Jodi Scott

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FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

7/15/2025 / Food and Drug Administration (FDA) , Manufacturers , Medical Devices , National Security , New Guidance , Records Request , Regulatory Agencies , Supply Chain

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

7/7/2025 / Cybersecurity , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , New Regulations , Regulatory Requirements , Risk Management , Software

FDA clarifies 510(k) clearance transfer rules in new Q&A guidance

The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more

6/9/2025 / Filing Requirements , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Regulation , Regulatory Requirements

FDA issues final guidance for public warnings and notification of recalls

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more

2/26/2019 / Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Pharmaceutical Industry , Prescription Drugs , Product Recalls , Public Notice , Regulatory Oversight

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