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NEWS & BLOGS
Blog: Blog2
![[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement](https://static.wixstatic.com/media/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.webp)
![[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement](https://static.wixstatic.com/media/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.webp)
[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA's authority to regulate...
Provision Consulting Group
Sep 18, 20232 min read
![[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend](https://static.wixstatic.com/media/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.webp)
![[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend](https://static.wixstatic.com/media/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.webp)
[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend
The Impact of the FDA's Modernization of Cosmetics Regulation Act (MoCRA) on the Future of the Cosmetics Market The FDA's Modernization...
Provision Consulting Group
Sep 18, 20232 min read
![[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority](https://static.wixstatic.com/media/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_818f2c226c684133a22d63b0971698cc~mv2.webp)
![[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority](https://static.wixstatic.com/media/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_818f2c226c684133a22d63b0971698cc~mv2.webp)
[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority
After 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29,...
Provision Consulting Group
Sep 12, 20232 min read
![[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools](https://static.wixstatic.com/media/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.webp)
![[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools](https://static.wixstatic.com/media/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.webp)
[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools
The U.S. Food and Drug Administration (FDA) is scheduled to hold a webinar on September 12, 2023. This webinar is intended for industry...
Provision Consulting Group
Sep 1, 20231 min read
![[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction](https://static.wixstatic.com/media/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_858b7b33349c4557bd280b84c4732453~mv2.webp)
![[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction](https://static.wixstatic.com/media/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_858b7b33349c4557bd280b84c4732453~mv2.webp)
[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction
After 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29,...
Provision Consulting Group
Aug 14, 20233 min read


FDA, FY 2024 Medical Device User Fees Notice
On July 28, 2023, the U.S. Food and Drug Administration (FDA) announced the Medical Device User Fee for Fiscal Year 2024 (FY 2024). This...
Provision Consulting Group
Jul 31, 20232 min read
![[FDA News] Do Not Use RoyalVibe Health, CellQuicken or ...Ultrasound Medical Devices](https://static.wixstatic.com/media/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.webp)
![[FDA News] Do Not Use RoyalVibe Health, CellQuicken or ...Ultrasound Medical Devices](https://static.wixstatic.com/media/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.webp)
[FDA News] Do Not Use RoyalVibe Health, CellQuicken or ...Ultrasound Medical Devices
On July 17th, the U.S. Food and Drug Administration (FDA) announced a ban on the use of ultrasound medical devices manufactured and...
Provision Consulting Group
Jul 17, 20232 min read
![[FDA News] eMDR System Enhancements](https://static.wixstatic.com/media/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.webp)
![[FDA News] eMDR System Enhancements](https://static.wixstatic.com/media/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.webp)
[FDA News] eMDR System Enhancements
On June 30, 2023, the FDA announced the enhancements to the Electronic Medical Device Reporting (eMDR) system. While the FDA eSubmitter...
Provision Consulting Group
Jul 3, 20232 min read


What are MDR and eMDR?
What is MDR? MDR stands for Medical Device Reporting. It refers to the requirement outlined in 21 CFR Part 803, which mandates...
Provision Consulting Group
Jul 3, 20233 min read
![[FDA Regulatory] De Novo Summaries](https://static.wixstatic.com/media/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.jpg/v1/fill/w_443,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.webp)
![[FDA Regulatory] De Novo Summaries](https://static.wixstatic.com/media/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.webp)
[FDA Regulatory] De Novo Summaries
In the FDA, medical devices are classified into three categories (Class I, II, and III) based on their level of risk. A 510(k) pre-market...
Provision Consulting Group
Jun 26, 20232 min read
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