| Title: |
'What Every EHDI Professional Needs to Know About Regulatory Issues' |
| Track: |
9-Policy, Advocacy, and Legislative Issues
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| Audience: |
Primary Audience:
Audiologist
Secondary Audience:
State Health Department
Tertiary Audeince:
Hospital/Birthing Center<
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| Keyword(s): |
regulatory, claims, clearance, labeling |
| Learning Objectives: |
1. identify the regulatory processes that pertain to technologies used in EHDI systems.
2. analyze information provided about technology claims and regulatory clearance.
3. utilize a series of relevant questions to understand and evaluate medical device options in EHDI programming. |
Abstract: |
Technology is a driving force behind social change in health care systems and has been a major factor in achieving the effectiveness and efficiency necessary for the adoption of universal early detection programs. Increasingly, this topic is being addressed more directly in professional guidelines, ethics policies, and state health agency provider standards. While professionals working within EHDI systems are called upon to evaluate and select technology to provide screening, diagnosis, and amplification, they may have limited acquaintance with the U.S. Food and Drug Administration (FDA),which regulates every medical device in commercial distribution in the United States to ensure that it is safe and effective. As the principal consumer protection agency of the federal government, FDA provides guidelines and establishes regulations that are an important consideration when making technology decisions. This presentation will review those aspects of FDA regulatory oversight that pertain to EHDI, including device claims, the FDA submission and clearance process, exemptions, labeling, Quality Systems, Good Manufacturing Practices, Documentation, and Medical Device Reporting in order to equip professionals with an understanding of these issues and to provide them with information that will be useful in daily practice. |
| Presentation(s): |
Not Available
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| Handouts: |
Not Available
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PRESENTER(S):
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Judith Marlowe - Natus Medical Incorporated
Credentials: B.A. cum laude, Thomas More College, 1969; M.A. University of
Cincinnati, 1971; Ph.D., Walden University,1986.
FAAA, American Academy of Audiology; CCC-A, American Speech-Language-Hearing Association;Florida license, Audiology
Other Affiliations: Executive Director, Audiology & Professional Relations, Natus Medical and Adjunct Honors Professor, Thomas More College (Kentucky)
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Since 1971, initiated audiology programs (hospitals, non-profits, ENT office) and in solely owned private practice. Established 1983 universal newborn screening program; Founding Director, Auditory-Verbal International, 1987-2006, AVI President,1991-1993; Founding Director, AG Bell Academy for Listening and Spoken Language, 2006 -
Publications: twenty-four works in American Journal of Audiology, Seminars in Hearing, Volta Review, Australian Journal of Education of the Deaf, American Annals of the Deaf and contributed book chapters; presentations throughout U.S, Canada, Mexico, Europe, Australia, New Zealand, India, Saudi Arabia,UAE, Japan, Singapore,China.
Honors: Outstanding Young Women of America (5 issues); Who’s Who of Women Executives; Who’s Who in U.S. A. Health Specialists; Who’s Who in America; and Who’s Who Worldwide;Strathmore’s Who’s Who; International Sertoma “Service to Mankind” Award; Marion Downs Award; 2002 Saint Thomas More Medallion/ Commencement Speaker; 2003 Thomas More Professional Achievement Award; University of Cincinnati Communication Disorders Twenty-five Most Prominent Alumni,1989; University of Cincinnati Communication Disorders “2005 Distinguished Alumnus.”
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AUTHOR(S):
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Judith Marlowe - Natus Medical Incorporated
Credentials: B.A. cum laude, Thomas More College, 1969; M.A. University of
Cincinnati, 1971; Ph.D., Walden University,1986.
FAAA, American Academy of Audiology; CCC-A, American Speech-Language-Hearing Association;Florida license, Audiology
Other Affiliations: Executive Director, Audiology & Professional Relations, Natus Medical and Adjunct Honors Professor, Thomas More College (Kentucky)
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BIO: Since 1971, initiated audiology programs (hospitals, non-profits, ENT office) and in solely owned private practice. Established 1983 universal newborn screening program; Founding Director, Auditory-Verbal International, 1987-2006, AVI President,1991-1993; Founding Director, AG Bell Academy for Listening and Spoken Language, 2006 -
Publications: twenty-four works in American Journal of Audiology, Seminars in Hearing, Volta Review, Australian Journal of Education of the Deaf, American Annals of the Deaf and contributed book chapters; presentations throughout U.S, Canada, Mexico, Europe, Australia, New Zealand, India, Saudi Arabia,UAE, Japan, Singapore,China.
Honors: Outstanding Young Women of America (5 issues); Who’s Who of Women Executives; Who’s Who in U.S. A. Health Specialists; Who’s Who in America; and Who’s Who Worldwide;Strathmore’s Who’s Who; International Sertoma “Service to Mankind” Award; Marion Downs Award; 2002 Saint Thomas More Medallion/ Commencement Speaker; 2003 Thomas More Professional Achievement Award; University of Cincinnati Communication Disorders Twenty-five Most Prominent Alumni,1989; University of Cincinnati Communication Disorders “2005 Distinguished Alumnus.”
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