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Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme (MDU3)

Certification Training
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Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the Biopharma Institute for more information.

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

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

Schedule: Self-paced. Immediate access to training materials 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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.

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



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.

The Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme Course is Included in the Following Professional Certification Programs:

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

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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