Are we the Specification Developer?

M

MIREGMGR

#11
Actually this gets at a subtle but important distinction.

The OP is asking in post 5 of the thread what their QMS needs to include if their role is Specification Consultant. In that role, they don't have any regulatory responsibility for the product, and therefore an analysis based on product responsibility--done by either the responsible marketer or the OP--would conclude that their QMS isn't required to include anything.

My take though would be that even though they do not have primary responsibility for the work they do because the responsible marketer has primary regulatory responsibility overall, they still must have a QMS that encompasses their particular activities, under a "secondary responsibility" theory.

I don't know of any documentation addressing this under the FDA system, even though I know that to be their working view.
 
Last edited by a moderator:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#12
You apply the sections that pertain to activities you do.

Typically a specification developer consultant will need at least design control, document control, and records; and possibly CAPA, design aspects of labeling/packaging, and statistical techniques.
I agree that it would be good to have all these, but according to my understanding it's not required by the regulations.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
My take though would be that even though they do not have primary responsibility for the work they do because the responsible marketer has primary regulatory responsibility overall, they still must have a QMS that encompasses their particular activities, under a "secondary responsibility" theory.

I don't know of any documentation addressing this under the FDA system, even though I know that to be their working view.
Could you please briefly lay down what you see as the main principles of that "secondary responsibility" theory, which is presumably the current FDA working view?

:thanks:
Ronen.
 
M

MIREGMGR

#14
I agree that it would be good to have all these, but according to my understanding it's not required by the regulations.
Sorry that it took me a while to get back to this.

21CFR 820.1 "Scope" says that 21CFR 820 applies to "design, manufacture, packaging, labeling, storage, installation and servicing". It also says that the requirements are applicable to "manufacturers of finished medical devices". A "manufacturer" is defined to include companies that perform "contract sterilization, installation, relabeling, remanufacturing, repacking or specification development".

My understanding of that language is that a contract specification developer, working for a company that is responsible for a finished medical device, is required to comply with all parts of 21CFR 820 except those for which an exclusion justification is documented, per 21CFR 820.1(a)(3).

My further understanding is that generally the only basis for exclusion is that the requirement is something you do not perform, and someone else does appropriately perform.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#15
A "manufacturer" is defined to include companies that perform "contract sterilization, installation, relabeling, remanufacturing, repacking or specification development".
My understanding of that language is that it should be read in the broader context, and thus the "specification development" item should be coupled to the FDA manufacturer category "specification developer", that means a company that markets a finished device under its own name while it is being physically produced by others. It should not be related to companies that don't market finished devices, and hence the "specification development" they provide is merely a component.

I agree that in the described case part 820 applies as you've indicated and the requirements applicable to the specification development should be met, but the formal responsibility for that would rest with the finished device manufacturer and not with its design subcontractor. The finished device manufacturer could delegate some of the related tasks to its design subcontractor, contractually, but not the responsibility, IMO.

Cheers,
Ronen.
 
M

MIREGMGR

#16
I agree that responsibility cannot be delegated away by a company to which that regulatory responsibility is assigned by regulation. Responsibility however can exist for a second company even though a first company already is responsible. This is the "200%" or "primary/secondary" scenario.

For instance, consider the specification provider/contract manufacturer situation, in which the specification provider is fully responsible and the contract manufacturer additionally has some elements of responsibility, depending on their involvement and actions. For a relevant example of this, see the Braun warning letter.

Note that this isn't "shared" responsibility, because each party can be gigged for failure to conform even if the other party does conform. That's exactly what FDA did in the Braun instance.
 
Last edited by a moderator:
M

MIREGMGR

#17
The finished device manufacturer could delegate some of the related tasks to its design subcontractor, contractually
When I have the time, I'll have to find a warning letter or other reference on this.

Here's a scenario: if company A, a device maker that doesn't want to do its own specification development, chooses to contract with company B to perform that specification development work, clearly company A is responsible for that work being performed according to 21CFR 820. The actual work though is performed at company B. If company B does not have a QMS that encompasses the parts of 21CFR 820 that are relevant to design control and document control, how can FDA inspect the specification development process (which is governed by 21CFR 820.30 and .40) to determine if it conforms? Certainly company A can maintain the master DMR and DHF, but these are outputs of the process, and the process itself must be inspectable.
 

Ronen E

Problem Solver
Staff member
Moderator
#18
I agree that responsibility cannot be delegated away by a company to which that regulatory responsibility is assigned by regulation. Responsibility however can exist for a second company even though a first company already is responsible. This is the "200%" or "primary/secondary" scenario.

For instance, consider the specification provider/contract manufacturer situation, in which the specification provider is fully responsible and the contract manufacturer additionally has some elements of responsibility, depending on their involvement and actions. For a relevant example of this, see the Braun warning letter.

Note that this isn't "shared" responsibility, because each party can be gigged for failure to conform even if the other party does conform. That's exactly what FDA did in the Braun instance.
You may be right, I'm not that close to FDA "field practice" and can only read the regulation and try to decipher it based on my own experience.

