Michele Buenafe on Regulatory Oversight

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

7/7/2025 / Artificial Intelligence , Department of Health and Human Services (HHS) , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Rulemaking Process

Distribution Chain Compliance for Medical Devices

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more

5/5/2025 / Distributors , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Regulatory Oversight , Regulatory Requirements , Retailers , Supply Chain

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

4/22/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Oversight , Regulatory Requirements

How New Executive Orders May Affect FDA’s Medical Device Operations

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

2/3/2025 / Artificial Intelligence , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Policy Updates , Regulatory Oversight , Regulatory Requirements , Trump Administration , World Health Organization

Digital Health Trends to Watch in 2022

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

2/25/2022 / Centers for Medicare & Medicaid Services (CMS) , Cybersecurity , Data Protection , Digital Health , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Health Care Providers , Health Information Technologies , Life Sciences , Medical Devices , Pharmaceutical Industry , Popular , Regulatory Oversight , Telehealth , Telemedicine

HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic

The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more

8/31/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Infectious Diseases , Laboratory Developed Tests , Life Sciences , Policy Statement , Regulatory Oversight

FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more

7/20/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Inspections , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Supply Chain

Michele Buenafe

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