HHS Inspector General Rule Expands Safe Harbors For Beneficiary Remuneration
The final rule protects retailer coupons, free products for the financially needy, and remuneration that clearly promotes access to care.
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AdvaMed wants more safe harbors around product warranties and rebates, while the Healthcare Leadership Council is asking for protections for health records software and manufacturer giveaways.
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.