In my understanding there's no 1:1 correlation between the "Specification Developer / Contract Manufacturer" scenario and a "Finished Device / Component Supplier" one; the former is covered by the regulation and official written guidance in a much clearer and more specific way; qualified Contract Manufacturers must register, and they have broader direct regulatory responsibilities, while Component Manufacturers have much more limited defined roles in the regulations.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
Here's a scenario: if company A, a device maker that doesn't want to do its own specification development, chooses to contract with company B to perform that specification development work, clearly company A is responsible for that work being performed according to 21CFR 820. The actual work though is performed at company B. If company B does not have a QMS that encompasses the parts of 21CFR 820 that are relevant to design control and document control, how can FDA inspect the specification development process (which is governed by 21CFR 820.30 and .40) to determine if it conforms? Certainly company A can maintain the master DMR and DHF, but these are outputs of the process, and the process itself must be inspectable.
To this I have 2 comments:

1. Company A could (and probably should) exercise its regulatory responsibility by locking 820.30 compliance - for instance - into the contract with Company B. They could also spell out the requirement for FDA inspection at B, at the FDA's / Company A's discretion. And so on.

2. In my understanding and experience, most processes are examined for compliance by their outputs (and inputs, sometimes); certainly design processes are. You can't, for instance, probe the designer's brain to see how the design work actually occurs; instead, you would look at the outputs (the design, the calculations, the risk management files and the DHF in general). I've also never come across a FDA investigator insisting on sitting in a design review meeting, to witness "the process" or the dynamics in action, as part of a routine inspection; instead, they usually suffice with reviewing the design review report. But then again, I don't claim to have an all-encompassing acquaintance with FDA investigators.

Cheers,
Ronen.
 
M

MIREGMGR

#20
I'm definitely aware of FDA inspectors reviewing each of the letter-steps in 21CFR 820.30...QMS procedures, then how the plan, inputs, outputs, reviews, verification/validation and transfer are consistent with those procedures. The QSIT manual requires such a stepwise inspection procedure...it's right in the inspection flowchart. An inspector that only looked at outputs and the DHF would not be following procedure.

Not all QSIT 1 inspections include Design Control, but some do; and of course a For Cause inspection may, depending on the reason for the visit.

That pretty much has to be done at the site where the design work is done, and that site pretty much has to have a cGMP QMS.
 
Thread starter Similar threads Forum Replies Date
D Subcontracting specification developer duties US Food and Drug Administration (FDA) 5
S When does a Distributor become a Specification Developer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Lisa Christo Specification developer Other Medical Device Related Standards 0
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Specification Developer or Consultant? Definitions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Medical Device Manufacturer vs. Specification Developer Other US Medical Device Regulations 1
supadrai Establishment registered as specification developer and foreign exporter only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Who is the Specification Developer in this case? ISO 13485:2016 - Medical Device Quality Management Systems 10
P What am I? Specification Developer or R&D Firm? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q Establishment Registration - Specification Developer Quandry 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
W Quality Manual for Specification Developer ISO 13485:2016 - Medical Device Quality Management Systems 1
Q What are the required procedures for Medical Device Specification Developer? ISO 13485:2016 - Medical Device Quality Management Systems 24
I No validation for a contract specification and software developer? ISO 13485:2016 - Medical Device Quality Management Systems 5
I A specification developer or not? Contract design and development for a subsystem US Food and Drug Administration (FDA) 10
R Specification Developer's 510K submissions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Radius with specification only Max limit Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
G What does performance specification include? US Food and Drug Administration (FDA) 1
B Setting flexible packaging specification limits ISO 14971 - Medical Device Risk Management 4
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
T Root Cause Failure Analysis - Not following Customer packaging Specification Problem Solving, Root Cause Fault and Failure Analysis 9
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Process Specification - What is the name of this PPAP form? APQP and PPAP 15
M Procedure or Specification For Extending Gages Calibration Calibration Frequency (Interval) 2
B IATF 16949:2016 – Technical Specification (eBook edition) IATF 16949 - Automotive Quality Systems Standard 1
E Compliance to standards (ISO 80369) but the ID is out of specification Other ISO and International Standards and European Regulations 0
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
M Specifications Aerospace - Who is responsible for providing the correct specification(s) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
I EO sterilization out of specification and correction Other Medical Device Regulations World-Wide 1
R Specification on flare testing extruded aluminum - Where to find Design and Development of Products and Processes 1
M McDonnell Douglas Specification Control Drawings Various Other Specifications, Standards, and related Requirements 4
J Is there a specification that provides directions on Drawing Revision Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
S GR&R using 10 Parts with different Specification Limits Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
shimonv Soldering Station Accuracy out of specification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Accounting for Variability on High Side of Specification Reliability Analysis - Predictions, Testing and Standards 1
P Specification Subscription Services - Eg: Things like MSDS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Deformation specification not defined in print Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
R Looking for calibration specification for Fluke 7250 pressure controller General Measurement Device and Calibration Topics 5
A Uncertainty Measurement - What this accuracy specification "1% + 10^5": means? General Measurement Device and Calibration Topics 2
R ISO 13485 for Specification Developers ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom