The best regulatory affairs managers review guidance documents and quickly identify which elements are most important and will require the most amount of time. These elements are prioritized first for a regulatory submission project.

In last week’s blog (http://www.medicaldeviceacademy.com/blog/), I mentioned 4 unique elements that the FDA recommends for inclusion in a pre-sub meeting request for a De Novo application:

1. Proposed product classification (i.e., Class I, Class II exempt, or Class II)
2. Details of efforts previously taken in order to identify a predicate
3. Risks and Risk/Benefit Analysis
4. Proposed Performance Testing and/or Special Controls

What the FDA doesn’t tell you is how to prioritize your efforts. Most companies seem to focus on #1 and #2, but #3 needs to be first. Risk analysis is an input into the design of a device. For each risk identified there should be risk controls. If there is an existing recognized standard you can use as a risk control (e.g., ISO 10993-1 for biocompatiblity), then that standard is your risk control and the proposed performance testing plan should reference the standard and applicable tests. if you have risks there is no recognized standard for, then you need to try to identify another industry standard that is appropriate as a risk control.

In addition to the risks, you need to clearly identify the benefits of your product relative to other treatment options. You may need to demonstrate those benefits quantitatively by performing a clinical study or animal study. Testing should be compared with the best alternative treatment option. If you need help writing your risk/benefit analysis, the FDA provides a guidance document specifically for this:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf

The guidance was specifically titled “benefit-risk determinations” in order to emphasize that you need to demonstrate a clinical benefit for the risks of approving a De Novo application. When the FDA assesses the benefit-risk, they must estimate the extent of benefit by determining the following:

1. type of benefits
2. magnitude of benefits
3. probability of patients experiencing one or more benefit
4. duration of beneficial effects

In addition, the FDA must estimate the risks for device-related and procedure-related adverse events by determining the following information:

1. severity of injuries
2. type of injuries
3. number of injuries
4. frequency of events
5. probability of events resulting in injury
6. duration of harmful events
7. probability of false-positive and false-negatives for diagnostic products

In the guidance the FDA provides 4 detailed examples of benefit-risk determinations to help companies present a risk-benefit analysis in the pre-sub meeting request and the ultimate De Novo application.

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Tomorrow, January 28th, I’m sharing my own tips and templates for De Novo applications. Visit the following webpage in order to register for the live webinar:

http://medicaldeviceacademy.com/de-novo-application-webinar/.

source: https://www.linkedin.com/groups/2070960/2070960-6098100547120881664