Michele Buenafe on Comment Period

FDA Issues Long-Awaited Quality System Regulation Amendments

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a somewhat surprising move, the...more

2/25/2022 / Comment Period , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Proposed Rules , Supply Chain

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

6/15/2016 / Comment Period , Data Collection , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Information Sharing , Manufacturers , Medical Devices , Patient-Specific , Privacy Policy

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

5/25/2016 / Clinical Trials , Comment Period , Draft Guidance , EHR , Food and Drug Administration (FDA) , HITECH Act , ONC

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

5/20/2016 / 3D Printing , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

2/10/2016 / Adverse Events , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

2/3/2016 / Comment Period , Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Risk Management

Michele Buenafe

Morgan Lewis

Popular Topics by This Author

Latest Posts › Comment Period

FDA Issues Long-Awaited Quality System Regulation Amendments

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

FDA Issues Draft Guidance on ‘Emerging Signals’

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

Michele Buenafe

Morgan Lewis

Popular Topics by This Author

Latest Posts › Comment Period

FDA Issues Long-Awaited Quality System Regulation Amendments

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

FDA Issues Draft Guidance on ‘Emerging Signals’

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

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