Join the Heart Rhythm Society and the U.S. Food and Drug Administration (FDA) for an overview of the agency’s role in regulating medical devices. During this webinar panelists will discuss regulatory pathways used to determine safety and effectiveness of medical devices, and strategic initiatives underway to quickly introduce new technology into the marketplace. The panelist will also provide information on collaborative opportunities for investigators, how recalls are determined, and more. 

At the conclusion of the webinar, participants will be able to:

• Describe what the FDA does to protect public health.
• Describe device classifications and FDA regulatory processes for new technology.
• Discuss collaborative opportunities for investigators to engage in new technology studies.
• Explain collaborative opportunities for investigators, the role of practicing clinicians in reporting device malfunctions, and how recalls are determined.

Electrophysiologists
Allied Professionals
Teaching Hospitals
Fellows

Moderators

David J. Slotwiner, MD, FHRS

New York Presbyterian Queens | Chief, Division of Cardiology

Panelists

CAPT. Brian Lewis, MD 
U.S. Food and Drug Administration | Arrhythmia Cardiology, Commissioned Corps of the U.S. Public Health Service

Sara Royce, PhD
U.S. Food and Drug Administration | Acting Assistant Director of the Implantable Electrophysiology Device Team in the Office of Cardiovascular Devices, Center for Devices and Radiological Health 

Amit J. Shanker, MD, FHRS 
St Lawrence Health System | Chair of Cardiovascular Medicine 

George Van Hare, MD 
U.S. Food and Drug Administration | Physician/Medical Officer, Implantable Electrophysiology Devices

Accreditation Statement
The Heart Rhythm Society is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians AMA Designation Statement
The Heart Rhythm Society designates this internet enduring activity for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

ABIM Maintenance of Certification (MOC) Statement 

Successful completion of this ACE activity, which includes participation in the evaluation component, enables the participant to earn up to 1.25 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of ACE credits claimed for the activity. It is the ACE activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

ABP Maintenance of Certification (MOC) Statement 

Successful completion of this ACE activity, which includes participation in the activity and individual assessment of and feedback to the learner, enables the learner to earn up to 1.25 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program. It is the ACE activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting ABP MOC credit.

Royal College of Physicians and Surgeons of Canada MOC Recognition Statement
Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “ACE in Support of MOC” program in Section 3 of the Royal College’s MOC Program.

Other Credit Available
A Credit Certificate (for physicians) or Certificate of Participation (for non-physicians) will be provided to individuals seeking credit from the following organizations which accept AMA PRA Category 1 Credit(s)™. Note that participants are advised to contact their certifying body for specific information regarding credit submissions:
·         American Academy of Family Physicians (AAFP) (for elective credit)
·         American Academy of Nurse Practitioners Certification Board (AANPCB)
·         American Academy of Physician Assistants (AAPA)
·         American Nurses Credentialing Center (ANCC)
·         American Osteopathic Association (AOA) (for Category 2 credit)
·         Committee on Accreditation of Continuing Medical Education (Canada)
·         European Board for Accreditation in Cardiology (EBAC)
·         European CME Credits (ECMEC)
·         German Chambers of Physicians
·         National Society of Genetic Counselors (for Category 2 credit)
·         Oman Medical Specialty Board
·         Qatar Council for Healthcare Practitioners
·         Royal College of Physicians and Surgeons of Canada (RCPSC)

ACE Disclosure Policy

The Heart Rhythm Society is committed to the provision of Accredited Continuing Education (formerly known as Continuing Medical Education (CME)) that is balanced, objective, and evidence based. HRS adheres to the Standards for Integrity and Independence in Accredited Continuing Education of the Accreditation Council for Continuing Medical Education (ACCME) which require that those individuals in a position to control the content of an educational activity (including, but not limited to, planners, faculty, authors, committee members, content reviewers, editors, and staff) disclose all financial relationships with an ACCME-defined ineligible company* within the 24 months prior to the disclosure.


Any individual who refuses to disclose financial relationships is disqualified from participating in HRS ACE-certified activities. Owners and employees of ACCME-defined ineligible companies may have no role in the planning or implementation of ACE activities without a special written exemption from the HRS Chief Learning Officer that will be granted only in specific circumstances that meet ACCME requirements.


Any individual who refuses to disclose financial relationships is disqualified from participating in HRS ACE-certified activities. Owners and employees of ACCME-defined ineligible companies may have no role in the planning or implementation of ACE activities without a special written exemption from the HRS Chief Learning Officer that will be granted only in specific circumstances that meet ACCME requirements.


ACCME Definition:

*An ineligible company is one whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

Examples of such organizations include:

Advertising, marketing, or communication firms whose clients are ineligible companies
Bio-medical startups that have begun a governmental regulatory approval process
Compounding pharmacies that manufacture proprietary compounds
Device manufacturers or distributors
Diagnostic labs that sell proprietary products
Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
Manufacturers of health-related wearable products
Pharmaceutical companies or distributors
Pharmacy benefit managers
Reagent manufacturers or sellers


All relevant financial relationships have been mitigated.


Faculty Disclosure(s):

D. Slotwiner: No relevant financial relationships with ineligible companies to disclose.

B. Lewis: No relevant financial relationships with ineligible companies to disclose.

S. Royce: No relevant financial relationships with ineligible companies to disclose.

A.J. Shanker: No relevant financial relationships with ineligible companies to disclose.

G. Van Hare: No relevant financial relationships with ineligible companies to disclose.

Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner):
G Bird: No relevant financial relationships with ineligible companies to disclose.
J. Glenn: No relevant financial relationships with ineligible companies to disclose.
S. Sailor: No relevant financial relationships with ineligible companies to disclose.

The Heart Rhythm Society is committed to the provision of Accredited Continuing Education (formerly known as Continuing Medical Education (CME)) that is balanced, objective, and evidence based. HRS adheres to the Standards for Integrity and Independence in Accredited Continuing Education of the Accreditation Council for Continuing Medical Education (ACCME) which require that those individuals in a position to control the content of an educational activity (including, but not limited to, planners, faculty, authors, committee members, content reviewers, editors, and staff) disclose all financial relationships with an ACCME-defined ineligible company within the 24 months prior to the disclosure.


The Heart Rhythm Society takes steps to assure its learners and the public that the content of certified activities is accurate and reliable. The following principles are applied to the process of validating CME content. The content is peer-reviewed to ensure the following:

Fair Balance - that content is balanced among various options available for treatment and not biased toward a particular product or manufacturer.

Patient Treatment Recommendations - that patient treatment recommendations contained in the content are evidence-based, are appropriate for the target audience, and that the patient treatment recommendations contribute to overall improvement in patient care.

Scientific Validity - those scientific studies cited in the activity conform to standards accepted by the scientific community.

Learning Objectives - that the educational content supports the learning objectives of the activity, and that the objectives stated for performance-in-practice are actionable and measurable.

Omissions - that no seminal studies, data, or best evidence are missing