Jonathan Kahan

Jonathan Kahan

Hogan Lovells

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FDA resumes enforcement relating to laboratory developed tests

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in one of the first FDA enforcement...more

4/12/2019  /  Clinical Laboratories , Enforcement Actions , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry , Regulatory Standards , Warning Letters

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

5/7/2018  /  21st Century Cures Act , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Patient Safety , Pharmaceutical Industry , Policy Statement , Regulatory Oversight , Regulatory Standards , Risk Management

FDA releases working model for Software Precertification Pilot Program

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more

5/4/2018  /  Comment Period , Food and Drug Administration (FDA) , Medical Devices , PreCert Pilot Program , Regulatory Oversight , Regulatory Standards , Software

FDA’s Software Pre-Cert Program: More Details Revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

8/10/2017  /  21st Century Cures Initiative , Digital Health , FDA Approval , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Medical Software , Regulatory Standards

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

1/19/2017  /  Final Rules , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Off-Label Use , Pharmaceutical Industry , Prescription Drugs , Regulatory Standards
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