Regulatory Open Forum

Hi All,

I am looking for some guidance on US FDA's Enforcement Discretion. I understood that, when FDA exercises Enforcement Discretion, then no pre-market submission is required for such product.

Any help on guidance is appreciated.

Thanks,

Sreenu

Hi Sreenu.

I generally agree with Mark - every fact situation is going to be different and FDA can look at specific facts involved to determine whether or not a particular situation meets the FDA internal requirements to exercise that discretion.

Simply put - think of it like this: when FDA exercises its enforcement discretion the agency is effectively saying, "We believe your product falls under our jurisdiction and what you are doing is a violation of the law and/or regulations, but we are OK with the overall benefit-risk analysis to allow you to continue doing this until we tell you differently."  So enforcement discretion is really a theoretically limited allowance to violate the requirements in FDA's eyes that can be revoked at any time without the agency necessarily giving significant warning before revocation because you have been put on notice that FDA believes that the activity violates the requirements.  Always a dangerous place to be and a place from which to remove yourself as quickly as reasonably possible in my opinion because you never know when FDA leadership might change their minds about the discretion they have afforded.

Enforcement Discretion is a topic with many interesting aspects. You ask specifically about pre-market submissions but enforcement discretion extends beyond this topic.

FDA is one of the largest law enforcement agencies in the US. In some cases, FDA asserts its legal authority over certain activities, but has chosen, as a matter of policy, not to enforce its authority. While I say “a matter of policy”, I don’t know of a written policy that enumerates all such cases.

It is also important to distinguish among some cases.

An FDA Investigator finds a minor violation during an Inspection. The Investigator may decide not to include this violation on a 483. This not an example of enforcement discretion, since there is no FDA policy to ignore this kind violation. It just wasn’t worth the 483 citation.

FDA asserts they have the authority to regulate suppliers of components to device manufacturers, but chooses not to. This is enforcement discretion.

FDA asserts the authority to regulate laboratories that develop and run tests internally as IVD manufacturers, but chooses not to. This is enforcement discretion.

FDA asserts that changes to shipped devices are subject to corrections and removals in part 806, but, in the postmarket cybersecurity guidance document, says they will not enforce reporting when the device manufacturer meets certain conditions. This is enforcement discretion

Hi All - Thanks for all your detailed information and examples. These are quite helpful to me. I was looking for a document (FDA guidance) to understand and did some search and found the below:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM285325.pdf

Under Section C - Enforcement Discretion, I have found some more information. 

Also found that recently, FDA has applied enforcement discretion for some mobile medical applications.

Thanks,

Sreenu