FDA’s Center for Devices and Radiological Health published its Medical Device Recall Report for the last decade. The number of recalls almost doubled, approximating the increase in device spending over the same period of time. However, the report attributes the bulk of the increase to two factors: FDA’s public meeting on radiological safety, and FDA investigators increasingly citing firms for reporting violations. The report stated that “over half of the increase in recalls since 2003 can be attributed to the recalls reported by establishments that were observed to have 21 CFR 806 reporting issues.” In addition, almost all of those firms were also cited for Quality System observations.
These firms are not “reporting” corrections and removals, as defined by that regulation, unless the FDA investigator observes a violation during an inspection. There might be the odd manufacturer or importer who, to their own and the public’s peril, ignores a quality problem or does not commit the resources to promptly address it. However, probably most of these observations are firms that apply due diligence but come to an incorrect conclusion about reporting the recall. Some confusion arises over the understanding of the definitions of correction and removal. A recall does not always involve taking the device back. In other cases, firms may remove a device but do not believe that their action meets the definition of a recall or a correction or removal and do not contact their local District Office. The Center usually interprets those situations more strictly. A Warning Letter almost always follows, particularly when combined with those Quality System violations.
A second look is wise. Sometimes an “outside” pair of eyes could help avoid the issue altogether. FDAImports.com’s experienced personnel can provide that second opinion. Contact us today to find out how we can help your business.
