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NEWS & BLOGS
Blog: Blog2


U.S. FDA Initial Importer Service
Updated: 4/15/2024 Introduction Provision Consulting Group ("PCG") ensures compliance with the US Food and Drug Administration ("FDA")...
Provision Consulting Group
Nov 17, 20213 min read


What to Know About Breast Implants
Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery? Those are...
Provision Consulting Group
Nov 17, 20213 min read


How to Study and Market Your Device
How to Study and Market Your Device Medical devices marketed in the United States are subject to the regulatory controls in the Federal...
Provision Consulting Group
Nov 12, 20217 min read


Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of...
Provision Consulting Group
Nov 10, 20212 min read


Coronavirus (COVID-19) Update
The U.S. Food and Drug Administration(FDA) announced the following actions taken in its ongoing response effort to the COVID-19 pandemic...
Provision Consulting Group
Nov 9, 20213 min read


FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and...
Provision Consulting Group
Nov 5, 20212 min read


Allergens in Cosmetics
Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some people. Many...
Provision Consulting Group
Nov 4, 20214 min read


FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
Immediately and thoroughly rinse eyes with gently running water if this occurs What safety concern is FDA announcing? The U.S. Food and...
Provision Consulting Group
Nov 2, 20217 min read


Dental Implants: What You Should Know
Dental implants are medical devices surgically implanted into the jaw to restore a person's ability to chew or their appearance. They...
Provision Consulting Group
Oct 29, 20214 min read


FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years
Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of...
Provision Consulting Group
Oct 29, 20215 min read
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