned in the manufacture of the devices listed above and if activities will be done in-house or by contract. Use additional sheets if necessary.
Process/Activities
In-House
Contract
Process/Activities
In-House
Contract
Sterilization
Repackaging/Relabeling
Software Development
Remanufacturing/Refurbishing
Circuit Board Assembly
Tissue/Cell Culture
Lyophilization
Other:
Antigen/Antibodies
30. Payment Code
A—$2,454
(Fee is due at the time application is submitted and is Non-Refundable)
31. Please attach:
Evidence of ownership and one of the following:
A copy of a valid biologics license issued by the U.S. Food and Drug Administration (FDA)
A copy of a valid establishment registration pursuant to Section 510 of the federal act and an attestation that a federal inspection was completed
within the last two years
A copy of documentation demonstrating compliance with audits conducted pursuant to International Organization for Standardization (ISO) ISO
standards (ISO 9000 series, ISO 13485:2003, ISO 15378:2006)
A copy of approved investigational device exemption issued by the FDA
The Food and Drug Branch MUST BE NOTIFIED of any change in the application information as provided by California Health and Safety Code §111630.
By signature, I declare under penalty of perjury that all information provided herein, including any supplemental documentation hereto, is true and
correct.
32. Signature of Applicant
Printed name
Title
Date
PLEASE DO NOT WRITE BELOW THIS LINE.
License Number
Expiration Date
Date Received
Payment Type
Amount
$
Fund 3018
Index 5624
PCA 76211
Receipt Source 125700
Agency Source 0049
Page 1 of 2
CDPH 72N (04/18)
State of California—Health and Human Services Agency
California Department of Public Health
Food and Drug Branch
NEW MEDICAL DEVICE MANUFACTURING LICENSE APPLICATION
PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED
See page 2 for instructions
NEW APPLICANT
RELOCATION
OWNERSHIP CHANGE
OWNERSHIP AND LOCATION CHANGE
1. Legal Name of Firm
9. Facility Operator (name and title)
2. DBA (List additional DBA’s on separate sheet if necessary.)
10. Facility Telephone Number
11. Facility FAX Number
(
)
(
)
3. Facility Address (number, street)
12. 24-Hour Emergency Telephone Number 13. E-mail Address
(
)
4. Facility Address (continued)
14. Correspondent (name and title)
5. City
State
ZIP Code
15. Correspondent Telephone Number
16. Correspondent FAX Number
(
)
(
)
6. Mailing Address (if different or P.O Box number)
17. County
7. Mailing Address (continued)
18. Website (URL)
8. City
State
ZIP Code
19. Interstate Commerce
Product Shipped
Product or Raw Materials Received
N/A
Type of Ownership:
20.
Individual/Sole Proprietorship
Partnership
Corporation/Limited Liability Company
Nonprofit
Other:_____________________
21. Corporate Name (if applicable)
State of Incorporation
22. Owners’ or Officers’ Names and Titles
Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)
Previous California Department of Public Health – Food and Drug Branch License Number(s):
___________________
___________________
23.
Manufacturer
Contractor
Component
Specification Developer
Other:_______________
24. Type of Manufacturing Business (check all that apply)
Size of Facility (square feet): __________________
Number of Employees at this facility: _____________
Business days and hours: ____________________
25. Stage of Manufacture at Date of Application (check all that apply)
Manufacturing Products
Design Development
Design Validation
Pre-production Design Transfer
Other: ______________
26. Intended Device Destination (check all that apply)
Investigational Studies
Export Market
California Distribution
U.S. Distribution
Other: __________________________
27. Check Each Product Area that Applies to the Devices Manufactured
862 Clinical Chemistry and Clinical Toxicology
874 Ear, Nose, and Throat
886 Ophthalmic
864 Hematology and Pathology
876 Gastroenterology/Urology
888 Orthopedic
866 Immunology and Microbiology
878 General and Plastic Surgery
890 Physical Medicine
868 Anesthesiology
880 General Hospital and Personal Use
892 Radiology
870 Cardiovascular
882 Neurological
872 Dental
884 Obstetrical and Gynecological
28. List the types of classified and/or unclassified manufactured devices in the spaces below. Use additional sheets if necessary.
Classification (Check One)
Federal Classification Title
I
II
III
29. Identify processes employed or planned in the manufacture of the devices listed above and if activities will be done in-house or by contract. Use additional sheets if necessary.
Process/Activities
In-House
Contract
Process/Activities
In-House
Contract
Sterilization
Repackaging/Relabeling
Software Development
Remanufacturing/Refurbishing
Circuit Board Assembly
Tissue/Cell Culture
Lyophilization
Other:
Antigen/Antibodies
30. Payment Code
A—$2,454
(Fee is due at the time application is submitted and is Non-Refundable)
31. Please attach:
Evidence of ownership and one of the following:
A copy of a valid biologics license issued by the U.S. Food and Drug Administration (FDA)
A copy of a valid establishment registration pursuant to Section 510 of the federal act and an attestation that a federal inspection was completed
within the last two years
A copy of documentation demonstrating compliance with audits conducted pursuant to International Organization for Standardization (ISO) ISO
standards (ISO 9000 series, ISO 13485:2003, ISO 15378:2006)
A copy of approved investigational device exemption issued by the FDA
The Food and Drug Branch MUST BE NOTIFIED of any change in the application information as provided by California Health and Safety Code §111630.
