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Device Week, 20 December 2019 – Device Tax Repeal, US FDA Funds, LAB Act And More In Latest Budget
In this edition of Device Week, Medtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey discuss a new spending bill approved by the US House and Senate that repeals the medical device excise tax, adds new funds for the US FDA and passes the LAB Act.
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The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.
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Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
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Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.