FDA Shelf Life Requirements for EO Surgical gown 510k

[regfocus]

We have a 510k under FDA's review. The reviewer kick back the following questions about Shelf life.

FDA Questions:

Shelf Life

You claim that the subject device in sterile packaging has a shelf life of three years, based on testing under accelerated conditions. You did not provide shelf-life testing on real-time aged samples. You did not clearly state if the real time aging is ongoing to confirm the proposed shelf life of the subject device. Also, you did not submit a protocol with the conditions of real time aging and your planned testing at different time points, with acceptance criteria.

To answer FDA's questions,
1) Do we really need to submit a real time aging testing for 3 years?
2) Can we just provide FDA a protocol (claim 3 year shelf life) with a protocol with the conditions of real time aging and our planned testing at different time points, with acceptance criteria, in stead of doing and submitting 3 years real-time aging test now?
3) If we can just submit 3 years real-time aging protocol to FDA, can we get 510k approval letter with 3 years on?
4) Assume we get the 3 years shelf life FDA approval letter, then do we need to submit a 3 years shelf life tests data and report (after 3 years in our testing chamber) to FDA as supplemental files?

You also state that, the subject device is made of polypropylene; therefore, its physical and mechanical properties may not change over shelf life of three years. This is not acceptable. Please provide data to show that physical and mechanical properties of the subject device are maintained in its primary package over the claimed shelf life. Alternatively, please provide scientific justification why you believe additional testing is not needed.

This FDA question is related to the previous FDA's questions. To answer FDA's questions,
1) FDA requested the data to show that physical and mechanical properties of the subject device are maintained in its primary package over the claimed 3 years shelf life. Does that mean we have to wait 3 years to wait this data before we get FDA's 510k approval? In other words, FDA will reject our 510k application because the data we can provide is 3 years in the future.
2) How can we find the scientific justification to support the physical and mechanical properties of subject device made of polypropylene may not change over shelf life of three years?

 

[MIREGMGR]

Re: FDA Shelf life questions for EO Surgical gown 510k

1) Do we really need to submit a real time aging testing for 3 years?
2) Can we just provide FDA a protocol (claim 3 year shelf life) with a protocol with the conditions of real time aging and our planned testing at different time points, with acceptance criteria, in stead of doing and submitting 3 years real-time aging test now?

Yes, but usually FDA will accept a statement that such testing is under way as long as the testing is documented.

3) If we can just submit 3 years real-time aging protocol to FDA, can we get 510k approval letter with 3 years on?

Yes, usually.

4) Assume we get the 3 years shelf life FDA approval letter, then do we need to submit a 3 years shelf life tests data and report (after 3 years in our testing chamber) to FDA as supplemental files?

No. The RTA data goes into your design files.

1) FDA requested the data to show that physical and mechanical properties of the subject device are maintained in its primary package over the claimed 3 years shelf life. Does that mean we have to wait 3 years to wait this data before we get FDA's 510k approval? In other words, FDA will reject our 510k application because the data we can provide is 3 years in the future.
2) How can we find the scientific justification to support the physical and mechanical properties of subject device made of polypropylene may not change over shelf life of three years?

You made a formal statement to them that the mechanical and physical properties would not change. What evidence was that statement based on? You never want to make a statement to FDA without evidence, because they may call you on it.

If you don't have scientific evidence from someone else's study, for instance by the maker of the material, you'll have to do your own study. You say you already have 3 year AA completed. Did you do before-and-after testing of the relevant parameters for units from that accelerated aging? If so, you'll want to be sure that the same testing is included in your real time aging protocol.

 

[regfocus]

Re: FDA Shelf life questions for EO Surgical gown 510k

Questions:

1) What are the specific properties mean in"physical and mechanical properties of the subject device (surgical gown)"?

2) Do I need to test the properties twice before and after the accelerated shelf life test?

3) Because the shelf life test always degrade the physical and mechanical properties of the subject device, can I just test the properties one time after the accelerated shelf life test instead of before-and-after twice tests? My thought is if the physical and mechanical properties of degraded subject device can meet criteria, why we test before-and-after twice?

Yes, but usually FDA will accept a statement that such testing is under way as long as the testing is documented.

Yes, usually.
No. The RTA data goes into your design files.

You made a formal statement to them that the mechanical and physical properties would not change. What evidence was that statement based on? You never want to make a statement to FDA without evidence, because they may call you on it.

If you don't have scientific evidence from someone else's study, for instance by the maker of the material, you'll have to do your own study. You say you already have 3 year AA completed. Did you do before-and-after testing of the relevant parameters for units from that accelerated aging? If so, you'll want to be sure that the same testing is included in your real time aging protocol.

 

[MIREGMGR]

Re: FDA Shelf life questions for EO Surgical gown 510k

1) What are the specific properties mean in"physical and mechanical properties of the subject device (surgical gown)"?

You have the specific FDA guidance for surgical gowns, right? Section II.D. lists standards for which you must show conformance. Most of those standards will require you to establish material properties or device performance. And, Section II.E. lists specific mechanical and physical parameters that you must compare to your predicate.

