Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device Reprocessor for Changes to Marketed Products

“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor and distributor of a reprocessed medical device.¹ While the Warning Letter mentioned quality-related concerns, the focus was on the company’s sale of new models of previously cleared 510(k)s, which FDA said required new 510(k)s. This Bulletin summarizes the issues involved and our observations.

Highlights

• FDA inspected the company and issued a Form FDA 483 List of Inspectional Observations, noting non-compliance with Quality System regulations and marketing new, unapproved devices.
• The company responded and, based on the Warning Letter, addressed the quality-related concerns. However, the agency wrote that the reprocessor added new models of previously cleared 510(k)s that were not cleared or approved.
• Without FDA authorization, the agency noted that the medical devices were “adulterated” (i.e., lacked approval of a premarket approval application) and “misbranded” (i.e., lacked a cleared 510(k)).
• According to the Warning Letter, FDA acknowledged that the company had prepared a Letter to File, justifying its decision not to submit new 510(k)s for the new models. However, FDA noted the types of changes made and why it believed new marketing applications were required. For example:

These new models . . . are . . . versions of OEM models that were not included in [the cleared 510(k)]. The additional OEM models have smaller diameter shafts, smaller diameters lumens, smaller tip elements, and/or longer shafts than the OEM models included in [the 510(k) number], and they present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in [the 510(k) number]. Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability of your new . . . models.² These changes could significantly affect the safety or effectiveness of the . . . devices and required the submission of a new 510(k).

• FDA provided the same scrutiny for several of the company’s products.

AGG Observations

• The 510(k) issue arose due to an FDA inspection, not a trade complaint (or, at least, this is not noted in the Warning Letter). The agency learns of non-compliant marketing activities in a number of ways.
• The company prepared Letters to File for its decision. Letters to File help minimize risk; they do not eliminate risk. FDA disagreed with the assessments. This is why we often note that it’s good to be FDA, as FDA gets the final say.
• FDA identified specific changes to the previously cleared 510(k) that raised concerns: “These changes could significantly affect the safety of effectiveness” of the devices. Safety and effectiveness (and intended use) remain the standards to review when evaluating changes to already cleared devices.
• Resolution of a certain set of problems (here, quality issues) does not necessarily inoculate the company from risk exposure if there are other problems (here, lack of a 510(k)). Non-compliance is non-compliance, no matter what specific violation has occurred.
• Every little one (change), every little one (potential violation) can add up to a big one (enforcement).

[1] The Warning Letter is available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/renovo-inc-dba-provision-device-reprocessing-solutions-664014-10132023.

[2] See FDA’s Guidance for Industry and Food and Drug Administration Staff on Deciding When to Submit a 510(k) for a Change to an Existing Device available at https://www.fda.gov/media/99812/download.