2015 Manufacturing Medical Provider 
The Medical Futurist
JUNE 17, 2025
Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. Can you imagine that you might get your 3D-printed prosthesis in an hour instead of 4-5 sessions at the dentist?
The Medical Futurist
JUNE 21, 2025
In 2015, surgeons in Manchester, UK have performed the first bionic eye implant for an AMD patient using Second Sight’s innovation. 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. That must have been truly amazing!
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FDA Law Blog
AUGUST 15, 2021
Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. Thus ends a saga that began with a proposal in 2015 to amend the “intended use” regulation. label use if the manufacturer knew about it. By Jeffrey K. The proposal to delete this provision made sense , because the off?label
FDA Law Blog
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
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.
FDA Law Blog
SEPTEMBER 26, 2024
Newberger — We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. Manufacturers can expect increased interaction with the review team and prioritized review of the marketing submission.” By Jennifer D.
FDA Law Blog
APRIL 11, 2022
Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. This estimation of risk is important because it drives both decision making and regulatory compliance.
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