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The Medical Futurist
JUNE 21, 2025
Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. 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? Globally 1.1
FDA Law Blog
FEBRUARY 9, 2024
Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates. By Adrienne R.
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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. There are many resources that provide information and guidance for each of these required elements. Design controls (21 C.F.R.
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 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 Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.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In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. As you review these questions and answers, nothing that CBER provides in this guidance is new. Questions and Answers Guidance (see previous coverage here ).
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. lampreys); Bony fish (e.g., trout); and.
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