FDA Issues Draft Guidance on Device Changes That Require New Premarket Submissions

July 26, 2011—The US Food and Drug Administration (FDA) announced that it has issued draft guidance that clarifies FDA rules about when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

“We are making the regulatory process for medical devices less challenging by better describing our expectations,” commented Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH). “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”

According to the FDA, the draft guidance clarifies the types of changes that trigger the need for a new submission, such as specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacturing of the device.

The agency advised that written comments and suggestions may be submitted at any time for consideration to the FDA's Division of Dockets Management at the address provided in the draft guidance document. Comments may not be acted upon by the agency until the document is next revised or updated.

This draft guidance is one of 25 action items listed in the CDRH's Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability, consistency, and transparency of the agency's premarket review programs, stated the FDA.

In June, the CDRH issued its standard operating procedures on “Notice to Industry” letters. The document describes CDRH's process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect, data submitted as part of an investigational device exemption or premarket submission, including a premarket notification 510(k), a premarket approval, or a humanitarian device exemption that needs to be disseminated in a timely manner.

The document states that, where appropriate, CDRH will communicate new expectations as Notice to Industry guidance letters, which will comply with good guidance practices, or CDRH will communicate other new scientific information as Notice to Industry advisory letters. The center will post both types of Notice to Industry Letters on its Website and will use additional methods for distributing the letters to identified stakeholders.