Clinic Electronics Information Manufacturing 
FDA Law Blog
FEBRUARY 9, 2024
Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.
FDA Law Blog
DECEMBER 12, 2022
If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop.
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FDA Law Blog
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.
The Medical Futurist
JUNE 21, 2025
Compared to that, our hearing only processes 11 percent of information, while smell 3.5 Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.
FDA Law Blog
DECEMBER 6, 2024
The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.
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