Regulatory Focus™ > News Articles > 2019 > 7 > Medtronic, J&J Back Surgical Stapler Reclassification but Raise Concerns Over New Controls

Medtronic, J&J Back Surgical Stapler Reclassification but Raise Concerns Over New Controls

Posted 03 July 2019 | By Ana Mulero 

Medtronic, J&J Back Surgical Stapler Reclassification but Raise Concerns Over New Controls

Medtronic and Johnson & Johnson (J&J) showed support for efforts at the US Food and Drug Administration (FDA) to reclassify surgical staplers from class I to class II with some caveats, particularly as it relates to retroactively imposing new special controls on devices already in clinical use.
 
In response to an analysis of more than 41,000 individual medical device reports, FDA issued draft guidance in April on labeling special controls for surgical staplers and staples in conjunction with a proposed reclassification of the devices.

In their comments, Medtronic and J&J echo recommendations from an advisory committee meeting FDA convened in May to debate whether surgical staplers should be reclassified. They see eye-to-eye in terms of needing premarket notifications or 510(k)s for all surgical staplers prior to being put into clinical practice. 
 
However, both companies say that their surgical staplers underwent 510(k) review prior to market entry and request that FDA confirm the products were manufactured in accordance to the agency’s proposed special controls.
 
“We request that FDA provide affirmative confirmation that our products meet these new expectations and if not, grant an expedited presubmission (Q submission) meeting for all impacted manufacturers to discuss the assessment and align on the pathway forward (e.g. letter to file, 510(k) submission),” J&J writes.
 
Medtronic cautions that the rule could adversely impact access to surgical staplers if FDA were to retroactively review products that are already in clinical use. The company “explained that conducting additional bench and animal testing on devices that have been in clinical use for many years and have an established safety profile is unlikely to provide clinically meaningful information and, in fact, may adversely affect patient access,” Medtronic writes.
 
The panel and the companies generally supported the proposed special controls on new devices. Yet “some panel members felt that certain warnings in the labeling special controls...should be removed as they believed the labeling should allow the surgeon to exercise their own clinical judgment rather than dictating surgical practice,” according to FDA’s 24 hour summary of the panel’s recommendations.
 
The consensus rests on providing better support for using the surgical staplers via surgeon training and appropriate product labeling while avoiding interference with surgical practices.

Both Medtronic and J&J also cite a lack of recognized consensus standards on some proposed parameters, including firing force, burst strength and the percentage of properly formed staples.
 
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