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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Oct 24, 20223 min read
FDA Class 1 Medical Devices : UDI Requirements
October 24 2022 FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database...
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Provision Consulting Group
Oct 21, 20225 min read
FDA UDI Guidance of Legacy Identification Number (NDC/NHRIC)
October 21 2022 FDA has announced the availability of final guidance entitled “Enforcement Policy Regarding Use of National Health...
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Provision Consulting Group
Sep 13, 20223 min read
How Cosmetics are Regulated by FDA?
Sep 13 2022 Under the regulation of the FDA, cosmetic products and ingredients do not need FDA premarket approval, with the exception of...
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Provision Consulting Group
Sep 9, 20223 min read
FDA Medical Device, De Novo Process Guide
Sep 09 2022 The new device which is a low to medium risk on the market requires a pathway of the De Novo process. The De Novo request...
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Provision Consulting Group
Sep 8, 20222 min read
FDA Medical Device, overview of 510(k) guide
Sep 08 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...
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Provision Consulting Group
Sep 1, 20222 min read
FDA Regulatory of Hearing Aids
Sep 01 2022 On August 16, 2022, The U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in...
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Provision Consulting Group
Aug 29, 20223 min read
What are the basic FDA requirements of Unique Device Identification(UDI) System ?
Aug 29 2022 All devices are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted. This...
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Provision Consulting Group
Aug 17, 20222 min read
FDA Medical Device, overview of 510(k) guide
Aug 17 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...
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Provision Consulting Group
Aug 11, 20222 min read
FDA Guidance of OTC Drug
Aug 11 2022 To market OTC Drug products in the U.S, There are two pathways which is submitting a New Drug Application (NDA) for FDA...
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Provision Consulting Group
Aug 10, 20223 min read
FDA Medical Device Q-Submission : Preparation and Review
Aug 10 2022 The Q-Submission Program allows manufacturers of medical devices and in vitro diagnostic devices to obtain feedback on the...
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