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Results 1 to 5 of 29



FDA Considers Regulating Refurbishers and Other Third Parties

USA - March 8 2016 The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device…

Co-authors: Sarah H. Stec.


FDA Announces Commitment to MDSAP

USA - January 20 2016 The US Department of Health and Human Services, Food and Drug Administration (FDA) announced on December 17, 2015, that it would participate in the…

Co-authors: Sarah H. Stec.


FDA Issues Draft Guidance on “Emerging Signals”

USA - January 19 2016 On December 31, 2015, FDA announced the availability of the draft guidance document, Public Notification of Emerging Postmarket Medical Device…

Co-authors: Sarah H. Stec.


HHS OIG Opines on Charity Financial Assistance and Kickbacks

USA - January 19 2016 The Department of Health and Human Services (HHS) Office of Inspector General (OIG) posted two similar advisory opinions on January 4, 2016…

Co-authors: Sarah H. Stec.


FDA Announces Commitment to MDSAP

USA - December 22 2015 The FDA announced on December 17 that it would participate in the operational phase of the Medical Device Single Audit Program (MDSAP), starting…

Co-authors: Sarah H. Stec.

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