Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Anon,

Following are some brief answers to your questions - the information you are seeking is a bit more in depth where you may want to seek some further expert advice concerning exactly what you are planning to do with this study.

1. Observational Study is typically associated with pharmaceutical/medicinal products to do exactly that - observe; in the medical device world these would often be associated with usability studies.  A Case Series is a sub-set of population with the same conditions, same treatments, same symptoms, also being evaluated.  Again, a Case Series is not a common nomenclature in the medical device field.  If a device is approved/cleared in the United States, any post-launch study is just that - a study which could be usability, marketing, preference, etc., as long as the medical device is being used for its intended use.
2. Real World Evidence (RWE) gathering is a term used in the medical device field where information is obtained proactively from patients and/or users of the medical device.  Again, if the device is cleared/approved, this can be gathered in many different ways through surveys, feedback, complaints (reactive), servicing (reactive), and other methods such as if the device is "connected" and the company has access to use information.
3. This is a broad question, there are many guidance on RWE on the FDA website.  Post-launch studies are not regulated by the FDA, so you will not find much regulatory requirements, the medical device must conform with all of the other regulations, i.e. 801, 807, 820, 830, etc.
4. No, if the device is cleared/approved for the United States, then it can be sold and used according to intended use.  If the study is examining or gathering information outside the intended use, then a separate clinical study with IRB may be needed.
5. The "safety monitoring" which is more a pharma term would be done through customer complaints and adverse event reporting for medical devices.  This would apply to any medical device which is sold and used in the United States.

There are different ways post-launch information can be obtained for a medical device, so might be beneficial speaking further with an expert about your specific needs, the device type, what type of post-launch study is being planned, what the clinical data is being used for, etc.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Oct-2023 20:18
From: Anonymous Member
Subject: US Class 2 Medical Device Post approval 510k- Observational Study

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I'm working on a US Class II Medical device. We're in the planning stages of conducting a study post 510k clearance (no clinical evidence required by the FDA), which we currently refer to as "Observational Studies". This study is crucial for us to develop a commercialization strategy, including identifying the target patient population, determining endpoints, and conducting a value analysis system. I would greatly appreciate any insights on the following questions:

 

1. Could you please explain the distinctions or differences between 'Observational Studies' and 'Case Series'?

2. Are "Observational Studies" considered a part of "Real World Evidence gathering," or are these two entirely separate concepts?

3. Which regulatory guidance documents can I refer to for information on how to conduct these studies and what regulatory requirements apply?

4. Do these types of studies typically require approval from an Institutional Review Board (IRB)?

5. Do we need a data safety monitoring board for this study?

I tried to find this information on the US FDA website, but I was unable to find it.

I would appreciate your input.

Thanks.