Areta Kupchyk on Medical Devices

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more

2/8/2024 / CGMP , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , ISOs , Medical Devices , Regulatory Agenda , Regulatory Requirements

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

10/25/2023 / Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Healthcare Reform , Labeling , Medical Devices , Medical Software , Pharmaceutical Industry , Policies and Procedures , Regulatory Requirements , Regulatory Standards

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

10/3/2023 / CDRH , Clinical Laboratory Testing , Comment Period , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Proposed Rules , Regulatory Requirements

FDA Issues Emergency Use Authorizations for Additional Medical Devices in Response to COVID-19

On Friday, April 10, 2020, the Food and Drug Administration (FDA) announced that it has issued two additional Emergency Use Authorizations (EUA) in response to the coronavirus pandemic: one for a device that is used to...more

4/15/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Personal Protective Equipment

Modernization of the 510(k) Pathway to Market Medical Devices

Introduction - Congress enacted the Medical Device Amendments in 1976 establishing the regulatory framework for evaluating safety and effectiveness of medical devices. The U.S. Food and Drug Administration (“FDA” or...more

11/30/2018 / 510(k) RTA , Food and Drug Administration (FDA) , Medical Devices

Areta Kupchyk

Foley Hoag LLP

Popular Topics by This Author

Latest Posts › Medical Devices

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA Issues Emergency Use Authorizations for Additional Medical Devices in Response to COVID-19

Modernization of the 510(k) Pathway to Market Medical Devices

Areta Kupchyk

Foley Hoag LLP

Popular Topics by This Author

Latest Posts › Medical Devices

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA Issues Emergency Use Authorizations for Additional Medical Devices in Response to COVID-19

Modernization of the 510(k) Pathway to Market Medical Devices

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