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NEWS & BLOGS
Blog: Blog2


New FDA Import Rules Eliminate $800 De Minimis Exemption
What the End of the “De Minimis” Rule Means for FDA-Regulated Imports As of July 2025, the U.S. FDA has officially eliminated the...
Provision Consulting Group
Jul 282 min read


Top 5 Cosmetic Labeling Mistakes to Avoid After MoCRA Compliance
5 Common Cosmetic Labeling Mistakes Revealed by FDA Warning Letters As K-Beauty continues its surge in popularity in the U.S. cosmetic...
Provision Consulting Group
Jul 233 min read


2025 FDA Compliance Essentials for K-Beauty Brands
November 4, 2024 Introduction As K-beauty brands continue to gain popularity in the U.S., navigating FDA regulations is crucial for...
Provision Consulting Group
Nov 4, 20243 min read


FDA Issues New 2024 Tattoo Ink Safety Guidelines: What Tattoo Artists and Consumers Need to Know
October 30, 2024 Introduction The tattoo industry has recently received a major update from the U.S. Food and Drug Administration (FDA)...
Provision Consulting Group
Oct 30, 20242 min read


How to Determine Your Product’s FDA Category: Is It a Cosmetic, Dietary Supplement, OTC Drug, or Medical Device?
October 18, 2024 When bringing a product to market, one of the most important steps is figuring out how the FDA categorizes your product...
Provision Consulting Group
Oct 18, 20244 min read


The K-Beauty Ingredients Catching the Eye of the U.S. FDA: An Opportunity to Prove Their Unique Potential to the World.
October 02, 2024 K-beauty is renowned for its use of innovative and unique ingredients like snail mucin, ginseng, and centella asiatica,...
Provision Consulting Group
Oct 2, 20243 min read


Navigating FDA Regulations: What K-Beauty Brands Need to Know to Enter the U.S. Market
September 27, 2024 The global rise of K-beauty is undeniable, with its innovative products and unique skincare routines taking over...
Provision Consulting Group
Sep 27, 20243 min read


K-Beauty Sunscreens and the FDA: How Regulatory Differences Affect U.S. Consumers
September 30, 2024 K-beauty sunscreens have gained massive popularity in recent years, often praised for their lightweight formulations...
Provision Consulting Group
Sep 27, 20243 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_416,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.webp)
![[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_454,h_273,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.webp)
[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


Unveiling the Dynamics in the Cosmetics Industry Extended MoCRA Implementation and Registration
Date: 12/13/2023 The Dynamics of the Cosmetics Industry in Response to the Extension of MoCRA Facility and Product Registration Deadlines...
Provision Consulting Group
Dec 13, 20233 min read


Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision Consulting Group
Date: 12/11/2023 Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision...
Provision Consulting Group
Dec 11, 20232 min read


Essential Cosmetic Testing for Entry into the U.S. Market
Date: 12/6/2023 In the glamorous world of beauty and skincare, cosmetics play a pivotal role, gracing our skin with radiance. However,...
Provision Consulting Group
Dec 6, 20232 min read


Charting Corporate Success: Attaining Asia's Premier 510(k) Certification with Provision
Date: 11/27/2023 Empowering Women's Health Globally: Provision Consulting Group's Vital Role A pioneering force in women's products, our...
Provision Consulting Group
Nov 27, 20232 min read


FDA Warning Letter: Regulatory Concerns for Eye Health Products on Amazon.com
Date: 11/22/2023 In the realm of regulatory scrutiny, our attention is drawn to a recent development where Amazon is a central figure—the...
Provision Consulting Group
Nov 22, 20232 min read


FDA Compliance & Amazon Success: Our Case Study in Rapid Regulatory Remediation
Date: 11/21/2023 Ensuring FDA Compliance and Resuming Sales: Provision Consulting Group's Expertise in Action in Amazon. Operating under...
Provision Consulting Group
Nov 21, 20232 min read


Acquisition of 510(k) Certification: Ensuring Optimal Efficiency - Dental Implant Excellence
Date: 11/17/2023 Supported by the expertise of Provision Consulting Group, a leading global dental implant enterprise swiftly secured...
Provision Consulting Group
Nov 17, 20231 min read


Raphas, a Leading Microneedle Patch Manufacturer in South Korea, Achieves Outstanding FDA cGMP Inspection Results Through Collaboration with Provision Consulting Group
Date: 11/3/2023 Raphas, a leading innovator in microneedle patch technology, develops and applies its products across a wide range of...
Provision Consulting Group
Nov 10, 20232 min read
![[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance](https://static.wixstatic.com/media/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg/v1/fill/w_375,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.webp)
![[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance](https://static.wixstatic.com/media/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg/v1/fill/w_454,h_303,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.webp)
[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance
The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidance Use of...
Provision Consulting Group
Oct 6, 20231 min read


Provision Consulting Group traveled for FDA GMP/QMS Mock audit in South Korea
In March, 2023, Mr. Kwon, one of the Co-CEOs of Provision Consulting Group, traveled to South Korea to provide consulting services and...
Provision Consulting Group
Apr 13, 20231 min read
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