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NEWS & BLOGS
Blog: Blog2
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...
Provision Consulting Group
Aug 29, 20223 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...
Provision Consulting Group
Aug 17, 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...
Provision Consulting Group
Aug 11, 20222 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...
Provision Consulting Group
Aug 10, 20223 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...
Provision Consulting Group
Aug 8, 20224 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...
Provision Consulting Group
Aug 3, 20223 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...
Provision Consulting Group
Jul 22, 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...
Provision Consulting Group
Jul 12, 20224 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...
Provision Consulting Group
Jun 29, 20222 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...
Provision Consulting Group
Jun 23, 20223 min read
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