Afternoon all
We make a small but vital part, that is built into a larger complex item of medical equipment. Do we, as potential suppliers of this medical device to the USA (via a German OEM) have to get FDA approval?
Paul, from a sunny South Wales

Afternoon all
We make a small but vital part, that is built into a larger complex item of medical equipment. Do we, as potential suppliers of this medical device to the USA (via a German OEM) have to get FDA approval?
Paul, from a sunny South WalesFrom your description, I don't believe so. From 21cfr820.50, Purchasing Contols (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.50)Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.

(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.
Additional explanation can be found in the FDA QSR Manual (http://elsmar.com/Forums/attachment.php?attachmentid=4591) Section 10 Purchasing and acceptance activities (http://www.fda.gov/cdrh/qsr/10purch.html)

Components

"Component" is defined in 820.3(c) of the Quality System (QS) regulation as any material, substance, piece, part, software, firmware, labeling, or assembly, which is intended to be included in the finished, packaged, and labeled device. For example, fasteners, blood tubing assemblies and labels are components. This definition excludes "manufacturing materials," which by definition, are not intended to be included as part of the finished, packaged, and labeled device.

According to 820.3(p), "manufacturing material" is any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer. Examples of manufacturing materials include: cleaning agents, mold-release agents, lubricating oil, or other substance used to facilitate a manufacturing process which is not intended by the manufacturer to be included in the finished device.

Manufacturers of components sold only for further manufacturing of a medical device are not required to comply with the GMP requirements for finished devices. Many components of devices, such as transistors, containers, hardware, etc., are readily available in the marketplace and are not manufactured exclusively for use in devices. Many of these manufacturers supply only a small fraction of their production to finished device manufacturers. However, section 820.1 of the Quality System regulation encourages component manufacturers to use applicable GMP elements as guidance.

If a component is manufactured in the same or proximal facility, and produced for use in finished medical devices, then the component is considered part of the production of the finished devices and is subject to the applicable requirements of the GMP requirements. If the component is manufactured in a separate plant owned by the finished device manufacturer, then the manufacturer has flexibility in handling the quality assurance activities related to the control of components. One satisfactory approach is to have the plant that builds the components operate in full GMP compliance. Under this arrangement, the plant which does the final device assembly would still be responsible for ascertaining that the quality and integrity of incoming components have not been damaged during shipment. Alternately, the component manufacturing plant may not fully comply with Quality System regulation. Then the plant that does final assembly should handle the acceptance of these components with the same degree of control as if the components were purchased from an outside supplier.

For components such as labels, package inserts, packaging, etc., there is additional information in chapter 11, Labeling; and chapter 13, Packaging.

Thanks Al for making my life easier.
If we were to market the product ourself, it would open up a big scary new world for us in the form of an FDA approval, but as a supplier, our customer has the hassle.
Paul

I believe that Al is correct in that the direct application of FDA quality regualtory requirements may not apply but there may be contractual quality assurance and/or control requirements imposed in the purchase document by the prime contractor in the US and flowed down to you as a supplier.

As a key or critical component supplier the likelyhood of this I would say is very good especially if they are required to comply with 21 CFR Part 820 which is dependent on the device classification.

My initial plan is to get my systems working to conform to 21CFR820 et al, if and when our prime contractor seeks an audit, we will be ready.
Paul
Swansea, in the snow