In-Vitro Production Radiology Regulation 
XTalks
JUNE 12, 2023
In Medtronic’s annual report, CEO Geoff Martha attributes their success in this area to their comprehensive suite of products and solutions, which equip clinicians with the tools necessary for optimal atrial fibrillation care. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.
FDA Law Blog
DECEMBER 11, 2023
1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.
XTalks
SEPTEMBER 14, 2020
Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.
FDA Law Blog
OCTOBER 10, 2022
The final CDS Guidance represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously considered to be Non-Device CDS or low-risk Device CDS under enforcement discretion. Medical information about a patient.
Expert insights. Personalized for you.
98 
Let's personalize your content