The Medical Futurist
JUNE 21, 2025
Running trials in animals will take additional engineering and safety tests. In February 2017, experts at the Center for Genome Engineering, within the Institute for Basic Science (IBS) reported the use of CRISPR in performing “gene surgery” in the layer of tissue that supports the retina of living mice.
FDA Law Blog
JANUARY 4, 2023
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
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FDA Law Blog
FEBRUARY 7, 2023
For PMA devices, the marketing application contains quality system and manufacturing information, so getting started on the quality system in parallel to device development is important for a timely submission. A question that often comes up is: when is the best time to start preparing for post-market requirements? Design controls (21 C.F.R.
FDA Law Blog
FEBRUARY 19, 2024
Prior to entering the legal field, she served as a biomedical/electrical engineer at an engineering firm involved in the design and development of radio frequency (RF) distribution systems from initial market and data preparation through testing and troubleshooting of these products. Gibbs , HP&M Director.
FDA Law Blog
FEBRUARY 9, 2024
Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. Whereas if the DHT meets the device definition and is used outside of a clinical investigation, full compliance with design controls requirements is applicable.
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.
FDA Law Blog
DECEMBER 8, 2022
labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., Other technical labeling matters. 1, 2023, sesame.
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