Regulatory Open Forum

​Not a follower of 510(k) stuff, so maybe I missed something related to this CDRH request for comments:

https://www.regulations.gov/document?D=FDA-2018-N-4751-0001

The attachment is a single page which states that "FDA is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices."  I assume this is somehow related to the proposal not to accept predicates more than 10 years old.

Since I was under the impression that these devices are already public on FDA's website, upon reading this proposal, I experienced momentary panic.  After all, CDRH summarily deleted decades' worth of NSEs from its 510(k) database, so who knows, maybe it had up and deleted all the predicates more than 10 years old as well.  But no, they are all still there.  Whew!

Reassured, I went back to the request for comments and found that FDA is proposing to post a LIST of such devices and is requesting feedback on four questions:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?  So I have problems with "should," a word I think should never be used in isolation from an objective. Is it written on a stone tablet somewhere that CDRH shalt post...?  Don't think so.  Otherwise, it seems to me that there is nowhere to go with is without knowing 1) what purpose CDRH imagines this list would serve and 2) why CDRH thinks a list would better serve this purpose than the existing database.

• Should the FDA consider using other criteria to inform our point of reference? Point of reference for what?

• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices? CDRH already issued its medical device safety action plan. Isn't it a little late to be asking this type of open-ended question?

• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?  Certainly that would be better than considering uncertain actions; otherwise, I don't see how anyone can comment usefully on the "should's" associated with unnamed actions.  If they just want to know if we think they should exclude all devices over 10 years old from serving as predicates, can't they just ask that flat out?

Can anyone here shed some light?

​Not a follower of 510(k) stuff, so maybe I missed something related to this CDRH request for comments:

https://www.regulations.gov/document?D=FDA-2018-N-4751-0001

The attachment is a single page which states that "FDA is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices."  I assume this is somehow related to the proposal not to accept predicates more than 10 years old.

Since I was under the impression that these devices are already public on FDA's website, upon reading this proposal, I experienced momentary panic.  After all, CDRH summarily deleted decades' worth of NSEs from its 510(k) database, so who knows, maybe it had up and deleted all the predicates more than 10 years old as well.  But no, they are all still there.  Whew!

Reassured, I went back to the request for comments and found that FDA is proposing to post a LIST of such devices and is requesting feedback on four questions:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?  So I have problems with "should," a word I think should never be used in isolation from an objective. Is it written on a stone tablet somewhere that CDRH shalt post...?  Don't think so.  Otherwise, it seems to me that there is nowhere to go with is without knowing 1) what purpose CDRH imagines this list would serve and 2) why CDRH thinks a list would better serve this purpose than the existing database.

• Should the FDA consider using other criteria to inform our point of reference? Point of reference for what?

• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices? CDRH already issued its medical device safety action plan. Isn't it a little late to be asking this type of open-ended question?

• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?  Certainly that would be better than considering uncertain actions; otherwise, I don't see how anyone can comment usefully on the "should's" associated with unnamed actions.  If they just want to know if we think they should exclude all devices over 10 years old from serving as predicates, can't they just ask that flat out?

Can anyone here shed some light?

​Not a follower of 510(k) stuff, so maybe I missed something related to this CDRH request for comments:

https://www.regulations.gov/document?D=FDA-2018-N-4751-0001

The attachment is a single page which states that "FDA is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices."  I assume this is somehow related to the proposal not to accept predicates more than 10 years old.

Since I was under the impression that these devices are already public on FDA's website, upon reading this proposal, I experienced momentary panic.  After all, CDRH summarily deleted decades' worth of NSEs from its 510(k) database, so who knows, maybe it had up and deleted all the predicates more than 10 years old as well.  But no, they are all still there.  Whew!

Reassured, I went back to the request for comments and found that FDA is proposing to post a LIST of such devices and is requesting feedback on four questions:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?  So I have problems with "should," a word I think should never be used in isolation from an objective. Is it written on a stone tablet somewhere that CDRH shalt post...?  Don't think so.  Otherwise, it seems to me that there is nowhere to go with is without knowing 1) what purpose CDRH imagines this list would serve and 2) why CDRH thinks a list would better serve this purpose than the existing database.

• Should the FDA consider using other criteria to inform our point of reference? Point of reference for what?

• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices? CDRH already issued its medical device safety action plan. Isn't it a little late to be asking this type of open-ended question?

• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?  Certainly that would be better than considering uncertain actions; otherwise, I don't see how anyone can comment usefully on the "should's" associated with unnamed actions.  If they just want to know if we think they should exclude all devices over 10 years old from serving as predicates, can't they just ask that flat out?

