Regulatory Editor

We're told the devil is in the details, a maxim that would seem to apply to the FDA's January 2017 draft guidance for 510(k) filings for bone anchor devices. The agency had proposed that filings for general suture anchors include "fully dimensioned engineering drawings" for all device components, but the Advanced Medical Technology Association (AdvaMed) said this requirement exceeds the requirements for 510(k) filings, which are typically satisfied by a summary device description.

The bone anchor 510(k) draft was undertaken to update a 1996 guidance for testing of bone anchors, and covers several types of anchors, although devices that attach bone to bone and devices that attach ligaments or tendons to bone are outside the scope of the draft. The FDA said filings should include device descriptions for general suture anchors that would include "fully dimensioned drawings for all device components," along with a description of how those components are assembled, assuming there are multiple components. (See Medical Device Daily, Jan. 9, 2016.)

Tara Federici, vice president for technology and regulatory affairs at AdvaMed, said in comments to the docket that requiring fully dimensioned drawings for all device components "exceeds the concept and mandate of the 510(k)," noting that a summary device description is ordinarily all that is required for class II devices. Federici added that fulfillment of this requirement could trigger a need for a new 510(k) in that minor changes to a drawing could be interpreted by reviewers as a change of sufficient significance to unnecessarily raise questions about the impact of those features on device performance.

Federici further asserted that the exclusion of bone-to-bone, ligament-to-bone and tendon-to-bone anchors is inappropriate because there are a number of cleared suture anchor devices that use artificial graft materials that are intended for repair and/or reconstruction. She also made the case that the exclusion of devices under product code HWC as possible predicates ought to be stricken from the draft.

The draft spelled out a number of features for biocompatibility testing that would have to be addressed in a 510(k) filing, a list that includes cytotoxicity and genotoxicity, but Federici said this portion of the draft "is redundant" to an existing FDA guidance for biocompatibility testing. She recommended the agency restrict the list of items subject to biocompatibility requirements under ISO 10993-1 to device-specific features, such as items that would be in permanent contact with bone tissue, and exclusive of instruments that would be only in temporary contact with bone.

Another point of redundancy in AdvaMed's view is a section on pyrogenicity, which Federici said runs the risk of conflicting with the January 2016 final guidance for sterility for devices labeled as sterile. She further suggested the agency purge the reference to bacterial endotoxin and rabbit material-mediated endotoxin testing for any device to be labeled as non-pyrogenic.

In another shot in the least burdensome wars, Federici suggested that the draft was out of bounds when suggesting that performance testing could be required when the new device employs different materials or technology from a predicate, even when those differences do not raise different questions regarding safety or effectiveness. She pointed out that existing guidance stipulates that clinical testing be required only when technological or material differences raise that question.


The November 2016 FDA draft guidance for labels attached to ultrasonic surgical aspirator devices made clear the agency prefers that such devices not be used to remove uterine fibroids, but Dublin-based Medtronic plc indicated in comments to the docket that the draft could be more clear on which devices under a particular product code are subject to this contraindication.

The draft guidance acknowledged that ultrasonic surgical aspirators are used to debulk a number of tumor types, but that labeling for a number of these devices allows for their use in removal of uterine fibroids even in the absence of an explicit indication. The draft arrived after the agency undertook extensive efforts to tamp down on the use of power morcellators for removal of uterine fibroids, although not all clinicians are on board with the impact of the FDA's stance on power morcellation. (See Medical Device Daily, Nov. 11, 2016.)

Michael Morton, VP for corporate regulatory affairs at Medtronic, said the product code LFL covers both aspirators and dissectors, the latter of which typically does not include channels for tissue irrigation/aspiration found in the former. He noted further that dissectors are not ordinarily used "for debulking of masses with associated tissue fragmentation," and that the agency might clarify this distinction to the benefit of device makers and reviewers at the Office of Device Evaluation. Morton recommended the agency reword the draft to state that ultrasonic surgical aspirators are "not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."

Also sounding off for the docket was Integra Lifesciences Corp. of Plainsboro, N.J., which indicated that the prohibition against use for uterine fibroids include devices with both general and specific indications in the areas of general surgery, laparoscopy and gynecological surgery. The draft stated that aspirators with a general indication for those three areas of use would feature a contraindication for uterine fibroids, but Integra said it is of the opinion that the agency had intended to apply the document to devices with specific intended uses as well.

Integra further suggested that FDA make clear that the concomitant amending of labels for devices already in distribution would not qualify as a correction, and thus that manufacturers would not be liable for filing a correction report with the agency. The company further requested that the FDA allow device makers to comply with the provisions of the guidance by posting updated versions of the labels on company websites, accompanied by an offer to ship a paper copy of the amended label to end users on request.

No Comments