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NEWS & BLOGS
Blog: Blog2
![[FDA News] Easing the Burden for Small Medical Device Businesses! - FDA's draft guidance document](https://static.wixstatic.com/media/ea2ded871fb834580ae155324f58345d.jpg/v1/fill/w_1280,h_722,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/ea2ded871fb834580ae155324f58345d.jpg)
![[FDA News] Easing the Burden for Small Medical Device Businesses! - FDA's draft guidance document](https://static.wixstatic.com/media/ea2ded871fb834580ae155324f58345d.jpg/v1/fill/w_1280,h_722,fp_0.50_0.50,q_90,enc_avif,quality_auto/ea2ded871fb834580ae155324f58345d.jpg)
[FDA News] Easing the Burden for Small Medical Device Businesses! - FDA's draft guidance document
Date: 2/21/2024 Guess what? The FDA just dropped some exciting news for small medical device businesses! They've released a draft...
Provision Consulting Group
Feb 21, 20242 min read
![[FDA News] FDA Approves First Medication to Treat Severe Frostbite](https://static.wixstatic.com/media/7ffba2_130efa122e8f4da19126469fdd7e8c54~mv2.jpg/v1/fill/w_1018,h_574,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_130efa122e8f4da19126469fdd7e8c54~mv2.jpg)
![[FDA News] FDA Approves First Medication to Treat Severe Frostbite](https://static.wixstatic.com/media/7ffba2_130efa122e8f4da19126469fdd7e8c54~mv2.jpg/v1/fill/w_1018,h_574,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_130efa122e8f4da19126469fdd7e8c54~mv2.jpg)
[FDA News] FDA Approves First Medication to Treat Severe Frostbite
Date: 2/14/2024 Frostbite is a severe condition that can lead to amputation of the affected fingers or toes. However, there is now new...
Provision Consulting Group
Feb 14, 20242 min read
![[FDA News] FDA Assembles Meeting to Address Concerns Over Pulse Oximeters' Accuracy in Darker-Skinned Individuals](https://static.wixstatic.com/media/7ffba2_01d94a3c4635441981ec0cedd546861e~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_01d94a3c4635441981ec0cedd546861e~mv2.jpg)
![[FDA News] FDA Assembles Meeting to Address Concerns Over Pulse Oximeters' Accuracy in Darker-Skinned Individuals](https://static.wixstatic.com/media/7ffba2_01d94a3c4635441981ec0cedd546861e~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_01d94a3c4635441981ec0cedd546861e~mv2.jpg)
[FDA News] FDA Assembles Meeting to Address Concerns Over Pulse Oximeters' Accuracy in Darker-Skinned Individuals
Date: 2/12/2024 The Food and Drug Administration (FDA) recently convened a meeting to address growing concerns surrounding the accuracy...
Provision Consulting Group
Feb 12, 20242 min read
![[FDA News] The FDA has identified a single cinnamon processor as the likely source of lead contamination in the recalled applesauce pouches](https://static.wixstatic.com/media/7ffba2_ea7dae0862c045bbaf320b485c641922~mv2.png/v1/fill/w_743,h_419,fp_0.50_0.50,lg_1,q_35,blur_30,enc_avif,quality_auto/7ffba2_ea7dae0862c045bbaf320b485c641922~mv2.png)
![[FDA News] The FDA has identified a single cinnamon processor as the likely source of lead contamination in the recalled applesauce pouches](https://static.wixstatic.com/media/7ffba2_ea7dae0862c045bbaf320b485c641922~mv2.png/v1/fill/w_743,h_419,fp_0.50_0.50,lg_1,q_95,enc_avif,quality_auto/7ffba2_ea7dae0862c045bbaf320b485c641922~mv2.png)
[FDA News] The FDA has identified a single cinnamon processor as the likely source of lead contamination in the recalled applesauce pouches
Date: 2/7/2024 The FDA revealed on Tuesday that WanaBana's recalled cinnamon applesauce pouches, linked to lead poisoning cases in the...
Provision Consulting Group
Feb 7, 20242 min read
![[FDA News] Women and Heart Health - Heart Health Champions](https://static.wixstatic.com/media/7ffba2_a5989a46a778473f9fbc07ba7d6d91b5~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_a5989a46a778473f9fbc07ba7d6d91b5~mv2.jpg)
![[FDA News] Women and Heart Health - Heart Health Champions](https://static.wixstatic.com/media/7ffba2_a5989a46a778473f9fbc07ba7d6d91b5~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_a5989a46a778473f9fbc07ba7d6d91b5~mv2.jpg)
[FDA News] Women and Heart Health - Heart Health Champions
Date: 2/5/2024 As we observe National Wear Red Day on the first Friday of February, it's an opportune moment to acknowledge the gravity...
Provision Consulting Group
Feb 5, 20242 min read
![[FDA News] FDA Warns about Another "Fake" Set of Eye Drop Products](https://static.wixstatic.com/media/7ffba2_f2cad9a7c286421c99e3c37562bdd319~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_f2cad9a7c286421c99e3c37562bdd319~mv2.jpg)
![[FDA News] FDA Warns about Another "Fake" Set of Eye Drop Products](https://static.wixstatic.com/media/7ffba2_f2cad9a7c286421c99e3c37562bdd319~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_f2cad9a7c286421c99e3c37562bdd319~mv2.jpg)
[FDA News] FDA Warns about Another "Fake" Set of Eye Drop Products
Updated: 2/2/2024 FDA Warns about Another "Fake" Set of Eye Drop Products - ㅅoday (January 31, 3024) the FDA is warning people about fake...
Provision Consulting Group
Feb 2, 20241 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_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg)
![[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_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg)
[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 NEWS] The FDA has revised the ultimate guidance on the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.](https://static.wixstatic.com/media/7ffba2_a71b997d59ae4093bdd3d61e88cd057d~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_a71b997d59ae4093bdd3d61e88cd057d~mv2.jpg)
![[FDA NEWS] The FDA has revised the ultimate guidance on the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.](https://static.wixstatic.com/media/7ffba2_a71b997d59ae4093bdd3d61e88cd057d~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_a71b997d59ae4093bdd3d61e88cd057d~mv2.jpg)
[FDA NEWS] The FDA has revised the ultimate guidance on the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Date: 1/22/2024 Introduction: In a recent development, the US Food and Drug Administration (FDA) has unveiled a comprehensive set of...
Provision Consulting Group
Jan 22, 20242 min read
12 Common Mistakes to Avoid in a 510(k) Submission
Date: 1/18/2024 The FDA 510(k) submission reviews new medical devices in two main steps: 1. Acceptance Review (15 days): They check if...
Provision Consulting Group
Jan 18, 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
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