Category Archives: Digital Health & Medical Devices

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Latest Update on FDA’s Software Pre-Cert Pilot Program

On September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program.  It is the only public update on the program in 2020.  According to the update, FDA will continue to evaluate its Pre-Cert program, which currently is only in pilot form.  Perhaps disappointing … Continue Reading

Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational … Continue Reading

April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies

As reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination systems, … Continue Reading

Upping Hospitals’ Liability Defenses For COVID Measures

This article originally appeared in Law360 on April 13. The Public Readiness and Emergency Preparedness Act, along with the declaration by the U.S. Department of Health and Human Services on countermeasures against COVID-19, provide hospital systems with broad liability protections for measures taken in response to the pandemic.… Continue Reading

Adapting To FDA’s Proposal For Diagnosis Support Software

*This article was originally posted in Law360 on November 4, 2019 With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options.… Continue Reading

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that … Continue Reading

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway.… Continue Reading

Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for artificial intelligence (AI)-based medical devices.  The public docket closed on June 3, 2019, and … Continue Reading
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