Many of us remember the television commercial where an older woman falls and cries out, “Help! I’ve fallen and I can’t get up.” This image and quote came to our mind when FDA recently issued a Warning Letter to a medical device company that manufactured and distributed a Femoral Resurfacing Cup and Total Hip System.¹ Among other allegations, FDA noted the company promoted the products outside of its 510(k)-cleared uses.

This Bulletin summarizes the key promotional concerns cited in the Warning Letter (we will not review the quality-related deficiencies). We also add our own observations.

Summary

• The company held 510(k) clearance for pain hip cup arthroplasty, but the product was not to be labeled or promoted for non-cemented use (could claim intended for cemented use only).
• During an inspection, FDA found that there were major changes made to the device, including Instructions for Use that promoted the product as having a coating for cementless fixation, all which could significantly affect the device’s safety or effectiveness.
• The agency wrote that the company marketed the Femoral Resurfacing Cup as a component of the Total Hip System, which was intended for use as a semi-constrained total hip joint replacement device composed of an acetabular fixation cup with a polyethylene bearing surface in combination with a femoral resurfacing cup.
  • FDA classified this type of hip joint replacement device as class III, which required submission and approval of a Premarket Approval Application.
• Further, after FDA notified the company that it had not fulfilled its annual registration and listing obligations, the company told the agency that it would complete its registration and listing. However, the company did not do so, failing to register and list any of its devices with FDA, meaning that all of the devices were then misbranded.

AGG Observations

• Despite losing First Amendment challenges to its enforcement of unlawful promotion, the agency will take action when it believes necessary; risk to the patient will certainly be a catalyst.
• FDA made clear that, while the device was authorized for sale for one use, it was specifically not to be used for another. The company seemingly ignored this previous admonition. Not a good idea.
• The company promoted the 510(k)-cleared product as part of a “total system,” which changed the regulatory classification. Companies must be aware that combining, packaging, or otherwise putting two products or components together may change each’s regulatory classification status.
• The agency learned of the unlawful promotion during an inspection. There is no indication in the Warning Letter that a competitor complained to the company.
• The company did not respond to FDA’s initial concerns within 15 business days of the inspection completion, as it promised. It is bad form and not smart to promise FDA something and then not deliver.
• The Warning Letter, similar to other Warning Letters, was posted on FDA’s website. The safety concerns noted in the Warning Letter will, no doubt, gain the attention of plaintiff lawyers.
• The medical device firm took a serious fall in non-compliance. FDA will be watching to see if the company can get back up into compliance.

[1] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synovo-production-inc-647427-03232023; the authors considered referencing Huey Lewis & The News’ “Hip to be Square,” but thought better of it.