510(k) Pre-Submission Contents
FDA recommends that the Pre-Sub should contain sufficient information for FDA to provide advice to your specific questions. In addition to the information suggested in Section III.A.5 of this guidance (downloadable at the bottom of this page), “Recommended Information for Pre-Sub Packages,” it is suggested that we also provide the following, where applicable.
Proposed Predicate Devices
The 510(k) review process focuses on the comparison of a proposed device with a predicate device in terms of intended use, technological characteristics, and, as appropriate, performance testing. As a result, you should provide a summary of the predicate device(s) you plan to use for your comparison of these characteristics, along with the intended use, indication(s) for use and technological characteristics of the device you would like to market. For each predicate device you identify, we suggest you provide:
- the predicate device trade name, including model, if available;
- the 510(k) number under which the predicate device was cleared;
- the classification of the predicate device;35 and
- a comparison with the proposed device in terms of indications for use, technological characteristics, and performance testing.
Please note that FDA will not make a final determination about the suitability of a proposed predicate device until the submission and review of your 510(k).
A summary of performance testing may include the following:
- bench testing (such as biocompatibility, mechanical, electrical safety, electromagnetic compatibility (EMC), wireless compatibility, magnetic resonance (MR) compatibility, or software, and comparison to the predicate device);
- animal studies (in vivo and histopathology); and
- clinical studies.
Please clearly distinguish any testing that has already been conducted from testing you plan to conduct in the future.
Information you may consider for inclusion with respect to performance may include a concise summary of the test plan that includes:
- identification of the objective or purpose of the test;
- explanation of the sample size and statistical methods, as applicable;
- summary of the test methodology (if you are following a recognized standard, include the name of the standard and year of publication)
- explanation of study endpoints; and
- explanation of study acceptance criteria.
As a reminder, test results and data do not need to be submitted in the Pre-Sub, as FDA will not make a final determination regarding substantial equivalence on the basis of the Pre-Sub. FDA will only make this comprehensive evaluation during its review of the 510(k) submission.
Examples of questions that may be appropriate to consider in a 510(k) Pre-Sub are given below.
- In addition to the biocompatibility testing recommended for the type and duration of tissue contact defined by FDA’s G95-1 Bluebook Guidance and ISO 10993-1, what other device-specific biocompatibility testing may be necessary to adequately evaluate the biocompatibility of my device?
- Is our justification for not conducting carcinogenicity studies adequate?
Bench and Animal Testing
- Does FDA concur it is appropriate to test only the smallest and largest sizes of my device in comparison to a predicate device when I plan to market at least ten (10) different sizes that differ in dimensions?
- Does FDA concur with our worst-case rationale for this device?
- Does the FDA concur with the use of the proposed alternative test method, which is different than the normally recognized standard?
- Is the animal model I propose appropriate for testing my device?
- Is a “moderate level of concern” the appropriate level of concern for my software?
Human Factors Evaluation
- Is my planned approach to human factors assessment appropriate for the intended use of my device?36
- Is it advisable to conduct a clinical evaluation of my device or is the battery of bench and animal testing I propose likely to be adequate? (In some cases, FDA may not be able to assess whether bench and animal data are sufficient in lieu of clinical data until the agency has been able to complete a review of the nonclinical testing.)
- If clinical data are needed for my device, are the proposed trial design and selected control group appropriate or is the protocol from a previously conducted study appropriate?
- Are there concerns with the predicate device proposed?
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