Lorell B.H.,FDA and Life science Practice Group |
Forrest P.F.,Harvard University
Medical Device and Diagnostic Industry | Year: 2011
The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. At least four factors affect the effectiveness checks process. They are depth of the recall, consignee list, recall communications and the questionnaire for reporting by the recipient; and public warning. Three key strategies are available to device manufacturers for implementing and enhancing effectiveness checks. First is initiating the effectiveness checks process, direct audits of consignees, and verification of the process. If the effectiveness checks process determines that instructions are not being followed regarding the management of the product in violation, the manufacturer must immediately take necessary steps to make the recall effective. The verification process during effectiveness checks should also determine whether the consignee is aware of any injuries, illness, or complaints.
Lundy S.H.,Office of King and Spalding |
Lundy S.H.,FDA and Life science Practice Group |
Bohnenkamp B.A.,FDA and Life science Practice Group |
Patel A.P.,FDA and Life science Practice Group
Medical Device and Diagnostic Industry | Year: 2010
More state legislatures are tightening restrictions on the promotional activities of medical device companies. This expanded regulation is due in part to recent enforcement actions taken against medical device manufacturers by the United States Department of Health and Human Services Office of Inspector General (HHS OIG) for violations of fraud and abuse laws. Currently, four states, California, Nevada, Massachusetts, and Vermont have compliance laws regulating the activities of medical device companies. Massachusetts and Vermont are the first jurisdictions to mandate that device manufacturers disclose to state agencies payments furnished to state-licensed healthcare practitioners. The Nevada Compliance Program Law permits medical device manufacturers to adopt the AdvaMed Code without modification to fulfill the requirement that a company adopt a marketing code of conduct. New Jersey is contemplating provisions that would require physicians to publicly disclose their financial relationships with device manufacturers.