With the recent trends of US companies turning to companies in China and other foreign countries to manufacture the medical devices that US companies develop and market, there is increasing regulatory scrutiny and confusion among firms engaging in such relationships resulting in increased costs for all parties involved.

This article provides both US firms and foreign contract manufacturers Advanced Biomedical Consulting's (ABC) simplified explanations for each organization's current regulatory responsibilities and best practice recommendations.

How Does FDA Classify A Firm?

Is your company a manufacturer, contract manufacturer, specification (spec) developer or what? This is often misunderstood by not only foreign companies involved in medical devices but also for companies right here in the US! However, it is extremely important to know how FDA classifies a business prior to deciding on a relationship between firms.

Specification Developers

While this term is a bit misleading, the simple interpretation is that a specification or "spec" developer is any firm that has its "name" on the finished device product but does not manufacturer the finished device in-house. In FDA's eyes, the spec developer has overall responsibility for the safety and effectivness of the product and regulatory compliance of all facilities manufacturing its product. Yes, this even means full responsibility for external companies manufacturing its products.

Manufacturers

A manufacturer is any firm that has its "name" on the finished device product and manufactures the finished device in-house. In FDA's eyes, manufacturers have full responsibility for the product they develop and distribute.

Contract Manufacturers

A contract manufacturer is any firm that has its customer's "name" (i.e. the spec developer) on the finished device product and manufactures the finished device in-house. In FDA's eyes, contract manufacturers have full and equal responsibility for the product they manufacture for their customers.

Who Has to Register and List with FDA?

FDA has waffled over these rules over time. However, currently only spec developers and manufacturers have to register and list products (both electronic processes) with FDA. Different than in the pharmaceutical world, it is important to know that contract manufacturers currently DO NOT have to register or list products with FDA. However, it is key to understand that just because the contract manufacturer is not required to register, that does not mean that it does not have to comply with the Quality System Regulations (QSRs).

Who Is Responsible for Compliance?

As briefly discussed above, both the spec developer AND the contract manufacturer are responsible for FULL regulatory compliance associated with the manufacturing of the product. However, it is the spec developer that needs to thoroughly ensure ongoing compliance. For example, FDA may audit a spec developer's contract manufacturing, generate observations, and never inform the spec developer at all of the audit. Conversely, if there are major issues, FDA will inform the spec developer and then quite often will turn around and audit the spec developer to ensure that the firm has done an acceptable job of ensuring compliance at its contracting manufacturer's site. As can be assumed, especially with using foreign contract manufacturers, FDA nearly always discovers that the spec developer has not done an adequate job in ensuring compliance at its contract manufacturing facility, finds other aspects of why the spec developer is not complying with non-manufacturing related aspects of the QSR, and hence a regulatory/legal battle among all parties ensues.

A Simple Checklist

So, how can foreign contract manufacturers and spec developers ensure a successful relationship without finger pointing battles and hidden costs showing up later on? The answer is with a simple "checkllist".

When initiating a relationship, the spec developer needs to verify and document that the following items are in order and fully understood and agreed upon by the contract manufacturer prior to signing on the dotted line. These items are usually specified in a formal manufacturing or quality agreement.

 

In addition, the spec developer needs to ensure ongoing compliance (i.e. site audits) at its vendor's site(s). As most spec developers are more experienced in development and marketing than actual manufacturing, often firms hire cost-effective consulting organizations like Advanced Biomedical Consulting (ABC), LLC to manage and execute these audits and ensure that corrective and preventive actions (CAPAs) are implemented.

For more information about how to cost-effectively develop and maintain a contract manufacturer/spec developer relationship, feel free to contact ABC here for a no obligation quote. If you contact ABC before 04NOV10 and mention this article, ABC will offer 15% OFF our standard rates for compliance assessment and vendor audits.

So, take advantage of this opportunity today to save your organization valuable dollars and still get the help you need!

Saint Petersburg, FL - October 08, 2010)