Package Description

Update from FDA

In this presentation, we will discuss updates at the FDA related to the goals of the 21st Century Cure’s Act and MDUFA commitments. We will also touch on dental specific initiatives with the Division of Dental and ENT Devices including breakthrough devices, Safety and Performance Guidance and review of consensus standard. Last year we cleared 267 510(k) submissions. To learn more about the FDA clearance process, we will discuss the different types of premarket submission and 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 device 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 document and consensus standards.

Learning Objectives:

1. Learn about Updates at the FDA and Division of Dental and ENT Devices
2. Identify the different types of Premarket Submission and How to Navigate the Medical Device Database to Search for FDA Regulated Medical Devices (e.g., PMA and 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.

Update from OSHA
Overview of OSHA’s health enforcement policies and programs applicable to the healthcare industry, with a focus on the dental industry.

Learning Objectives:

1. Review OSHA’s health enforcement program
2. OSHA standards and enforcement policies applicable to the dental industry

Price:

• Members: $15
• Non-members: $30

Continuing Education

OSAP 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 OSAP office at office@osap.org 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 OSAP’s CE Program & Provider Recognition.

CE Credits: 1.0
Educational Method: Lecture, Recorded, Self-instructional (self-study)
Location: Online
Publication Date: June 2023
Expiration Date: June 30, 2026

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.

Disclosures: No relevant financial relationships to disclose.

Joanna Gorse Mitchell, MSOH, CIH

Joanna Mitchell is an Industrial Hygienist with the U.S. Department of Labor, Occupational Safety and Health Administration (OSHA), Directorate of Enforcement Programs, and Office of Health Enforcement (OHE). Ms. Mitchell works to develop policies and procedures related to the enforcement of OSHA’s health-related standards and compliance assistance. This includes the development of interpretation letters, compliance instructions, and compliance assistance tools. Ms. Mitchell’s subject areas include bloodborne pathogens and other biohazards as well as respiratory protection.

Disclosure: No relevant financial relationships to disclose