The Benefits of using Standards when Marketing Medical Devices

In order to sell Medical Devices in the U.S., companies must submit a premarket application (i.e., Premarket Notification (510(k)), Investigational Device Exemptions application (IDE), Premarket Approval application (PMA), Humanitarian Device Exemption application (HDE), or Product Development Protocol (PDP)).  These applications provide the information that’s required by law (and regulations) to allow FDA to make an appropriate decision regarding the marketing of the device.

One way to simplify and speed up the process is to use standards. Conformance with standards can satisfy these premarket review requirements.  The FDA states that “conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.”

You’ll need to use FDA-recognized consensus standards.  They are particularly useful when they serve as a complete performance standard for a specific medical device. In these cases, the standard may include specific acceptance criteria that describe the relevant performance characteristics for a specific medical device. Conformity can minimize the amount of data and documentation needed in the 510(k) submission, but such standards are rare.

However, conformance to other more general vertical standards (i.e., device specific standards that may not encompass all aspects of device performance) can also serve as a means to streamline the premarket review process. Using any recognized consensus standard that clearly spells out acceptance criteria is a very effective use of this type of document in the premarket process. This means the use of FDA recognized standards can reduce the amount of documentation to submit and may reduce the FDA’s review time as well.

At this time, there are actually 813 standards that are accepted by the FDA.  Compliance is confirmed by a declaration of conformity which is included with the premarket application submission.  With adequate justification for the acceptance criteria and for any deviations from the standard, FDA can usually accept a declaration of conformance without the need to review test protocols and analyze the raw data.

For a list of the Recognized Consensus Standards, or for any other question on Medical Device standards, please contact us at info@document-center.com or by phone (650-591-7600) or fax (650-591-7617).  Medical Device standards can be purchased on our website, www.document-center.com.