1. (a) General. A person may not distribute or manufacture devices in Texas unless the person has a valid license from the commissioner for each place of business, unless exempted by §229.434 of this subchapter (relating to Exemptions).
2. (b) Proof of licensure. The license holder must show proof of licensure in a format readily available to the public.
3. (c) Existing place of business. Each person distributing or manufacturing devices in Texas on the effective date of these sections must apply for a device distributor or manufacturer license no later than 60 days following the effective date.
4. (d) New place of business. Each person who acquires or establishes a place of business to distribute or manufacture devices must apply to the department for a license before beginning operations.
5. (e) Two or more places of business. If the device distributor or manufacturer operates more than one place of business, the device distributor or manufacturer must license each place of business separately.
6. (f) Issuance of license. Under §229.281 of this chapter (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may issue a license to a device distributor or manufacturer who meets all applicable requirements and pays all fees as required by §229.439 of this subchapter (relating to Licensure Fees).
7. (g) Transfer of license. A person may not transfer a license to another person or to a different place of business.
8. (h) License term. A license remains valid for two years unless it is amended under subsection (j) of this section or revoked or suspended under §229.440 of this subchapter (relating to Refusal, Cancellation, Suspension, or Revocation of License.

9. (i) Renewal of license.

   1. (1) A person must submit the license application outlined in §229.436(b) of this subchapter (relating to Licensing Procedures) and must pay the nonrefundable license fee for each place of business as outlined in §229.439 of this subchapter before the current license expires. A person who submits a renewal application after the expiration date must pay a $100 delinquency fee.
   2. (2) A licensee who fails to submit a renewal application before the license expiration date and continues to operate may be subject to enforcement and penalties under §229.443 of this subchapter (relating to Enforcement and Penalties) and to revocation or suspension of the license under §229.440 of this subchapter.
   3. (3) The department must issue a renewal license only after receiving all past due fees.
10. (j) Amendment of license. To amend a license, including a name change, or a change in the location of a licensed business, a person must submit an application as outlined in §229.436 of this subchapter and pay the applicable fees as outlined in §229.439 of this subchapter.

11. (k) Notification of change of location of place of business.

    1. (1) At least 30 days before changing the location of place of business, the licensee must notify the commissioner or the commissioner's designee in writing of their intent to change locations of place of business. The notice must include address of new business location; name of person in charge of business at new location; and residence address of person in charge of business at new location.
    2. (2) Within 10 days of completing the move, the licensee must notify the commissioner or the commissioner's designee by submitting an application to verify: change of location; specific date of move; new location; new location's address; name of person in charge of new business location; and residence address of person in charge of new business location.
    3. (3) If the licensee provides the intent and application to the commissioner or commissioner's designee by certified mail (with return receipt requested), the notice will be deemed adequate. The intent and verification notice should be mailed to the department at 1100 West 49th Street, Austin, Texas 78756.
12. (l) Combination products. If the United States Food and Drug Administration determines that a combination product's primary mode of action is that of a device, a distributor or manufacturer of the product is subject to licensure as described in this section.
13. (m) Texas.gov. Applicants may submit initial and renewal license applications electronically at www.texas.gov. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs of processing applications and renewals through the website.

Source Note:The provisions of this §229.435 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147.