By signature, I declare under penalty of perjury that all information provided herein, including any supplemental documentation hereto, is true and
correct.
32. Signature of Applicant
Printed name
Title
Date
PLEASE DO NOT WRITE BELOW THIS LINE.
License Number
Expiration Date
Date Received
Payment Type
Amount
$
Fund 3018
Index 5624
PCA 76211
Receipt Source 125700
Agency Source 0049
Page 1 of 2
CDPH 72N (04/18)
New Medical Device Manufacturing License Application Instructions
A separate application is required for each place of business. Please complete and/or amend this application as is most appropriate to your facility. Include the
appropriate fee for each application as indicated in the fee schedule and make payable to: CA DEPARTMENT OF PUBLIC HEALTH. This fee must
accompany this application or the application cannot be processed. Unsigned or incomplete applications cannot be processed. The following are further
instructions on how to complete this application:
New Applicant: Place an (X) in the box next to New Applicant if your firm has not previously applied for a Medical Device Manufacturing License at this
location while under the current ownership. This license is non-transferable. If your firm has changed location, ownership, or both, place an (X) in the box
adjacent to the appropriate response and also in the box next to New Applicant. Any questions that do not apply to your company indicate with N/A. Do not
leave any sections blank.
1. Legal Name of Firm: Enter full name of business, corporation, company, or organization applying for licensure.
2. DBA: Enter any other name(s) your company is doing business as.
3.–5. Facility Address: Enter the number, street, city, state, and ZIP code for this facility location.
6.–8. Mailing Address: Enter the full mailing address if different from the facility or P.O. Box.
9. Facility Operator: Enter the full name of the person who is responsible for the manufacturing of medical devices at this facility and their title.
10. Facility Telephone Number: Enter daytime business telephone number of this facility.
11. Facility FAX Number: Enter facility FAX number.
12. 24-Hour Emergency Telephone Number: Enter telephone number to be called in the event of an emergency.
13. E-mail Address: Enter facility or correspondent’s email address.
14. Correspondent: Enter the name of the person to contact for information regarding this application and their title.
15. Correspondent Telephone Number: Enter the daytime business telephone number of the contact person.
16. Correspondent FAX Number: Enter the daytime business FAX number of the contact person.
17. County: Enter the country where your facility is located.
18. Website: Enter the website address for your business if applicable.
19. Interstate Commerce: Place an (X) in the boxes that correctly describe your business’ receipt or distribution of products or materials through or into
interstate commerce.
20. Type of Ownership: Place an (X) in the box next to the appropriate legal description of the facility’s ownership.
21. Corporate Name: Enter corporate name if applicable. Enter the state of incorporation if applicable.
22. Owner’s or Officer’s Names: List the business owners’ or officers’ names and titles.
23. List previous California Department of Public Health – Food and Drug Branch License Number(s) if applicable.
24. Type of Manufacturing Business: Place an (X) in the box next to each type of manufacturing business conducted at this facility, size of facility,
number of employees, and list business days and hours.
25. Stage of Manufacture: Place an (X) in the box next to the stage of manufacture your products are in at the time of application submission. Check all
that apply.
26. Intended Device Destination: Place an (X) in the box adjacent to the destination(s) for your manufactured products. Check all that apply.
27. Products Manufactured: Place an (X) in the box adjacent to each product that applies to the devices manufactured or to be manufactured.
28. Classified or Unclassified Devices Manufactured: For each medical device product, list the federal classification name and classification category
(I, II, or III) as listed in 21 CFR, Sections 862 to 892.
If not known or if thought to be unclassified, please provide your best description for each device. Use additional sheets if necessary.
29. Manufacturing Processes: Place an (X) in the column adjacent to any indicated processes to identify if they will be done in-house or contracted out.
Leave line blank if the indicated process will not be used in the manufacture of listed devices. List additional processes or methods as needed herein or
on additional sheets, if necessary.
30. Payment Codes: Please submit license fee based on the application type below. (License is valid for one year.)
License
Payment
Application Type
Payment Interval
Fee
Code
New, Relocation or Ownership Change
$2,454
First license only
A
** LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES
31. Attach Evidence of Ownership and U.S. Food and Drug Administration (FDA) or International Organization for Standardization (ISO) Standards
Documents and place an (X) in the appropriate box(es) for the items that you are submitting with this application. For more information regarding this
requirement, please refer to the California Health and Safety Code Section 111635.
32. Sign the application, print your name, print your title, and enter the date. All signatures must be original.
MAKE CHECKS PAYABLE TO: DEPARTMENT OF PUBLIC HEALTH
MAIL APPLICATION AND CHECK TO:
Regular Mail:
California Department of Public Health
Overnight Mail: California Department of Public Health
Food and Drug Branch - Cashier
Food and Drug Branch - Cashier
MS 7602
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95814
Sacramento, CA 95899-7435
If you have questions about this application, please contact the Food and Drug Branch, Medical Device Manufacturing Licensing Desk at (916)
341-7354, (800) 495-3232.
Fund 3018
Index 5624
PCA 76211
Receipt Source 125700
Agency Source 0049
Page 2 of 2
CDPH 72N (04/18)

Download Form CDPH 72N New Medical Device Manufacturing License Application - California

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