FDA QSR Inconsistency? Design Validation

W

Watchwait

#1
Folks,

I've come across something that may be old news to many of you - but I've just noticed it and "it" is creating somewhat of a "discussion" in my organization...

21CFR, Part 820, para 820.30(g) defines Design Validation as follows: "Design Validation....Design validation shall ensure that devices conform to defined used needs and intended uses..."

The FDA Medical Device Quality Systems Manual:
A Small Entity Compliance Guide
First Edition, HHS Publication FDA 97-4179, December 1996, Chapter 3 defines Design Validation as follows: "Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s)."

Conspicuously absent from this 2nd definition is the word "defined". If I may go on just a bit...

Using the 1st definition, an organization is responsible for defining and interpreting "user needs". Following this, we develop products which we hope will meet these user needs - again as defined and interpreted by the organization. Once developed, the design validation consists of assuring that the product meets the user needs as defined by the organization. IMHO, this approach does not assure that user needs were truly met. It only confirms that we designed and built what we think the customer wanted. Consequently the argument being posed here is that this definition (of design validation) does not require that the product be taken "to the field" in either a real-world, or simulated environment to confirm that user needs were truly met. It only requires that we confirm we designed and built what we thought the customer needed.

The 2nd definition, lacking the term "defined" would seem to obligate the organization to truly confirm that user needs were met - not just what the organization (Marketing, Engineering, etc) thought the customer required. Consequently, this definition of design validation would seem to obligate the manufacturer to perform a real world, or simulated environment confirmation.

Again, a subtle but potentially significant difference & one which I am posing to the "best & brightest" here at the Cove! Thank you for your patience!
 
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Jim Wynne

Staff member
Admin
#2
Re: FDA QSR Inconsistency?

Folks,

I've come across something that may be old news to many of you - but I've just noticed it and "it" is creating somewhat of a "discussion" in my organization...

21CFR, Part 820, para 820.30(g) defines Design Validation as follows: "Design Validation....Design validation shall ensure that devices conform to defined used needs and intended uses..."

The FDA Medical Device Quality Systems Manual:
A Small Entity Compliance Guide
First Edition, HHS Publication FDA 97-4179, December 1996, Chapter 3 defines Design Validation as follows: "Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s)."

Conspicuously absent from this 2nd definition is the word "defined". If I may go on just a bit...

Using the 1st definition, an organization is responsible for defining and interpreting "user needs". Following this, we develop products which we hope will meet these user needs - again as defined and interpreted by the organization. Once developed, the design validation consists of assuring that the product meets the user needs as defined by the organization. IMHO, this approach does not assure that user needs were truly met. It only confirms that we designed and built what we think the customer wanted. Consequently the argument being posed here is that this definition (of design validation) does not require that the product be taken "to the field" in either a real-world, or simulated environment to confirm that user needs were truly met. It only requires that we confirm we designed and built what we thought the customer needed.

The 2nd definition, lacking the term "defined" would seem to obligate the organization to truly confirm that user needs were met - not just what the organization (Marketing, Engineering, etc) thought the customer required. Consequently, this definition of design validation would seem to obligate the manufacturer to perform a real world, or simulated environment confirmation.

Again, a subtle but potentially significant difference & one which I am posing to the "best & brightest" here at the Cove! Thank you for your patience!
I'm not an expert in this area, but using definition #2, how could "..device specifications conform with user needs..." if user needs haven't been defined? In other words, isn't the "defined" requirement of definition #1 at least implicit in definition #2?
 
W

Watchwait

#3
Re: FDA QSR Inconsistency?

I'm not an expert in this area, but using definition #2, how could "..device specifications conform with user needs..." if user needs haven't been defined? In other words, isn't the "defined" requirement of definition #1 at least implicit in definition #2?
Jim,To your point, they could not & yes, to that degree "defined" would be implicit in Definition #2. That aside, the real question remains:

Is the "intended purpose" of Design Validation (in the eyes of FDA) to:

a) Confirm that we made what Marketing thought the customer wanted

- or -

b) Confirm that we made what the customer needed?
 
P

Phil Fields

#4
Re: FDA QSR Inconsistency?

Folks,

I've come across something that may be old news to many of you - but I've just noticed it and "it" is creating somewhat of a "discussion" in my organization...

21CFR, Part 820, para 820.30(g) defines Design Validation as follows: "Design Validation....Design validation shall ensure that devices conform to defined used needs and intended uses..."

The FDA Medical Device Quality Systems Manual:
A Small Entity Compliance Guide
First Edition, HHS Publication FDA 97-4179, December 1996, Chapter 3 defines Design Validation as follows: "Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s)."

Conspicuously absent from this 2nd definition is the word "defined". If I may go on just a bit...

Using the 1st definition, an organization is responsible for defining and interpreting "user needs". Following this, we develop products which we hope will meet these user needs - again as defined and interpreted by the organization. Once developed, the design validation consists of assuring that the product meets the user needs as defined by the organization. IMHO, this approach does not assure that user needs were truly met. It only confirms that we designed and built what we think the customer wanted. Consequently the argument being posed here is that this definition (of design validation) does not require that the product be taken "to the field" in either a real-world, or simulated environment to confirm that user needs were truly met. It only requires that we confirm we designed and built what we thought the customer needed.

