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NEWS & BLOGS
Blog: Blog2
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 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
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...
Provision Consulting Group
Jun 22, 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...
Provision Consulting Group
Jun 21, 20223 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...
Provision Consulting Group
Jun 20, 20225 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...
Provision Consulting Group
Jun 17, 20223 min read
Technical Performance Assessment of Quantitative Imaging Radiological Device in Premarket Submission
Jun 16 2022 The Food and Drug Administration (FDA) is issuing this guidance to provide recommendations for manufacturers about the...
Provision Consulting Group
Jun 16, 20225 min read
How does FDA regulate Radiation Emitting Medical Device?
Jun 15 2022 Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits...
Provision Consulting Group
Jun 15, 20224 min read
How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated
Jun 14 2022 The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go...
Provision Consulting Group
Jun 14, 20226 min read
When you designing your home use device : FDA Guidance
Jun 13 2022 When developing a new home use device, you should take the considerations in this FDA guidance into account and, to the...
Provision Consulting Group
Jun 13, 20224 min read
Dermal Fillers, Aesthetic Medical Devices Regulated by FDA
Jun 10 2022 Aesthetic (cosmetic) devices are typically used to improve appearance. They may be regulated by FDA depending upon their...
Provision Consulting Group
Jun 10, 20224 min read
FDA Regulation of Product Label with Expiration Dates
Jun 06, 2022 The United States Food and Drug Administration develops and administers regulations under authority granted by laws passed...
Provision Consulting Group
Jun 6, 20223 min read
Quality System FDA Regulation for Medical Devices
Jun 03 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
Provision Consulting Group
Jun 3, 20224 min read
Design Control for Home Use Medical Device Manufacturers
Jun 01 2022 For the manufacturers which Develop a new home-use device, we provide this guidance, and it applies to both prescription and...
Provision Consulting Group
Jun 1, 20223 min read
FDA Regulatory Design Control Requirements for Medical Device Startups
May 23 2022 The U.S. Food and Drug Administration (FDA) recognizes these risks and strictly regulates design control requirements to...
Provision Consulting Group
May 23, 20222 min read
Does your product require FDA Approval?
May 13 2022 Most of the products on the market show a mark or ads that they have been approved by the FDA. And many companies say their...
Provision Consulting Group
May 13, 20225 min read
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