An ophthalmology medical device distributor loses an Anti-kickback and False Claims Act case and is ordered to pay nearly $490M; the Medical Device Innovation Consortium (MDIC) releases a white paper regarding the #makeCAPAcool framework, which appears to accelerate corrective actions; FDA asks manufacturers to voluntarily notify FDA of manufacturing interruptions and discontinuances despite the end of the Public Health Emergency and asks Congress for the authority to make such notifications obligatory, even in the absence of a See more +

An ophthalmology medical device distributor loses an Anti-kickback and False Claims Act case and is ordered to pay nearly $490M; the Medical Device Innovation Consortium (MDIC) releases a white paper regarding the #makeCAPAcool framework, which appears to accelerate corrective actions; FDA asks manufacturers to voluntarily notify FDA of manufacturing interruptions and discontinuances despite the end of the Public Health Emergency and asks Congress for the authority to make such notifications obligatory, even in the absence of a public health emergency; fraud and abuse concerns regarding excessive sales representative and distributor compensation are discussed in the context of an alleged Foreign Corrupt Practices Act violation and under the Anti-kickback Statute. See less -