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NEWS & BLOGS
Blog: Blog2
Empowering Succes: 510(k) Testing Request, Rapid Response through Collaboration with Provision
Date: 11/24/2023 FDA Testing Supplementary Request, Rapid Response through Effective Collaboration with a Prominent Dental Company and...
Provision Consulting Group
Nov 24, 20233 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
K-Beauty Expo Keynote: FDA Cosmetic Law MoCRA Compliance Insights from PCG Expertise
Date: 11/17/2023 At the K Beauty Expo hosted by KINTEX on October 13th, Provision Consulting Group's co-CEO, Sung Kwon, served as a...
Provision Consulting Group
Nov 17, 20232 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 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 News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance](https://static.wixstatic.com/media/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg/v1/fill/w_1000,h_564,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg)
![[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_1000,h_564,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg)
[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
![[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.](https://static.wixstatic.com/media/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg)
![[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.](https://static.wixstatic.com/media/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg)
[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.
On October 2nd, the U.S. Food and Drug Administration (FDA) issued final guidance on the "Electronic Submissions Template for Medical...
Provision Consulting Group
Oct 2, 20231 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_1773,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_1024,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
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