FDA Reporting for Safer Medical Products Only $24.95
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Accepted by Reptrax, VendorMate and Symplr (VCS) Credentialing Services
Faculty: Donna L Atherton RN, MSN, NP and Carol Pierini MA

Release Date: Jan 1, 2017
Valid Through: Jan 1, 2019. This course will be updated or expired on this date
Successful Completion: Complete entire module, complete the exam with a passing score of 80% or better, and complete the evaluation form
Estimated Time to Complete Activity: 60 minutes
CEUs: See Continuing Education section
Media: Internet. Available 24/7 365 Online. See requirements below

Overview

Broaden your knowledge of mandatory and voluntary medical device reporting as put forth by the Center for Devices and Radiological Health in the U.S. Food and Drug Administration.

learning objectives

  • Identify medical device reporting requirements of adverse events to the FDA and the manufacturer.
  • Describe the steps and requirements for reporting to the FDA 
  • Discover how the FDA enforces Medical Device Reporting

Content

Content

Commonly referred to as: Medical Device Reporting and FDA Reporting for Safer Medical Products

Mandatory Reporters include:

•Manufacturers of medical devices
•Importers of medical devices
•Medical Device user facilities

The FDA encourages voluntary reporting about adverse events (AEs) by the following:
•Health care professionals
•Patients
•Caregivers
•Consumers
 
Manufacturers are mandated to report to the FDA:
• When they learn that any of their devices may have caused or  contributed to a death or serious injury.
•When they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
 
Importers are mandated to report to the FDA and the Manufacturer:
•When they learn that any of their devices may have caused or contributed to a death or serious injury.
Importers are mandated to report to the Manufactuer:
•If their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Medical Device User Facilities
•Hospital, Ambulatory surgical facility, nursing home, outpatient diagnostic facility, outpatient treatment facility that is not a physician’s office.
Medical Device User Facilities are mandated to report to the FDA and the Manufacturer:
•A suspected medical device-related death,
Medical Device User Facilities are mandated to report to the Manufacturer:
•A medical device-related serious injury.
•If the manufacturer is not know, this must be reported to the FDA.

features

  • • Instant Certificate Of Completion Printing Upon Successful Completion Of Online FDA Reporting for Safer Medical Products Training Course
  • • Free Retakes on Exam Until You Pass
  • • Instant Access: 100% Online - Access 24/7 from Anywhere
  • • 30 Day Money Back Guarantee: No Recurring Fees

Continuing Education


Disclosures of Conflicts of Interest

HIPAA Exams, Inc. requires that the faculty participating in any activity disclose all affiliations or other financial relationships (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with any commercial supporters of the activity. All conflicts of interest have been resolved prior to this activity. HIPAA Exams, Inc. also requires participating faculty to disclose when unapproved/unlabeled uses of a product are discussed in a activity.

Disclosure of Unlabeled Use

This activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers’ prescribing information for these products.


Disclaimer

The content for this activity was developed independently of the commercial support. All materials are included with permission. The opinions expressed are those of the faculty and are not to be construed as those of the publisher or grantor.

This educational activity was planned and produced in accordance with the ANCC Accreditation Criteria, Policies, and Standards for Commercial Support. Recommendations involving clinical medicine in a continuing medical education activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis.


Operating Systems Requirements

  • Windows: XP or higher
  • Mac OS X: 10.5 or higher
  • Android:* Lollipop and Marshmallow
  • iOS:* 9 or higher

Minimum System Requirement

  • Disk Space: 600 MB of free hard drive space

Browsers

  • Windows: Internet Explorer 8 or higher**, Firefox latest (32-bit), Chrome latest
  • Mac OS X: Safari 7 and above
  • Pop-up blockers should be turned off

Internet Connection Speed

  • Windows: Intel Pentium® processor (1GHz or faster), At least 1 GB RAM

Display

  • Graphics card: 800x600 pixel resolution or greater (1024x768 pixels recommended).

Only $24.95


GROUP PRICING

Bundle Price Per Person
1-14 $24.95
15-49 $19.99
50-99 $17.99
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