510(k) Working Group Reviewer Survey
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1. In reviewing a 510(k) application, you may find the device substantially equivalent to a predicate device when the device under review has a new intended use and:

2. In reviewing a laser 510(k) application, the predicate device was cleared for skin resurfacing and the new device would like to add wrinkle removal in conjunction with skin resurfacing. The reviewer has determined that there are no differences in therapeutic effect; therefore this represents:

3. In determining the intended use of the device, you would look at:

4. You have a 510(k) under review that has the same indication for use as the predicate but involves a new technology. While most of the information provided in the 510(k) is consistent with the specified indication for use, you find a reference to an indication that suggests a new intended use. You further investigate this issue by performing a cursory review of the literature and the MDRs. You discover that this type of device is being used by the medical community primarily for this new use. You have safety concerns about how this technology can be used for this new use but not for the labeled use. The sponsor has clearly stated that the device has the same intended use as the predicate, and the labeling has no reference to this new intended use. What decision should FDA make?

5. When you have a different indication for use and are trying to assess whether this presents a new intended use, what information do you consider to determine if there is a new intended use that would result in an NSE decision?

6. When reviewing a 510(k) for a modification to a predicate device, you need to determine which path to take on the flowchart. For the examples below, assume that the indications for use are unchanged and you get to the section of the flowchart that states, “Does New Device Have Same Technological Characteristics?” Which of the following represent a change in the technological characteristics from the predicate device to the subject device? (Select all that apply.)

7. Once you have identified that the subject device has the same intended use and different technological characteristics that could affect the safety or effectiveness of the device, you have to determine if those technological characteristics raise any new types of questions of safety or effectiveness. Which of the examples below represent a new type of safety or effectiveness question(s)? (Select all that apply.)

8. Regarding the 510(k) “Substantial Equivalence” Decision-Making Process flowchart, how difficult is it for you to make the determination that the new technological characteristics raise new types of safety or effectiveness questions?

9. What percentage of the time did you find it moderately or highly difficult to obtain the studies (performance, animal, or clinical) that were necessary for you to make your SE/NSE decision?

10. Consider the following 510(k) scenario. A sponsor submits a 510(k) seeking clearance for “Device X.” It is the same device type and has the same indications and intended use as “Predicate A,” but there are differences in technological characteristics between proposed “Device X” and “Predicate A,” and these technological differences could affect safety or effectiveness. Ordinarily, the next steps in the 510(k) decision-making process would be to determine whether the technological differences raise new types of safety or effectiveness questions, and, if the answer is no, to evaluate performance data to assess the impact of the technological differences. However, in this 510(k), the sponsor has also identified a second predicate device, “Predicate B.” This predicate is a different device type but the technological characteristics are the same as the proposed device. If you were the reviewer of this 510(k), which predicate device(s) would you use when making your SE/NSE determination for “Device X”?

11. The Awesomo device was cleared with general indications and labeling that do not specify an age range for the intended patient population or whether the device is for use in a clinical setting or at home. Which of the following changes would require a new 510(k)?

12. Which of the following technological device modifications could result in a new 510(k)? (Select all that apply.)

13. Which submissions can be bundled? (Select all that apply.)

14. What is a “bundled device” (“system”)? (Select all that apply.)

15. What constitutes a bundled submission but is not a bundled device (“system”)? (Select all that apply.)

16. Which of the following devices is NOT eligible for the de novo process? (Assume there are not any unmentioned factors that make them ineligible for de novo.)

17. Which of the following are examples of special controls? (Select all that apply.)

18. A 510(k) submission typically is not eligible for third-party review if it:

19. According to FDA’s guidance on third-party review, which of the following statements is true?

20. Which of the following items do you believe you have the authority to use to support your premarket review? (Select all that apply.)

21. Provide us with your contact information to receive complimentary access to the OnDemand training "Surviving Medical Device Recalls" presented by the Center's Bioresearch Monitoring staff.