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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Aug 8, 20224 min read
FDA Medical Device : Determining your path to U.S market
Aug 08 2022 Classification of Medical Devices For your medical device to entrance in the U.S market, classifying your medical device will...
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Provision Consulting Group
Aug 3, 20223 min read
FDA 513(g) Requests Procedures Information Guidance
Aug 3 2022 The 513(g) Request is for the medical device manufacturers who submitting, reviewing, and responding to classify particular...
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Provision Consulting Group
Jul 22, 20224 min read
FDA Announces Future Format of the National Drug Code
July 22 2022 On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label...
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Provision Consulting Group
Jul 12, 20224 min read
FDA Medical Device, Overview of Q-Submissions
July 12 2022 Q-Submission offers important opportunities for you to share information with FDA and receive input outside of the...
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Provision Consulting Group
Jun 29, 20222 min read
What are the basic MDR requirements from FDA?
Jun 29 2022 The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events such as deaths and serious...
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Provision Consulting Group
Jun 23, 20223 min read
Steps to Get a New Medical Device to Market
Jun 23 2022 Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic...
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Provision Consulting Group
Jun 22, 20223 min read
Medical Device Pathway to FDA Approval
Jun 22 2022 Step 1 Device Discovery and Concept Medical device development follows a well-established path. Many of these steps overlap...
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Provision Consulting Group
Jun 21, 20223 min read
What are the requirements of Quality System FDA Regulation?
Jun 21 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
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Provision Consulting Group
Jun 20, 20225 min read
When the De Novo Classification Process May and May Not Be Used
Jun 20 2022 In accordance with section 513(f)(2) of the FD&C Act, you may submit a De Novo request for FDA to make a classification...
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Provision Consulting Group
Jun 17, 20223 min read
FDA Regulation for Importing Medical Device
Jun 17 2022 The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in...
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