Just because your medical device is considered “low risk” and “simple” doesn’t mean your regulatory process follows the same path.

Did you know, some of the most frequent problems in medical device manufacturing/sales revolve around missing regulatory documentation and process controls? These “gaps” are often due to an assumption that class I devices are exempt from serious regulatory controls.

It’s a myth to presume any medical device is exempt from FDA controls.

Some of the most common misconceptions can be seen here.

Myth:
We use contract manufacturers to make our products. If they are registered with the FDA we don’t need to worry about FDA registration ourselves.

Truth:
If your company has designed and sells a medical device (regardless of the class) your company is responsible for registering with the FDA and paying the annual registration fee.

Myth:
Our contract manufacturers are ISO 13485 certified and follow cGMPs. This certification will assure that the factory takes 100% responsibility for quality assurance and FDA quality system documentation.

Truth:
your company is the ultimate responsible party for any manufacturing defects, tainted materials or safety problems associated with your product. It’s your company that will be liable for problems in the end. Your company must take charge of educating your suppliers about correct product specs, materials and functionality. Arm your suppliers with as much data about your product requirements as possible. Any medical manufacturing will require intense project management to assure all tests, certificates and process are being documented and followed correctly.

Myth:
We don’t need an FDA quality system manual if we contract out manufacturing.

Truth:
If your class 1 product is sterilized, the FDA mandates that your company creates and follows a full FDA QSR manual documenting all manufacturing processes and procedures. This is information that you must provide to your contract manufacturers and sterilizers. Be prepared to budget for the development of a quality system manual and possible sterilization validation.

Myth:
Our product is exempt from cGMPs. We don’t need to worry about documenting any FDA QSR manufacturing processes.

Truth:
Your company will be responsible for developing a process and tracking system for managing medical device recalls and complaints. No medical device company is exempt from managing product safety.

The broad lesson to keep in mind; presuming a simple product will lead to simple regulatory controls can ultimately increase your corporate risk and potentially harm patient safety.
A good rule of thumb to follow: presume your medical device will require some FDA regulatory and compliance controls well before you begin development and sales. This mind set will help you focus in on what may be required by the FDA (instead of attempting to avoid the FDA) to successfully sell your products in the market.