Module 16 2024

23/10/2024

US Reporting Requirements

Extensive US reporting requirements ● Domestic and foreign events ● Low causality threshold – “…whenever there is information that reasonably suggests that a device may have caused or contributed to death or serious injury…” ● Per se rule ● U.S. companies and non-U.S. multinationals in same position ● No exemptions ● Historically, exemptions in MEDDEV guidance meant far more events reportable to FDA than in Europe – Protection against a fault functioned correctly (Section 5.1.3.4, EU guidelines) – Serious injury that is an expected side effect and acceptable under risk assessment (Section 5.1.3.5, EU guidelines) ● Now only exemption is for “expected” incidents listed in IFU, subject to MDCG vigilance guidance

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Penalties

Civil penalties for administrative offences

● “Significant” or “knowing” violations or a risk to public health

● FDA can act administratively to fine – US$15,000 for each violation – Up to US$1,000,000 maximum for a single “proceeding” – Consent decrees

● Against

– company – individuals

The Organisation for Professionals in Regulatory Affairs

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