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NEWS & BLOGS
Blog: Blog2
An Overview of 510(k) Electronic Submission Guidance for FDA 510(k) Submissions
Nov 11 2022 On October 3, 2022 the FDA announced that sending electronic copy (eCopy) or electronic Submission Template And Resource...
Provision Consulting Group
Nov 11, 20222 min read
Reminder: FDA New Medical Device User Fees for FY 2023
Nov 07 2022 On October 5th, 2022, the FDA has announced the Fiscal Year (FY) 2023 fees under the MDUFA (Medical Device User Fee...
Provision Consulting Group
Nov 7, 20222 min read
FDA Guidance for Medical Device Data Systems, MedicalImage Storage Devices, and Medical Image Device
October 28 2022 The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better,...
Provision Consulting Group
Oct 28, 20225 min read
Overview of Premarket Approval PMA
October 25 2022 Who can submit a PMA? The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to...
Provision Consulting Group
Oct 25, 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...
Provision Consulting Group
Oct 24, 20223 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...
Provision Consulting Group
Oct 21, 20225 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...
Provision Consulting Group
Sep 13, 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...
Provision Consulting Group
Sep 9, 20223 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...
Provision Consulting Group
Sep 8, 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...
Provision Consulting Group
Sep 1, 20222 min read
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