Aug 8, 2016
US medical device regulators have issued new recommendations for determining when changes to a registered medical device require filing a new 510(k) application.
The US Food and Drug Administration first published such recommendations in 1997; in its new draft guidance, the agency intends to clarify various points including a particular phrase—“could significantly affect the safety or effectiveness of the device”—that has complicated some manufacturers’ attempts to determine whether changes to their devices do indeed necessitate new 510(k) filings.
Emergo Vice President of Quality Assurance Consulting Richard Vincins says the new draft guidance has taken more industry feedback into account than the last time the FDA attempted to update recommendations for changes to 510(k) devices in 2012 and 2013.
“This time the FDA has published guidance that, after a brief review, seems to have acknowledged and added a few suggestions from industry that were raised previously,” Vincins explains.
“And more interesting is a separate guidance just for changes to software,” he adds.
(Emergo will provide analysis of the FDA’s new medical software guidance in a separate blog post.)
“Guiding principles” for new 510(k) determinations
The new guidance contains several “guiding principles” that manufacturers should utilize when deciding whether to submit new 510(k)s for changes or modifications to their devices, including:
Key types of changes that may require new 510(k)s
The guidance divides types of device changes that could require new premarket notification into three broad categories: labeling changes; technology, engineering or performance changes; and materials changes.
Regarding labeling changes, the FDA notes that changes made to intended use versus indications for use are a crucial distinction when determining the need for a new 510(k) filing. Examples of indications for use changes on labels that usually do require new 510(k)s are:
On the other hand, the following examples of label changes would likely not require new premarket notification applications:
Technology, engineering and performance changes should prompt several questions and evaluations by manufacturers to decide whether to file new 510(k) applications:
Finally, some types of device materials changes to devices do require new 510(k) filings, and often also result in substantial labeling or specification changes, compounding the need for new premarket notification.
Factors manufacturers should consider when it comes to material changes include:
The guidance includes flow charts for all three major types of device changes discussed above.
The US Food and Drug Administration’s revised Refuse to Accept (RTA) policy is now in effect.
The RTA policy involves an early review of 510(k) applications to determine whether they are “administratively complete,” or contain all materials necessary for the regulator to conduct a substantive review.