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).

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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

510(k) Programs

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

Related information to review at your own pace:

• 510(k) Third-Party Review Program - Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations

Q-Submission Program

Standards and Conformity Assessment Program

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

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:

Other Training and Guidances

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.