Lexology November 24, 2023
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This weekly news program, hosted by partner Sam Bernstein, covers recent legal and compliance developments for medical device companies, including enforcement actions, guidance documents, and other legal news.
Episode 17
The HHS Office of Inspector General (OIG) issues an unfavorable advisory opinion regarding the provision of a value-added free hearing aid; the OIG issues comprehensive general compliance program guidance; the FDA issues an FAQ regarding providing scientific information on unapproved uses for cleared/approved medical products; and the U.S. Department of Justice continues its fraud enforcement activities in the durable medical equipment space.
Episode 16
A cardiac imaging company and its founder pay $85.48M and enter into a 5 year CIA to resolve allegations that...
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