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Tuesday, October 15, 2019
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Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme (MDU3)

Certification Training
Rated 3.77/5
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Duration: 1.7 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $169.00

BioPharma Institute LogoTraining Program: Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute Reviews

This course introduces the student to the required activities necessary before a device is ready to go to market in the United States. The US Regulatory Affairs Overview (MDU1) course is recommended as an introduction before taking this course. Course objectives consist of the following: To provide a description of the 510(k) submission process, to list the elements which are essential parts of a 510(k) submission, to introduce some examples of when items are required and when additional items are required, to introduce the 3 types of 510(k) submissions and provide examples of when they are required, to determine when a 510(k) is not required vs. when it is, and offer a description of the purpose of the Premarket Notification 510(k) Program.

Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. With expertise in the management of large training projects, the BioPharma Institute strives to assist professionals in furthering their understanding of the healthcare, pharmaceutical, and biotechnology industries, to help them uncover new discoveries within those fields, and assist in understanding the peripheral technologies contained within those industries.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme course is found in the following professional certification program(s):

US Medical Device Regulatory Affairs Professional Certification Program: This online certification program provides an introduction to the Code of Federal Regulations (CFRs). It introduces students to the activities that are essential prior to a device being set to go to the United ... Learn more



1. Welcome
2. Introduction
3. Reviews and assessments

4. Introduction
5. Medical device exemptions
6. Substantial equivalence
7. Regulatory requirements
8. Who needs to submit a 510(k)
9. When to submit a 510(k)
10. When a 510(k) is not required
11. Preamendment devices
12. Topic review

TYPES OF 510(k)
13. Introduction
14. The new 510(k) paradigm
15. Content of the 510(k)
16. Content of the Traditional 510(k)
17. Content of the Special 510(k)
18. Abbreviated 510(k)
19. Content of the Abbreviated 510(k)
20. Topic review

21. Introduction
22. Sterilization and shelf life
23. Biocompatibility
24. Software
25. Electromagnetic compatibility
26. Performance testing
27. Topic review

28. Introduction
29. 510(k) cover letter
30. Cover letter design factors
31. 510(k) Summary or Statement
32. Truthful and Accurate Statement
33. Topic review

34. Introduction
35. Acceptance and review
36. Requests for additional information
37. Decision letter

38. Summary I
39. Summary II


Describe the purpose of the Premarket Notification 510(k) Program.

Determine when a 510(k) submission is required and when it is not required.

List the three types of 510(k) submissions and give examples of when each is required.

List the essential elements of a 510(k) submission.

List the additional requirements and give examples of when they are required.

Describe the 510(k) submission process.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email

Information Request / Suggest a Course Form: