Form Cdph 72R – Fill Out and Use This PDF

Biennial Medical Device Manufacturing License Renewal 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. Please apply within 30 days of expiration; failing to do so requires an additional $10 penalty added to the renewal fee before the license is issued. Unsigned or incomplete applications cannot be processed. The following are further instructions on how to complete this application

Renewal Applicant: This license is non-transferable. If your firm has changed location, ownership, or both, use the application titled “New Medical Device Manufacturing License Application” (CDPH 72N). 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 legal 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 address 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 county where your facility is located.

18.Website: Enter the website address for your business.

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.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.

24.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.

25.Intended Device Destination: Place an (X) in the box adjacent to the destination(s) for your manufactured products. Check all that apply.

26.Products Manufactured: Place an (X) in the box adjacent to each product area that applies to the devices manufactured or to be manufactured.

27.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. Refer to the following web sites: http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfrv8_00.html

or http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

If not known or if thought to be unclassified, please provide your best description for each device. Use additional sheets if necessary.

28.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.

29.Payment Codes: Your license fee is based on the application type. The total fee is calculated on a biennial license.

Biennial

Interval of Renewal

Payment

Application Type

*

Late Fee

Fee

and Fees

Code

Renewal

$2600

$10

Biennially on renewal

A

*A $10 late fee is due if your application is over 30 days late.

**LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES

30.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 http://www.leginfo.ca.gov/pub/11-12/bill/asm/ab_1251-1300/ab_1277_bill_20120928_chaptered.pdf

.

31.Sign the application, print your name, print your title, and enter the date. All signatures must be original.

MAKE CHECKS PAYABLE TO: CA 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 any questions about this application, please contact the Food and Drug Branch, Medical Device Manufacturing Licensing Desk at (916) 650-6500 or by email at FDBMedDevice@cdph.ca.gov, or visit our web site at: http://www.cdph.ca.gov/programs/Pages/FDB.aspx.

CDPH 72R (01/13)

Fund 3018 Index 5624 PCA 76211 Receipt Source 125700 Agency Source 0049

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