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NEWS & BLOGS
Blog: Blog2
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_1773,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_1024,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_1773,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_1024,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_1773,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_1024,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_1000,h_564,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_1000,h_564,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
The difference between FDA Registered, FDA Cleared, and FDA Approved
When examining advertisements for medical devices, it is common to come across the phrase "FDA approved" to enhance the credibility and...
Provision Consulting Group
May 31, 20232 min read
How Should Cosmetics Companies Prepare for MoCRA?
Updated on 9/7/23. On December 29, 2022, the FDA enacted "The Modernization of Cosmetics Regulation Act (MOCRA)." The critical of the...
Provision Consulting Group
May 24, 20232 min read
FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
The FDA approved a treatment for individuals who have amyotrophic lateral sclerosis (ALS) and carry a specific genetic mutation known as...
Provision Consulting Group
Apr 26, 20231 min read
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