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NEWS & BLOGS
Blog: Blog2
How the FDA Regulates Artificial Intelligence (AI) in Healthcare Devices
September 25, 2024 Artificial intelligence (AI) is revolutionizing the healthcare industry, driving innovations in diagnostics, patient...
Provision Consulting Group
Sep 25, 20244 min read
Breaking Down the Latest FDA Guidance on Over-the-Counter Drug Labeling
September 24, 2024 As the over-the-counter (OTC) drug market continues to grow, staying updated with FDA guidelines is crucial for both...
Provision Consulting Group
Sep 24, 20244 min read
Navigating FDA Regulations for Dietary Supplements
The dietary supplement industry has seen remarkable growth in recent years, driven by increased consumer awareness and demand for health...
Provision Consulting Group
Sep 23, 20243 min read
510(k) vs. PMA for Medical Device FDA Compliance
Date: 4/25/2024 The path to market for medical devices can be complex, with two primary pathways: the 510(k) premarket notification and...
Provision Consulting Group
Apr 25, 20242 min read
![[FDA Regulation] Get Ready for the New FDA Medical Device CGMP Rule: A Glimpse of Final Rule](https://static.wixstatic.com/media/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg/v1/fill/w_1663,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg)
![[FDA Regulation] Get Ready for the New FDA Medical Device CGMP Rule: A Glimpse of Final Rule](https://static.wixstatic.com/media/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg/v1/fill/w_1816,h_1092,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg)
[FDA Regulation] Get Ready for the New FDA Medical Device CGMP Rule: A Glimpse of Final Rule
Date: 1/31/2024 The Food and Drug Administration (FDA) has announced the issuance of a device final rule aimed at amending the current...
Provision Consulting Group
Jan 31, 20242 min read
FDA’s MoCRA Cosmetics Portal is Open: A Game-Changer for Industry Compliance
Date: 12/19/2023 FDA’s MoCRA Cosmetics Portal is Open! Cosmetics Constituent Update: December 18, 2023 In a significant move, the U.S....
Provision Consulting Group
Dec 19, 20232 min read
FDA Postpones Cosmetic Facility Registration Enforcement: Navigating MoCRA Compliance Landscape
Date: 11/10/2023 In a recent announcement on November 8, 2023, the FDA communicated a deferment in the enforcement date for cosmetic...
Provision Consulting Group
Nov 10, 20233 min read
![[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance](https://static.wixstatic.com/media/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg/v1/fill/w_1503,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg)
![[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance](https://static.wixstatic.com/media/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg/v1/fill/w_1816,h_1208,fp_0.50_0.50,q_90,enc_avif,quality_auto/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg)
[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance
Date: 12/14/2023 In the cosmetics industry, staying updated on regulations is crucial, especially with the recent historical changes due...
Provision Consulting Group
Sep 22, 20232 min read
![[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement](https://static.wixstatic.com/media/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg/v1/fill/w_1780,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg)
![[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement](https://static.wixstatic.com/media/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg/v1/fill/w_1816,h_1020,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg)
[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_1780,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg)
![[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend](https://static.wixstatic.com/media/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg/v1/fill/w_1816,h_1020,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg)
[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_998,h_563,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg)
![[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority](https://static.wixstatic.com/media/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg/v1/fill/w_998,h_563,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg)
[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_999,h_667,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg)
![[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools](https://static.wixstatic.com/media/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg/v1/fill/w_999,h_667,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg)
[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_1202,h_895,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg)
![[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction](https://static.wixstatic.com/media/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg/v1/fill/w_1202,h_895,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg)
[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_1000,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.jpg)
![[FDA News] Do Not Use RoyalVibe Health, CellQuicken or ...Ultrasound Medical Devices](https://static.wixstatic.com/media/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.jpg/v1/fill/w_1816,h_1816,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_104d7316ccc241979f5cfed9ce2a8205~mv2.jpg)
[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_1700,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.jpg)
![[FDA News] eMDR System Enhancements](https://static.wixstatic.com/media/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.jpg/v1/fill/w_1816,h_1068,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.jpg)
[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_1498,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.jpg)
![[FDA Regulatory] De Novo Summaries](https://static.wixstatic.com/media/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.jpg/v1/fill/w_1816,h_1212,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_9a17cf74882a4dd6bcfd4e7b83f4b973~mv2.jpg)
[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
![[FDA News] Starting October 1, 2023, all 510(k) submissions must be submitted through eSTAR](https://static.wixstatic.com/media/22ea40_e7823c074c8844e3b177345512ad991c~mv2.jpg/v1/fill/w_998,h_563,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_e7823c074c8844e3b177345512ad991c~mv2.jpg)
![[FDA News] Starting October 1, 2023, all 510(k) submissions must be submitted through eSTAR](https://static.wixstatic.com/media/22ea40_e7823c074c8844e3b177345512ad991c~mv2.jpg/v1/fill/w_998,h_563,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_e7823c074c8844e3b177345512ad991c~mv2.jpg)
[FDA News] Starting October 1, 2023, all 510(k) submissions must be submitted through eSTAR
On June 9, 2023, the FDA announced that through eSTAR (The electronic Submission Template and Resource), it is now possible to submit...
Provision Consulting Group
Jun 14, 20232 min read
![[FDA News] Regulatory Education for Industry (REdI) Annual Conference 2023](https://static.wixstatic.com/media/22ea40_74b33632466948ebbe9aabff1fabfd9e~mv2.jpg/v1/fill/w_999,h_667,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_74b33632466948ebbe9aabff1fabfd9e~mv2.jpg)
![[FDA News] Regulatory Education for Industry (REdI) Annual Conference 2023](https://static.wixstatic.com/media/22ea40_74b33632466948ebbe9aabff1fabfd9e~mv2.jpg/v1/fill/w_999,h_667,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_74b33632466948ebbe9aabff1fabfd9e~mv2.jpg)
[FDA News] Regulatory Education for Industry (REdI) Annual Conference 2023
The FDA will be hosting the Regulatory Education for Industry (REdI) Annual Conference 2023 free of charge. Date: June 5(Mon) – June...
Provision Consulting Group
Jun 2, 20231 min read
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