The 2nd definition, lacking the term "defined" would seem to obligate the organization to truly confirm that user needs were met - not just what the organization (Marketing, Engineering, etc) thought the customer required. Consequently, this definition of design validation would seem to obligate the manufacturer to perform a real world, or simulated environment confirmation.

Again, a subtle but potentially significant difference & one which I am posing to the "best & brightest" here at the Cove! Thank you for your patience!
Suggestion: Obtain a copy of "The Quality system Compendium", this is available from the Association for the Advancement of Medical Instrumentation (AAMI). The Compendium lists each of the paragraphs form 21 CFR Part 820. This list has two discussions, one from the FDA view, and one from the industry view. I think that this book will answer your questions.

Phil
 

Wes Bucey

Quite Involved in Discussions
#5
Re: FDA QSR Inconsistency?

Jim,To your point, they could not & yes, to that degree "defined" would be implicit in Definition #2. That aside, the real question remains:

Is the "intended purpose" of Design Validation (in the eyes of FDA) to:

a) Confirm that we made what Marketing thought the customer wanted

- or -

b) Confirm that we made what the customer needed?
My suggestion is not to overthink this. If we give a medical patient (or his caregivers) what he needs, it would be an "instant cure" for whatever ails the patient, from a scraped knee to cancer. Universal instant cures are not yet realistic. Therefore, the producer of the product or drug or service says, "I am aiming the use of this (product or service) to answer this specific need of a patient ________ ."

If you think about it, almost every item or product has a defined need or niche proposed by the manufacturer. In the case of drugs, for example, some doctors go BEYOND that defined "need" and prescribe drugs "off label" for some conditions. Until recently, one of the most often prescribed "off label" uses for quinine tablets was for treatment of nighttime leg cramps, although the label strictly defines them for use as an antimalarial symptom drug. In the past few years, FDA has cracked down on the off label use of quinine and is considering several other drugs for similar policy enforcement. There is a brief treatise on a law firm page here http://www.oshmanlaw.com/pharmaceutical_litigation/quinine.asp
but you can google for other sources on the situation.

A potential solution:
One of the most used phrases of trite aphorisms in my arsenal is
"When in doubt, ask the source or authority with whom you will have to deal." (Often used in the context of Contract Review.)

I might even start with FDA's ombudsman to get directed to the proper source to answer my query:
FDA Office of the Ombudsman
5600 Fishers Lane, Rm. 13B-07
Rockville, MD 20857
Phone: 301-827-3390
Fax: 301-480-8039
Email: [email protected]
 
W

Watchwait

#6
Re: FDA QSR Inconsistency?

Wes, I take it you are in the drug industry? (Just curious).

That aside, your wisdom of referring to the source we ultimately need to deal with speaks volumes. In this case (and I would suspect most cases) it is the customer - who happens also to be the user.

Erring to the conservative, I cannot imagine any circumstance where FDA, during a facility audit or 510(k) submission review, would NOT expect that design validation circle back to user needs. Clealry, the intended purpose of Design Validation is to determine whether an organization has successfully assessed, interpreted and implemented user needs.
 

Wes Bucey

Quite Involved in Discussions
#8
Re: FDA QSR Inconsistency?

Wes, I take it you are in the drug industry? (Just curious).

That aside, your wisdom of referring to the source we ultimately need to deal with speaks volumes. In this case (and I would suspect most cases) it is the customer - who happens also to be the user.

Erring to the conservative, I cannot imagine any circumstance where FDA, during a facility audit or 510(k) submission review, would NOT expect that design validation circle back to user needs. Clealry, the intended purpose of Design Validation is to determine whether an organization has successfully assessed, interpreted and implemented user needs.
Wes, I take it you are in the drug industry? (Just curious).

Not really. One of the ASQ Sections I belong to has dozens and dozens of members from Abbott and Baxter - two big houses under FDA regulation. Abbott paid a humongous penalty recently (a few years ago) for not paying attention to EXACTLY what FDA required and paid millions in lost business and consultant fees to bring a manufacturing line shuttered by FDA up to a level to get it reopened.

Some organizations have fought FDA rulings and won, but even then, they didn't win money settlements against FDA for the cost of the battle.

Much better in my opinion to defuse a potential adverse ruling after the fact by getting direct guidance before the act. When I was in the investment banking business, we used to routinely get advance rulings (not just guidance) from the IRS for schemes that were close to the edge for saving taxes on mergers and acquisitions and on issuance of tax-exempt revenue bonds. The IRS has pretty much stopped the practice of issuing advance rulings and the result has been some reckless lawyers and accounting firms have led individuals and organizations into big trouble with erroneous advice (witness actor Wesley Snipes and his upcoming sentence of 3 years!)
 
M

maxwell

#9
Re: FDA QSR Inconsistency?

This discussion has been on going at my company for a while, management is of the opinion that testing of the device to performance standards is design validation. When I contacted the FDA for clarification I got the standard reply " it is up to the manufacturer to determine how they meet the design validation requirement" It would seem to me ideally simulated or actual use by end the end user would be nice, but real world this could have significant cost impacts.
 
P

Phil Fields

#10
Re: FDA QSR Inconsistency?

Watchwait
You say that you company HOPES to meet the user needs, and that you THINK that you built what the customer wanted.
How does your company base its design criteria? Does it use customer feedback on existing product, do you use BETA products for the customer to use?
How do you know that you are not developing a product that is used opposite of what other similar products on the market are?
How does your company INTERPRET the customer needs?


Phil
 
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