The Medical Futurist
JUNE 21, 2025
Running trials in animals will take additional engineering and safety tests. How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! What about the smell of the flowers? Without the wind blowing, only 10-20 metres. How about touching or tasting? Globally 1.1
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. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.
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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).
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. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. investigational device as defined in 21 C.F.R. Part 812, the requirements under 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. “I Gibbs , HP&M Director.
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. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.
FDA Law Blog
DECEMBER 15, 2024
In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. In general, a greater understanding and knowledge of the product and manufacturing process can reduce the number of PPQ lots that should be sufficient to qualify the performance of the manufacturing process.
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