- Answers consumer questions and provides information about the manufacturing and distributing of medical devices.
- Enforces rules and regulations for medical device manufacturers and distributors.
- Investigates complaints related to medical devices or refers complaints to the proper regulatory authority.
- Conducts inspections of medical device manufacturers under contract with the U.S. Food and Drug Administration.
- Responds to disasters to ensure that distressed medical devices do not enter or remain in commerce.
- Conducts medical device health fraud investigations.
- Licenses medical device manufacturers and distributors.
Important Notice for Device Distributors and Manufacturers
Rules for Licensing of Device Distributors and Manufacturers
Title 25. Health Services
Part 1. Department of State Health Services
Chapter 229. Food and Drug
Subchapter X. Licensing of Device Distributors and Manufacturers
Effective November 23, 2014, The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), adopted an amendment to §229.434, concerning the licensing of device distributors and manufacturers without changes to the proposed text as published in the May 30, 2014, issue of the Texas Register (39 TexReg 4120). The amendment implements House Bill 1395, 83rd Legislature, Regular Session, 2013, which amended Health and Safety Code, §431.273, exempting persons from licensing as device distributors or manufacturers if the person holds a registration certificate issued under Occupations Code, Chapter 266, Regulation of Dental Laboratories, and engages only in conduct within the scope of that registration. The amendment to §229.434 adds subsection (b) to define new statutory licensing exemption requirements for device distributors and manufacturers. The amendment also renumbers existing subsection (b) as subsection (c) and corrects citations and grammar. The department, on behalf of the commission, did not receive any comments regarding the proposed rule during the comment period.
The amendment is authorized by Health and Safety Code, §431.241, which provides the department with authority to adopt rules to enforce the Texas Food, Drug and Cosmetic Act; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration and enforcement of the Health and Safety Code, Chapter 1001.
Legend: (Final Amendment – No additional changes from proposed version)
Regular Print = Final language incorporating all proposed changes for final adoption
(No change) = No changes are being considered for the designated subdivision
(a) A person is exempt from licensing under §229.435 of this title (relating to Licensure Requirements) if the person engages only in the following types of device distribution:
(1) – (3) (No change.)
(b) A person is exempt from licensing under §229.435 of this title if the person holds a registration certificate issued under Occupations Code, Chapter 266, and engages only in conduct within the scope of that registration.
(c) This section does not exempt a person from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Texas Dangerous Drug Act, Health and Safety Code, Chapter 483; or the rules adopted to administer and enforce those chapters.
Medical Devices – The Case for Quality
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled “Medical Devices – the Case for Quality.” The educational forum is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible to insure compliance with FDA regulations.
Date and Time: The meeting will be held on April 11, 2014 from 8 a.m. to 5 p.m.
Location: The meeting will be held at Wyndham Dallas Suites – Park Central, 7800 Alpha Road, Dallas, TX 75240. Directions and lodging information are available at the FMDIC, Inc. website at http://www.fmdic.org/.
- Direct to Wyndham Dallas Suites – Park Central – 972-233-7600 (choose option 2), please reference group code “04106822FD”.
- Wyndham Worldwide Reservations – 1-800-996-3426. Your attendees must identify themselves as part of the FDA/Medical Device Industry Coalition (FMDIC), Inc. Reference the group code “04106822FD” to receive the Group rate.
- Hotel Website – http://www.wyndham.com/hotels/46502, click on the “Reservations” button and enter arrival and departure information. Click on “Special Rates and Codes” and in the Group Code field, enter “04106822FD” and click “Enter.” Once the code has been entered, select the “Find It” button, and all the available rates will display.
Contact: C. Sue Thomason, CGMP, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, phone: 214-253-5203, FAX: 214-253-5318, email: firstname.lastname@example.org. Or use our Feedback Form.
Transportation: You can fly into Dallas Love Field Airport (DAL, 5 miles away) or the Dallas/Fort Worth International Airport (DFW, 15 miles away). The websites for each airport provide information about ground transportation options.
Continued Education Unites (CEU) or Contact Hours: Texas A&M University, Department of Biomedical Engineering, will provide attendees with the opportunity to obtain certification of attendance upon request on the day of the event. These certificates contain the number of contact hours.
Registration: The registration fee is used to offset expenses of hosting the event, including the venue, continental breakfast, lunch, break refreshments, materials, and audiovisual equipment. Early registration will end on Tuesday, March 11, 2014. Regular registration ends on Friday, April 11, 2014, the day of this event.
|| Early Registration Fee
|| Regular Registration Fee
|Government with ID
|Student with ID
Online registration using Visa, Mastercard, and American Express is available through 123 Signup. Each attendee registers individually using their email address as their unique identifier. Organizations registering multiple individuals with a corporate credit card register each individual using their name and email address. The corporate cardholder enters their corporate credit card information and an additional email address to receive a copy of the credit card receipt.
As an alternative, some send their registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to the ‘FMDIC, Inc.’, to FMDIC Registrar, 4447 N Central Expressway, Suite 110 PMB197, Dallas, Texas 75205. FMDIC accepts registrations onsite on the day of the event beginning at 7:30 AM at the regular registration fee stated in the table above.
Registrants will have the ability to modify their registration information and pre-event survey answers online.
Cancellation Policy: Cancelled registrations are subject to a 10% non-refundable cancellation fee if done no later than April 1, 2014. Registrations are not eligible for cancellation on or after April 1, 2014. Substitutions are possible at no additional charge up to and including the day of the event, April 11, 2014.
Special Accommodations: Special accommodations due to a disability are possible with notification to the Contact Person (above) no later than 14 days before the date of the event.
Dress Code: The dress code is business casual.
Food: Continental breakfast, coffee service, a buffet lunch, and mid-afternoon refreshments are provided.
Materials: Handouts of the presentations are organized in a single Portable Document Format (PDF) file for download: (To be posted prior to the event) This digital document is available to everyone for download at no charge. If your computer does not have a PDF reader, you may wish to install the Adobe Acrobat Reader, a free download. This is a green meeting. We encourage attendees to bring a digital tablet or notebook computer preloaded with the handouts file.
Miscellaneous: The Dallas Convention & Visitors Bureau provided valuable coupons and discounts for our attendees:
- Dining Coupons and Discounts in Dallas
- Retail Coupons and Discounts in Dallas
- Discounts and Coupons to Attractions in Dallas