Package Description

In this presentation, we will discuss updates at the FDA related to the Agency’s goals and the electronic Submission Template And Resource (eSTAR) Program. We will walk through how to use the FDA website to search through the Medical Device Database for cleared medical devices and other FDA regulated medical devices. Device labeling is reviewed for devices which require premarket submission. The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. We will discuss the labeling requirements per the FDA regulations and other labeling information recommended for specific devices based on device-specific guidance documents and consensus standards.

LEARNING OBJECTIVES

1. Learn about updates at the FDA and Division of Dental and ENT Devices.
2. Learn how to navigate the Medical Device Database to search for FDA Regulated Medical Devices (e.g., 510(k) Database, Registration & Listing Database).
3. Understand the application of Medical Device Labeling and the General Labeling Provisions for medical devices found Parts of Title 21 of the Code of Federal Regulations (CFR), 21 CFR Part 801 in the Instructions for Use of Dental Devices.

Price:

• Members: $15
• Non-members: $30

Continuing Education

ADS is an ADA CERP Recognized Provider.

ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry.

Concerns or complaints about a CE provider may be directed to the provider or to the Commission for Continuing Education Provider Recognition at ADA.org/CERP.

Please email the ADS office at [email protected] or call +1 (410) 571-0003 if you wish to be in contact with the course author/creator(s) with any questions or for clarification of course concepts or for technical assistance in completing the online test.

All participants assume individual responsibility for providing evidence of contact hours of continuing education to the appropriate authorities and for the maintenance of their individual records.

Learn more about ADS’s CE Program & Provider Recognition.

CE Credits: 1.0
Educational Method: Lecture, Recorded, Self-instructional (self-study)
Location: Online
Publication Date: June 2024
Expiration Date: June 30, 2027

Speakers:

Lauren Giles, RAC

Ms. Giles is a Biomedical Engineer in the Dental and ENT Division of OHT1 serving as a lead scientific reviewer since joining the FDA in 2011. Ms. Giles received a Bachelor of Science degree in Biomedical Engineering in 2009 from Georgia Institute of Technology and received her Regulatory Affairs Certification (RAC) in 2017. As a member of the Dental Devices Branch, Ms. Giles has focused her career on the review of dental handpieces, dental operative units, and dental stereotaxic devices. Ms. Giles represents the FDA as a liaison for SubCommittee 4 Dental Instruments for both the American Dental Association Standards for Dental Products and ISO TC 106 Dentistry.

Disclosure: No relevant financial relationships to disclose

Brian Hudson

Brian A. Hudson is the Director of the Arizona Division of Occupational Safety and Health (ADOSH). Brian comes to ADOSH with over 20 years of experience with Construction, Industrial, Mining, and Public safety. Brian holds a Bachelor’s Degree from the University of Phoenix in Organizational Security and Management. He has various Health and Safety certificates and instructor qualifications.

Disclosure: No relevant financial relationships to disclose