I am a new comer and really glad to meet so many QMS experts here.
As I read FDA 21 CFR Part 820.1, it described that "This part establishes basic requirements applicable to manufacturers of finished medical devices." I am confusing what is the definition of finished medical devices,
1. a individual finished devices?
2. a full package finished devices?
3. a box-built devices?
Others?
It seems that only the manufactuer of the finished medical devices shall be requested to follow FDA QSR, so I would like to see whether we need to follow or not. Please kindly advice. Many thanks.

A "finished MD" is IMHO a ready-to-use medical device.

Since many devices are more or less complex, many production steps are outsourced. These (sub)parts are not "finished devices".

So primarily manufacturers of finished devices have to follow the QSR. Often manufacturers have discrete quality agreements with subcontractors, which may (but not must) include the QSR (or other) as a requirement for the subcontractor.

Thanks wrodnigg,

One more concern regarding to your reply. If all (sub)parts are out-sourced to different manufacturers, is only the final box-built (package) manufacturer act as a manufacturer of finished medical devices.

Many thanks.

I am more familiar with the European regulatory requirements:

According to the Directives 90/385/EEC, 93/42/EEC or 98/79/EC the person who takes regulatory responsibility for the product is “the manufacturer”. The Directives define the manufacturer as:

‘manufacturer´ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

The manufacturer is therefore the person who places the device on the European market "under his own name". This person must take full regulatory responsibility for meeting the requirements of the Directives regardless of who physically performs the design, manufacture, packaging and labelling of the device. The Directives allow some of the regulatory roles to be delegated to the manufacturers Authorised Representative if the manufacturer is based outside Europe but the manufacturer still takes ultimate responsibility.

This can also mean that distributors who inappropriately apply their name, address or logo to a product and make it larger or more prominent than the original manufacturer can be classed as “the manufacturer”.

According to the Directives 90/385/EEC, 93/42/EEC or 98/79/EC the person who takes regulatory responsibility for the product is “the manufacturer”.
The manufacturer is therefore the person who places the device on the European market "under his own name". This person must take full regulatory responsibility for meeting the requirements of the Directives regardless of who physically performs the design, manufacture, packaging and labelling of the device. The Directives allow some of the regulatory roles to be delegated to the manufacturers Authorised Representative if the manufacturer is based outside Europe but the manufacturer still takes ultimate responsibility.

This can also mean that distributors who inappropriately apply their name, address or logo to a product and make it larger or more prominent than the original manufacturer can be classed as “the manufacturer”.

wrodnigg,

I thought that the Authorised Representative had regulatory responsability. Moreover as the Auth Rep has to appear on the device's labelling, when the said AR is also the European distributor then the Device is put on the market by the distributor with it's name on it, even without chnaging the claims of the product.
In this case would you consider the Authorise Rep as the "Manufacturer" in the way the Directive defines it i.e. the person with full regulatory responsability?

Thanks wrodnigg,

One more concern regarding to your reply. If all (sub)parts are out-sourced to different manufacturers, is only the final box-built (package) manufacturer act as a manufacturer of finished medical devices.

Many thanks.

Clarence,
My understanding is that what makes a Medical Device is the claim(s) you have on your product's use.
So if you subcontract bits and pieces to different companies making those bits to your specs and selling them to you as OEM or "parts" of a final product. Only the final assembler acts as a manufacturer as it builts up a system and gives it claims of use which show medical use of this very final product.
So it's the final manufacturer's responsibility to make sur the parts are manufactured according to it's needs.

There is a specific case in the field of iVD (in vitro diagnostic) Medical Devices. It's the ASR case (Analyte Specific reagent), those are reagents which are manufactured to be part of an IVD. in this case the manufacturer gives some "intention of use" to the reagent and needs to register with FDA and declare that the product is manufactured in a qSR compliant environment but there is no need of pre market approval for the reagent.

hope my thread throws light rather than darkness and confusion


Vincnet

Vincnet ~ Thanks for your kindness help, and I got three different cases that we are facing, would you help to verify,
Case,
1. if the iVD is owned by A company, the devices is made by B company, reagent is made by C company, then A company will be act as the manufacturer, right?
2. if the iVD is owned by A company, the devices is made by B company, reagent is made by C company, the box-built is done by D company, A & D company will be act as the manufacturer, right?
3. but if the iVD is still owned by A company, the devices is made and box-built by B company, and the reagent is made by C company, then A & B company shall also act as a manufacturer, right?

Once again, your reply should be greatly appreciate.

From 21cfr820.3

(l) Finished device means any device or accessory to any device that
is suitable for use or capable of functioning, whether or not it is
packaged, labeled, or sterilized.


(o) Manufacturer means any person who designs, manufactures,
fabricates, assembles, or processes a finished device. Manufacturer
includes but is not limited to those who perform the functions of
contract sterilization, installation, relabeling, remanufacturing,
repacking, or specification development, and initial distributors of
foreign entities performing these functions.

The manufacturer is usually the party listed on the label and is responsible for the placing the device on the market and must comply with the QSR but may require subcontractors who provide component parts of a device to comply with sections of the QSR such as process controls.

From 21cfr820.3

(l) Finished device means any device or accessory to any device that
is suitable for use or capable of functioning, whether or not it is
packaged, labeled, or sterilized.


(o) Manufacturer means any person who designs, manufactures,
fabricates, assembles, or processes a finished device. Manufacturer
includes but is not limited to those who perform the functions of
contract sterilization, installation, relabeling, remanufacturing,
repacking, or specification development, and initial distributors of
foreign entities performing these functions.

The manufacturer is usually the party listed on the label and is responsible for the placing the device on the market and must comply with the QSR but may require subcontractors who provide component parts of a device to comply with sections of the QSR such as process controls.

So the main point is, "Will FDA inspect/audit the contract manufacturer/subcontractors?"

So the main point is, "Will FDA inspect/audit the contract manufacturer/subcontractors?"
Bottom line. Prepare for thje worst and hope for the best. The FDA can inspect your faciliy if you are a registered contract manufacturer providing a critical process to the manufacture of the device.

Bottom line. Prepare for thje worst and hope for the best. The FDA can inspect your faciliy if you are a registered contract manufacturer providing a critical process to the manufacture of the device.

Thanks. ^.^