[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance
In the cosmetics industry, staying updated on regulations is crucial, especially with the recent historical changes due to MoCRA....
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[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...
![[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_341,fp_0.50_0.50,q_90,enc_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...
![[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_341,fp_0.50_0.50,q_90,enc_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,...
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[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...
![[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction](https://static.wixstatic.com/media/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_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,...
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...
![[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_341,fp_0.50_0.50,q_90,enc_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...
![[FDA News] eMDR System Enhancements](https://static.wixstatic.com/media/22ea40_ffce44ffceab4b1c8b55fab308e46b93~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_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...
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...
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[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...
![[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_454,h_341,fp_0.50_0.50,q_90,enc_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...
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[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...
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...
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...
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...
Modernization of Cosmetics Regulation Act of 2022 (MOCRA)
On March 27, 2023, the FDA update announced that has stopped accepting submissions to the Voluntary Cosmetic Registration Program(VCRP)...
[FDA News] Public Meeting: Good Manufacturing Practices for Cosmetic Products
FDA will have a public meeting for good manufacturing practices for cosmetic products. Please save the date: The U.S. Food and Drug...
FDA has Stopped Voluntary Cosmetic Registration Program(VCRP) to the Mandatory Cosmetic Registration
April 5 2023 On March 27, 2023, the FDA update announced that has stopped accepting submissions to the Voluntary Cosmetic Registration...
FDA Guidance, Clinical Decision Support Software(CDS)
February 22 2023 The US Food and Drug Administration has released final guidance for clinical decision software (CDS) functions,...
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