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NEWS & BLOGS
Blog: Blog2
![FDA Expands Eligibility for COVID-19 Vaccine Boosters](https://static.wixstatic.com/media/22ea40_2be3cc029ad14e5c90edcb4c531dafe4~mv2.png/v1/fill/w_454,h_256,fp_0.50_0.50,q_95,enc_auto/22ea40_2be3cc029ad14e5c90edcb4c531dafe4~mv2.webp)
Provision Consulting Group
Nov 19, 20214 min read
FDA Expands Eligibility for COVID-19 Vaccine Boosters
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech...
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![U.S. FDA Initial Importer Service](https://static.wixstatic.com/media/22ea40_4bad906ce2174c9c816568c1a7fa57b0~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_4bad906ce2174c9c816568c1a7fa57b0~mv2.webp)
Provision Consulting Group
Nov 17, 20213 min read
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")...
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![What to Know About Breast Implants](https://static.wixstatic.com/media/22ea40_ae0a6d9e158e4d2ea48a958cd11ddf50~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_ae0a6d9e158e4d2ea48a958cd11ddf50~mv2.webp)
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...
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![](https://static.wixstatic.com/media/22ea40_a97c38279a054a3593874598fe2b5977~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/22ea40_a97c38279a054a3593874598fe2b5977~mv2.webp)
![How to Study and Market Your Device](https://static.wixstatic.com/media/22ea40_a97c38279a054a3593874598fe2b5977~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_a97c38279a054a3593874598fe2b5977~mv2.webp)
Provision Consulting Group
Nov 12, 20217 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...
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![Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results](https://static.wixstatic.com/media/22ea40_8d2586adbeeb44d596be7d18f22d727b~mv2.png/v1/fill/w_454,h_256,fp_0.50_0.50,q_95,enc_auto/22ea40_8d2586adbeeb44d596be7d18f22d727b~mv2.webp)
Provision Consulting Group
Nov 10, 20212 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...
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![](https://static.wixstatic.com/media/22ea40_9dbb8217206d41abb8ac9f347749438f~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/22ea40_9dbb8217206d41abb8ac9f347749438f~mv2.webp)
![Coronavirus (COVID-19) Update](https://static.wixstatic.com/media/22ea40_9dbb8217206d41abb8ac9f347749438f~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_9dbb8217206d41abb8ac9f347749438f~mv2.webp)
Provision Consulting Group
Nov 9, 20213 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...
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![](https://static.wixstatic.com/media/22ea40_41754b528eca42fe98930a430908c4ce~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/22ea40_41754b528eca42fe98930a430908c4ce~mv2.webp)
![FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions](https://static.wixstatic.com/media/22ea40_41754b528eca42fe98930a430908c4ce~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_41754b528eca42fe98930a430908c4ce~mv2.webp)
Provision Consulting Group
Nov 5, 20212 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...
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![](https://static.wixstatic.com/media/22ea40_ddb82586a43745128bafdf7aafc8fc3d~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/22ea40_ddb82586a43745128bafdf7aafc8fc3d~mv2.webp)
![Allergens in Cosmetics](https://static.wixstatic.com/media/22ea40_ddb82586a43745128bafdf7aafc8fc3d~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_ddb82586a43745128bafdf7aafc8fc3d~mv2.webp)
Provision Consulting Group
Nov 4, 20214 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...
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![](https://static.wixstatic.com/media/22ea40_7f121a729c914dd7a10007991769eb78~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/22ea40_7f121a729c914dd7a10007991769eb78~mv2.webp)
![FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury](https://static.wixstatic.com/media/22ea40_7f121a729c914dd7a10007991769eb78~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_7f121a729c914dd7a10007991769eb78~mv2.webp)
Provision Consulting Group
Nov 2, 20217 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...
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![](https://static.wixstatic.com/media/22ea40_ff7275087330447b97e3be69e2a2d06a~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/22ea40_ff7275087330447b97e3be69e2a2d06a~mv2.webp)
![Dental Implants: What You Should Know](https://static.wixstatic.com/media/22ea40_ff7275087330447b97e3be69e2a2d06a~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_ff7275087330447b97e3be69e2a2d06a~mv2.webp)
Provision Consulting Group
Oct 29, 20214 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...
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