FDA Regulations 5/11

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[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 Regulations

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...

FDA Regulations

Provision Consulting Group

Jul 31, 20232 min read

[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 Regulations

Provision Consulting Group

Jul 17, 20232 min read

[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...

FDA Regulations

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...

FDA Regulations

Provision Consulting Group

Jul 3, 20233 min read

[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 Regulations

Provision Consulting Group

Jun 26, 20232 min read

[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...

FDA Regulations

Provision Consulting Group

Jun 14, 20232 min read

[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...

FDA Regulations

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...

FDA Regulations

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...

FDA Regulations

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...

FDA Regulations

Provision Consulting Group

Apr 26, 20231 min read

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 Regulations

Provision Consulting Group

Apr 19, 20232 min read

[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 Regulations

Provision Consulting Group

Apr 19, 20231 min read

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 Regulations

Provision Consulting Group

Apr 5, 20232 min read

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,...

FDA Regulations

Provision Consulting Group

Feb 22, 20232 min read

Product-Specific Guidance Meeting between FDA and ANDA applicants

February 17 2023 On February 17, 2023, FDA published a new draft guidance for industry, “Product-Specific Guidance Meetings Between FDA...

FDA Regulations

Provision Consulting Group

Feb 17, 20232 min read

FDA Regulatory Focus on Compounding Children's Ibuprofen in Response to Increased Demand

February 10 2023 The guidance issued by the Food and Drug Administration (FDA) was released due to an increase in demand for pediatric...

FDA Regulations

Provision Consulting Group

Feb 10, 20232 min read

FDA Compliance Label Review, How vital is it?

Feburary 08 2023 The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed...

FDA Regulations

Provision Consulting Group

Feb 8, 20232 min read

What to know FDA Import Alerts & Import Refusals?

January 27 2023 Import Alerts notifies that a product is subject to detention without physical examination (DWPE) because it violates or...

FDA Regulations

Provision Consulting Group

Jan 27, 20232 min read

FDA New Cosmetics Regulation: MoCRA (Modernization of Cosmetics Regulation Act)

January 25, 2023 On December 29, 2022, The president signed a new law: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA),...

FDA Regulations

Provision Consulting Group

Jan 25, 20232 min read