Can anyone here shed some light?

​Not a follower of 510(k) stuff, so maybe I missed something related to this CDRH request for comments:

https://www.regulations.gov/document?D=FDA-2018-N-4751-0001

The attachment is a single page which states that "FDA is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices."  I assume this is somehow related to the proposal not to accept predicates more than 10 years old.

Since I was under the impression that these devices are already public on FDA's website, upon reading this proposal, I experienced momentary panic.  After all, CDRH summarily deleted decades' worth of NSEs from its 510(k) database, so who knows, maybe it had up and deleted all the predicates more than 10 years old as well.  But no, they are all still there.  Whew!

Reassured, I went back to the request for comments and found that FDA is proposing to post a LIST of such devices and is requesting feedback on four questions:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?  So I have problems with "should," a word I think should never be used in isolation from an objective. Is it written on a stone tablet somewhere that CDRH shalt post...?  Don't think so.  Otherwise, it seems to me that there is nowhere to go with is without knowing 1) what purpose CDRH imagines this list would serve and 2) why CDRH thinks a list would better serve this purpose than the existing database.

• Should the FDA consider using other criteria to inform our point of reference? Point of reference for what?

• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices? CDRH already issued its medical device safety action plan. Isn't it a little late to be asking this type of open-ended question?

• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?  Certainly that would be better than considering uncertain actions; otherwise, I don't see how anyone can comment usefully on the "should's" associated with unnamed actions.  If they just want to know if we think they should exclude all devices over 10 years old from serving as predicates, can't they just ask that flat out?

Can anyone here shed some light?

​Not a follower of 510(k) stuff, so maybe I missed something related to this CDRH request for comments:

https://www.regulations.gov/document?D=FDA-2018-N-4751-0001

The attachment is a single page which states that "FDA is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices."  I assume this is somehow related to the proposal not to accept predicates more than 10 years old.

Since I was under the impression that these devices are already public on FDA's website, upon reading this proposal, I experienced momentary panic.  After all, CDRH summarily deleted decades' worth of NSEs from its 510(k) database, so who knows, maybe it had up and deleted all the predicates more than 10 years old as well.  But no, they are all still there.  Whew!

Reassured, I went back to the request for comments and found that FDA is proposing to post a LIST of such devices and is requesting feedback on four questions:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?  So I have problems with "should," a word I think should never be used in isolation from an objective. Is it written on a stone tablet somewhere that CDRH shalt post...?  Don't think so.  Otherwise, it seems to me that there is nowhere to go with is without knowing 1) what purpose CDRH imagines this list would serve and 2) why CDRH thinks a list would better serve this purpose than the existing database.

• Should the FDA consider using other criteria to inform our point of reference? Point of reference for what?

• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices? CDRH already issued its medical device safety action plan. Isn't it a little late to be asking this type of open-ended question?

• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?  Certainly that would be better than considering uncertain actions; otherwise, I don't see how anyone can comment usefully on the "should's" associated with unnamed actions.  If they just want to know if we think they should exclude all devices over 10 years old from serving as predicates, can't they just ask that flat out?

Can anyone here shed some light?

​Not a follower of 510(k) stuff, so maybe I missed something related to this CDRH request for comments:

https://www.regulations.gov/document?D=FDA-2018-N-4751-0001

The attachment is a single page which states that "FDA is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices."  I assume this is somehow related to the proposal not to accept predicates more than 10 years old.

Since I was under the impression that these devices are already public on FDA's website, upon reading this proposal, I experienced momentary panic.  After all, CDRH summarily deleted decades' worth of NSEs from its 510(k) database, so who knows, maybe it had up and deleted all the predicates more than 10 years old as well.  But no, they are all still there.  Whew!

Reassured, I went back to the request for comments and found that FDA is proposing to post a LIST of such devices and is requesting feedback on four questions:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?  So I have problems with "should," a word I think should never be used in isolation from an objective. Is it written on a stone tablet somewhere that CDRH shalt post...?  Don't think so.  Otherwise, it seems to me that there is nowhere to go with is without knowing 1) what purpose CDRH imagines this list would serve and 2) why CDRH thinks a list would better serve this purpose than the existing database.

• Should the FDA consider using other criteria to inform our point of reference? Point of reference for what?

• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices? CDRH already issued its medical device safety action plan. Isn't it a little late to be asking this type of open-ended question?

• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?  Certainly that would be better than considering uncertain actions; otherwise, I don't see how anyone can comment usefully on the "should's" associated with unnamed actions.  If they just want to know if we think they should exclude all devices over 10 years old from serving as predicates, can't they just ask that flat out?

Can anyone here shed some light?