What am I? Specification Developer or R&D Firm?

P

potato124

#1
Hello,

I am with a company that recently designed, developed, and submitted a 510(k) for approval for a Class II device. Once we obtain approval, we will exclusively license the design and the 510(k) to a manufacturer partner. That manufacturer will then sell that device to US distributors, with the US distributors name on it.

1) Is my company the spec developer? The regs say that a spec developer "Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment?s name by a contract manufacturer."

It seems the term "spec developer" is on the marketing side, after 510k is obtained.

2) Do you have to be a spec developer to file a 510(k)? Can you simply be an R&D firm that has the appropriate Design Control systems in place?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

My answer below is based on the understanding (assumption) that once you license the design you won't have any involvement in the making and marketing of the device, and it will be placed on the market under the name of the licensee. If this is not true, the rest of this post may be irrelevant.

If you are not involved in the physical making and distribution of the device, you probably don't have to register. Titles such as "Specification Developer" are only relevant for those who must register. In my understanding, you won't qualify as a Specification Developer, even though you actually developed the specification; this is because you won't be involved in the process of bringing the device to use. Your licensee will be some kind of "Manufacturer", will probably have to register and bear regulatory responsibility for the device as such.

510(k) submission has little to do with all that. Any one that has rightful access to the required information can submit a 510(k).

Cheers,
Ronen.
 
P

potato124

#3
Thanks for the reply Ronen. So I think I am clear - to submit a 510(k), you don't have to be a spec developer or to be registered for that matter. Prior to going to market, the manufacturer must list the device...got that part.

Now, suppose my company wants to buy product from that manufacturer and sell (with my name on it) into a limited number of hospitals. Other large medical device companies already do this with them - the manufacturer labels product with the customer's name, and then their sales force gets it into hospitals. My company would like to do the same. What are we at that point? Are we a spec developer since we are telling the manufacturer what type of product we want to buy? Or, are we a domestic distributor? The registration and listing requirements are quite different.

If we are a spec developer, is it ok to have the same device listed twice, by us and the manufacturer?
 
M

MIREGMGR

#4
Now, suppose my company wants to buy product from that manufacturer and sell (with my name on it) into a limited number of hospitals. Other large medical device companies already do this with them - the manufacturer labels product with the customer's name, and then their sales force gets it into hospitals. My company would like to do the same. What are we at that point? Are we a spec developer since we are telling the manufacturer what type of product we want to buy? Or, are we a domestic distributor? The registration and listing requirements are quite different.
Every device must be primarily one company's regulatory responsibility. If the actual fabricator is the Manufacturer with a big M, i.e. they both make the device and have regulatory responsibility for it, then there is no Specification Developer. If you and the actual fabricator have agreed that you will be regulatorily responsible for the device, you are the Specification Developer and they are a Contract Manufacturer.

In any case, FDA does not (normally) regulate domestic distributors, including distributors who arrange to have the product Private Labeled for them. So, you could be both a Specification Developer and a distributor without the two roles conflicting.

If we are a spec developer, is it ok to have the same device listed twice, by us and the manufacturer?
In that case, the "manufacturer" in fact is a Contract Manufacturer, and under the 2013 rules it's not only OK for each of you to List the device...it's mandatory. Note that you as the Spec Developer have to List first.
 
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
S Are we the Specification Developer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
M Who is the Specification Developer in this case? ISO 13485:2016 - Medical Device Quality Management Systems 10
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