Training Curriculum for Third-Party Reviewers
The FDA's Center for Devices and Radiological Health (CDRH) developed this curriculum to help educate third-party reviewers on the regulatory framework, regulatory requirements, and review processes of a 510(k) premarket notification. The core curriculum consists of courses for third-party reviewers (3P510K Review Organizations) to help achieve FDA-equivalent reviews.
Intended audience: The FDA strongly encourages all third-party reviewers to participate in this training curriculum. The FDA may request documentation during audits about participation in the training curriculum. Therefore, we encourage the 3P510k Review Organization taking the training to keep track of who participated.
Goal: This curriculum meets the 510(k) Third Party Review Program goals by providing similar content and training tools that the FDA reviewers receive. Therefore, the FDA expects that third-party reviewers complete this curriculum with the goal of increasing the quality of 3P510k submissions.
Device-specific training: This curriculum includes device-specific training for 3P510k Review Organizations that are accredited in related product codes. For example, if a 3P510k Review Organization reviews dental devices, they should take the dental device training.
Length: The total training hours for the curriculum is roughly 24 hours (or three business days).
Orientation Teleconference with the FDA
The FDA expects 3P510k Review Organizations to join the FDA for a 20-minute teleconference to introduce the training curriculum and provide details on the courses. The orientation serves as a road map for the third-party reviewer and will assist them in navigating the curriculum.
Introduction to Medical Devices and CDRH
| Order | Course Name | Course Links | Duration |
|---|---|---|---|
| 1 | An Introduction to FDA's Regulation of Medical Devices Get a high-level overview of regulatory requirements, including 510(k), PMA, IDE and so forth. |
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22:53 |
| 2 | How Is CDRH Structured? Learn about the Center as well the office or review division with whom you will interact with on regulatory issues. |
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15:59 |
| 3 | Is My Product a Medical Device? Learn the definition of a medical device and about the FDA's Product Classification database. |
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23:59 |
| 4 | How Is My Medical Device Classified? Evaluate the risk of a device to determine its class and applicable regulatory controls. |
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16:18 |
| 5 | Case Study: How Is My Medical Device Classified? Learn how to conduct multiple searches in FDA's public databases utilizing three classification determination methods. |
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17:42 |
510(k) Programs
| Order | Course Name | Course Links | Duration |
|---|---|---|---|
| 1 | The 510(k) Program Get an introduction to the 510(k) Program, including both third-party and non-third-party submissions. |
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32:05 |
| 2 | The Special 510(k) Program: Final Guidance Learn about the Special 510(k) Program guidance and the Abbreviated 510(k) Program guidance. |
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1:09:33 |
| 3 | Quality in 510(k) Review Program Pilot Learn how the pilot program and the FDA's free eSubmitter software can lead to more efficient reviews. |
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46:44 |
Related information to review at your own pace:
- Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and Food and Drug Administration Staff
- Content of a 510(k)
- 510(k) Format Tips
510(k) Third-Party Review Program
| Order | Course Name | Course Links | Duration |
|---|---|---|---|
| 1 | 510(k) Third-Party Review Program Overview Get an overview of the Third Party 510(k) Review Program and the role of a third-party reviewer. |
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3:37 |
| 2 | Webinar – 510(k) Third Party Review Program: Final Guidance Get an overview of the program, identify eligible devices, recognize elements of an FDA-equivalent review, and more. |
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26:46 |
Related information to review at your own pace:
Q-Submission Program
| Order | Course Name | Course Links | Duration |
|---|---|---|---|
| 1 | Q-Submission Program for Medical Devices Submissions Learn how the program enables submitters to have early collaboration and discussions with the FDA about device submissions. |
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47:50 |
| 2 | The Pre-Submission Program and Meetings with FDA Staff Learn more about the program, including recommended information to submit in such requests. |
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27:48 |
Standards and Conformity Assessment Program
| Order | Course Name | Course Links | Duration |
|---|---|---|---|
| 1 | Standards Overview Get an overview of the Standards Program and how it is used in premarket submissions. |
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22:26 |
| 2 | Standards Resources and Premarket Use Learn how to find FDA recognized consensus standards in the Recognized Standards Database. |
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16:38 |
| 3 | CDRH Standards Recognition Process Learn how CDRH assesses and recognizes standards, how to request the recognition of a standard, and more. |
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9:26 |
| 4 | Appropriate Use of Voluntary Consensus Standards Learn about the least burdensome approach, consistency about data requests and test reports, and more. |
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1:20:34 |
Related information to review at your own pace:
- eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff. Note Section VI. f., "What if this is a Third Party 510(k)?" and third-party references throughout.
- eCopy Program for Medical Device Submissions: An online resource to help you understand the eCopy program and how to successfully create and submit a valid eCopy.
IT and Software
| Order | Course or Webinar Name | Course Links | Duration |
|---|---|---|---|
| 1 | Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Learn about information to include in premarket submissions for effective cybersecurity management. |
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1:22:12 |
| 2 | Postmarket Management of Cybersecurity in Medical Devices Receive a general overview of what information is expected in 510(k) submissions regarding cybersecurity. |
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1:26:06 |
Related information to review at your own pace:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
Device-Specific Training
The FDA expects third-party reviewers, preparing submissions for product codes in specific device areas, to take the following courses:
| Course or Webinar Name | Course Links | Duration |
|---|---|---|
| Dental Devices Premarket Submissions Learn about the premarket submission process for dental devices, including what to submit and who to work with in CDRH. |
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1:17:43 |
| X-Ray Systems: Third Party Review Learn the basic process for how to review an X-ray system to determine substantial equivalence. |
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34:10 |
| Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance Learn the regulatory history of diagnostic ultrasounds devices, recent technological advances, and new regulatory evaluation. |
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34:26 |
Related information to review at your own pace:
Other Training and Guidances
| Course or Webinar Name | Course Links | Duration |
|---|---|---|
| The Least Burdensome Provisions: Concept and Principles Learn about the final guidance, which describes the least burdensome approach to medical device regulation. |
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54:43 |
| Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Get an overview of the 2016 final guidance as well as previous guidances on sterility. |
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52:42 |
| Biocompatibility: Final Guidance on "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices" Learn about recommendations in the final guidance for using the ISO 10993-1 standard in premarket submissions |
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1:26:37 |
| Applying Human Factors and Usability Engineering to Medical Devices Get an overview of human factors standards, guidance documents, and how these topics relate to premarket submissions. |
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1:27:08 |
Related information to review at your own pace:
- Least Burdensome: The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and Food and Drug Administration Staff
- Sterility: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff
- Biocompatibility: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff
- Human Factors: Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Electromagnetic Compatibility: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Wireless Technology: Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Helpful Links on FDA.gov
- 510(k) Third Party Review Program
- Guidances: Guidance Documents (Medical Devices and Radiation-Emitting Products)
- Training: CDRH Learn
- Databases:
- 510(k) Premarket Notification: Search this database by 510(k) number, applicant, device name or FDA product code.
- Product Classification: This database includes the three letter device product codes and device class that refers to the level of CDRH regulation for the given device.
- MAUDE - Manufacturer and User Facility Device Experience: Search this database for reports of adverse events involving medical devices.
- Medical Device Recalls: Search this database for medical device recalls.
- Medical Device Databases: A table of all public medical device databases.