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NEWS & BLOGS
Blog: Blog2
Navigating Medical Device Classification: A Roadmap for Manufacturers
Ever dreamt of bringing your innovative medical device to market? Buckle up, because understanding FDA classification is your first...
Provision Consulting Group
Apr 30, 20242 min read
![[FDA News] FDA Announces Center for Clinical Trial Innovation (C3TI) to Streamline Drug Development](https://static.wixstatic.com/media/7ffba2_91183e2c890d4c0ca7ca0bac3fb16236~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_91183e2c890d4c0ca7ca0bac3fb16236~mv2.jpg)
![[FDA News] FDA Announces Center for Clinical Trial Innovation (C3TI) to Streamline Drug Development](https://static.wixstatic.com/media/7ffba2_91183e2c890d4c0ca7ca0bac3fb16236~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_91183e2c890d4c0ca7ca0bac3fb16236~mv2.jpg)
[FDA News] FDA Announces Center for Clinical Trial Innovation (C3TI) to Streamline Drug Development
Date: 4/29/2024 The Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) recently announced a significant...
Provision Consulting Group
Apr 29, 20242 min read
Understanding 510(k), De Novo, and PMA for Medical Device FDA Compliance
Navigating the FDA’s regulatory pathways for medical devices is critical for manufacturers aiming to enter the U.S. market. The FDA...
Provision Consulting Group
Apr 26, 20242 min read
![[Provision's Latest Update News] Provision Consulting Group Launches Customized Support Program for U.S. Startups! Incorporates AI Technology! Ensure FDA Compliance, Don't Navigate Alone!](https://static.wixstatic.com/media/7ffba2_003307c681a643a995d8b05287acc264~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_003307c681a643a995d8b05287acc264~mv2.jpg)
![[Provision's Latest Update News] Provision Consulting Group Launches Customized Support Program for U.S. Startups! Incorporates AI Technology! Ensure FDA Compliance, Don't Navigate Alone!](https://static.wixstatic.com/media/7ffba2_003307c681a643a995d8b05287acc264~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_003307c681a643a995d8b05287acc264~mv2.jpg)
[Provision's Latest Update News] Provision Consulting Group Launches Customized Support Program for U.S. Startups! Incorporates AI Technology! Ensure FDA Compliance, Don't Navigate Alone!
Date: 4/23/2024 Here's the recent update from Provision Consulting Group regarding MoCRA compliance. As the deadline for FDA MoCRA...
Provision Consulting Group
Apr 25, 20242 min read
510(k) vs. PMA for Medical Device FDA Compliance
Date: 4/25/2024 The path to market for medical devices can be complex, with two primary pathways: the 510(k) premarket notification and...
Provision Consulting Group
Apr 25, 20242 min read
![[FDA News] CDRH Issues 2024 Safety and Innovation Reports](https://static.wixstatic.com/media/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png/v1/fill/w_940,h_530,fp_0.50_0.50,q_35,blur_30,enc_avif,quality_auto/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png)
![[FDA News] CDRH Issues 2024 Safety and Innovation Reports](https://static.wixstatic.com/media/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png/v1/fill/w_940,h_530,fp_0.50_0.50,q_95,enc_avif,quality_auto/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png)
[FDA News] CDRH Issues 2024 Safety and Innovation Reports
Date: 4/22/2023 On April 17, 2024, the FDA released two reports detailing its progress on advancing medical device safety and innovation....
Provision Consulting Group
Apr 22, 20241 min read
MoCRA: More Than Just Compliance, A Boost for the Cosmetics Industry
Date: 4/19/2024 The Modernization of Cosmetics Regulation Act (MoCRA) of 2022, implemented in December 2022, marks a significant shift in...
Provision Consulting Group
Apr 19, 20242 min read
Demystifying the FDA Initial Importer: A Key Role in Medical Device FDA Compliance
Read this, and you will understand the Food and Drug Administration's (FDA) Initial Importer for medical device stakeholders.
Provision Consulting Group
Apr 10, 20243 min read
FDA MoCRA Deadline is approaching - Make sure your cosmetic products meet the requirements - Start signing up now!
Date: 4/2/2024 Register your facility with the FDA by July 1, 2024 The Modernization of Cosmetics Regulation Act 2022 (MoCRA) extends the...
Provision Consulting Group
Apr 2, 20242 min read
![[FDA News] New Announcement: You Can Now Opt to Use eSTAR for 513(g) Information Requests](https://static.wixstatic.com/media/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg)
![[FDA News] New Announcement: You Can Now Opt to Use eSTAR for 513(g) Information Requests](https://static.wixstatic.com/media/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg)
[FDA News] New Announcement: You Can Now Opt to Use eSTAR for 513(g) Information Requests
Date: 4/1/2024 Great news! Starting March 29, 2024, you can choose to use eSTAR for your 513(g) requests for information to CDRH. But...
Provision Consulting Group
Apr 1, 20242 min read
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