FDA consults surgical device experts on down-classing certain hemostatic agents

Dive Brief:

FDA could loosen premarket expectations for certain absorbable collagen-based hemostatic agents marketed by companies like Integra LifeSciences and Johnson & Johnson's Ethicon, depending on recommendations Friday from the General and Plastic Surgery Devices Panel. Ethicon opposes down-classing the devices.
The agency wants the panel's input on whether to continue reviewing the devices as Class III products, requiring a premarket approval (PMA) application, or to shift to regulating the devices with general and special controls (Class II). The products in question are meant to produce hemostasis by speeding up the clotting of blood, particularly in cases when cautery or ligation are not sufficient or a site is too inaccessible for easy use of conventional methods.
The potential down-classing would notably exclude absorbable collagen-based hemostatic devices containing added biologics and non-collagen-based absorbable hemostatic agents, which are both set to remain in Class III.

Dive Insight:

FDA published a retrospective review of Class III devices in 2015 and identified absorbable collagen-based hemostatic devices as potentially appropriate for a Class II reclassification.

Absorbable collagen-based hemostatic devices can be especially popular in minimally invasive surgeries as a means to clot blood in harder-to-reach areas, or as a second line of defense when conventional methods don't prove sufficient to control bleeding.

The gelatin sponge or microfibrillar collagen agents are typically administered via a syringe-like accessory, FDA said, and have required premarket applications to come to market since the 1970s. The devices up for reclassification "do not promote clotting in a biologically active manner or work in combination with thrombin," FDA said.

FDA estimated that in 2012 alone, the devices were used in more than 6.9 million procedures. That figure contextualizes the 165 total related medical device reports FDA said it received between July 24, 2003 and Dec. 31, 2018. Eight deaths were reported, three of which occurred in cases of off-label use, FDA said.

In an extensive literature review, FDA said the majority of adverse events were related to hemostatic devices containing thrombin, which are not up for reclassification.

While FDA has received medical device reports citing infection and allergic reactions, and has cited other risks like failure to absorb and simply failure to control bleeding, the agency believes special controls can sufficiently control risk.

"Although adverse events associated with absorbable collagen-based hemostatic devices may result in loss of life and significant loss of function, the incidence of adverse events for absorbable collagen-based hemostatic devices is low compared to the large number of surgeries performed with these devices," FDA wrote in meeting documents.

Ethicon disagreed.

"Ethicon believes absorbable collagen-based hemostats should remain as Class lll devices due to the complexity of these products and the fact that strict controls are needed to ensure the safety and effectiveness of these products for their intended use," spokesperson Ann Leibson said in an email to MedTech Dive.

Proposed special controls the panel will weigh include certain biocompatibility, performance and usability testing, as well as detailed labeling.

The General and Plastic Surgery Devices Panel also met Thursday to discuss FDA up-classing surgical staplers for internal use, which panelists unanimously supported.