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NEWS & BLOGS
Blog: Blog2
FDA, Classify Your Medical Device
December 29 2022 There are a number of pathways available to bring a medical device to market. The regulatory pathway for a specific...
Provision Consulting Group
Dec 29, 20222 min read
FDA, What does FDA consider in determining whether to classify a product as a drug or device?
December 28 2022 FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth...
Provision Consulting Group
Dec 28, 20222 min read
FDA Medical Device, Frequently Asked Questions for (OTC) Device Manufacturers
December 23 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words,...
Provision Consulting Group
Dec 23, 20223 min read
FDA Medical Device, Quality System and cGMP
December 22 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
Provision Consulting Group
Dec 22, 20224 min read
Provision Consulting Group signed a Memorandum of Understanding (MOU) with POSCO International
Nov. 30 2022 On November 16th, Provision Consulting Group, Inc., which specializes in consultation on FDA approval for bio-healthcare and...
Provision Consulting Group
Nov 30, 20222 min read
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
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