Note that the standards list pre-dates AAMI/ANSI PB70. You very likely will be expected to declare a PB70 conformance level, and provide data to support that declaration.

2) Do I need to test the properties twice before and after the accelerated shelf life test?
3) Because the shelf life test always degrade the physical and mechanical properties of the subject device, can I just test the properties one time after the accelerated shelf life test instead of before-and-after twice tests? My thought is if the physical and mechanical properties of degraded subject device can meet criteria, why we test before-and-after twice?

With all due respect, you quoted the FDA examiner above as saying that you told FDA in your initial filing that properties would not change over three years, and now you're saying that aging always causes properties to change? Were you fibbing then, or are you wrong now? If FDA decides you've told an untruth to them, you have a Big Problem.

Yes, you have to test before and after aging. The point is to support your statement that properties won't change over three years.

It'd be nice if I didn't have to mention this, but: note that if FDA thinks you've submitted intentionally fudged data, Really Bad Things could happen.

 

[regfocus]

Re: FDA Shelf life questions for EO Surgical gown 510k

You have the specific FDA guidance for surgical gowns, right? Section II.D. lists standards for which you must show conformance. Most of those standards will require you to establish material properties or device performance. And, Section II.E. lists specific mechanical and physical parameters that you must compare to your predicate.

Note that the standards list pre-dates AAMI/ANSI PB70. You very likely will be expected to declare a PB70 conformance level, and provide data to support that declaration.

With all due respect, you quoted the FDA examiner above as saying that you told FDA in your initial filing that properties would not change over three years, and now you're saying that aging always causes properties to change? Were you fibbing then, or are you wrong now? If FDA decides you've told an untruth to them, you have a Big Problem.

Yes, you have to test before and after aging. The point is to support your statement that properties won't change over three years.

It'd be nice if I didn't have to mention this, but: note that if FDA thinks you've submitted intentionally fudged data, Really Bad Things could happen.

My questions: Our mechanical and physical parameters were tested after accelerated aging and sent to FDA in our initial submission. And we used data after accelerated aging to compare our predicate. In our initial submission, we just mentioned we think these mechanical and physical parameters are not changed during 3 years shelf life due to the material is polypropylene which is stable materials (Maybe this was a bad superfluous)

Put this specific case away, general speaking, the properties test are required for both before and after aged samples (no matter accelerated/real-time aging) for any sterilized medical device?

 

[MIREGMGR]

Re: FDA Shelf life questions for EO Surgical gown 510k

general speaking, the properties test are required for both before and after aged samples (no matter accelerated/real-time aging) for any sterilized medical device?

Yes, that's correct.

 

[blargon]

Great feedback from MIREGMGR.
Have you real-time aging data for your predicate device?

 

[regfocus]

Re: FDA Shelf life questions for EO Surgical gown 510k

Yes, that's correct.

FDA requested to provide real-time aging protocol to determine the 3 years shelf life claim for surgical gown.

1) I found there is a FDA guidance - Recommended Protocol for Real-Time Aging of Medical Gloves
to Determine Shelf Life on page 7

http://www.fda.gov/OHRMS/DOCKETS/98fr/994487gd.pdf

But it is for Medical Gloves, how can I draft a protocol for surgical gown? Just change the name of medical gloves to surgical gown? That's it?

2) Is there any FDA Guidance or FDA recognized standards addressed how to plan a protocol?



3)

 

[MIREGMGR]

Re: FDA Shelf life questions for EO Surgical gown 510k

http://www.fda.gov/OHRMS/DOCKETS/98fr/994487gd.pdf

But it is for Medical Gloves, how can I draft a protocol for surgical gown? Just change the name of medical gloves to surgical gown?

No. The Guidance is just that...a guidance. You aren't trying to write a guidance. Your protocol will want to be written to follow the guidance, in general, taking into account that your product is different. You'll be writing rules for what you'll do test-wise, so your language will be mostly Shalls instead of Shoulds.

 

[regfocus]

Re: FDA Shelf life questions for EO Surgical gown 510k

No. The Guidance is just that...a guidance. You aren't trying to write a guidance. Your protocol will want to be written to follow the guidance, in general, taking into account that your product is different. You'll be writing rules for what you'll do test-wise, so your language will be mostly Shalls instead of Shoulds.

FDA guidance - Recommended Protocol for Real-Time Aging of Medical Gloves to Determine Shelf Life on page 7

http://www.fda.gov/OHRMS/DOCKETS/98fr/994487gd.pdf

It says --
5.3 ?Baseline? gloves should meet the ?Before Accelerated Aging? requirements for tensile strength and percent elongation as set forth in the appropriate standard. All gloves aged 6 months and greater should meet the ?After Accelerated Aging? requirements for tensile strength and percent elongation as set forth in the appropriate standard.

My question:
1) What does the "Baseline" here mean?
2) This is a real time aging study, why should meet the ?Before Accelerated Aging? requirements and ?After Accelerated Aging? requirements?