Regulatory Open Forum

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?

Let me clarify my question. I concur that there is an important distinction between a law and a regulation. I had laws in mind.

While President Obama issued an Executive Order that dealt with enforcement discretion of immigration law, many executive agencies, including FDA, exercise enforcement discretion "on their own".

Attorney General Sessions espoused the doctrine that enforcement discretion is illegal and unconstitutional.

My example is that FDA has the stated position that LDTs are in vitro diagnostic devices covered by FD&CA, but has decided not to enforce the law in these special cases.

Under the Sessions Doctrine, is FDA's use of enforcement discretion illegal and unconstitutional?

While I'm not a lawyer and not necessarily conversant in immigration policies, I have a concern that I think there is an issue worthy of our discussion.

My understanding of President Obama's DACA decision is that as long as certain people meet specified conditions, then the relevant executive agencies would direct their enforcement activities away from them. In this case, to use a colloquial term, there are "bigger fish to fry". In other words, this is a case of enforcement discretion.

Many people says that this decision violates the law, violates the constitution, etc. President Trump has decided to terminate the program.

My question is not about DACA, but about the use of enforcement discretion by an executive agency in general and by FDA in particular. FDA uses enforcement discretion in many cases.

A small example is the guidance document on post-market cybersecurity. FDA says that as long as a device manufacturer implements certain conditions, enumerated in the guidance document, FDA will not enforce the Corrections & Removals regulation.

A large example is laboratory developed tests, LDTs. These are in vitro diagnostics devices manufactured by certain companies. FDA has a policy to not enforce the device regulations for these manufacturers, i.e., enforcement discretion.

My question is simple (but the answers may not be). If the DACA argument, as stated by the Attorney General, concludes that executive agencies may not exercise enforcement discretion, does this mean that FDA must also stop?