Enhanced Oversight for Medical Device Safety
New rules allow officials to request medical device documents before or instead of physical inspections. This aims to speed up safety checks, potentially affecting the availability and quality of medical equipment used in hospitals and clinics. Companies will need to provide detailed information about their products.
Key points
Officials can now request documents related to medical devices, like hospital equipment or implants, before conducting a physical inspection.
Requests for documents must include a sufficient description of the records and a rationale for requesting them in advance or in lieu of an inspection.
Within one year, guidelines will be issued detailing when officials will request documents, how to submit them (electronically or physically), and how to evaluate if companies, especially small businesses, provide them within a reasonable timeframe.
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