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NEWS & BLOGS
Blog: Blog2
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
59
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
112
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
25
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
68
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
48
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
25
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
89
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
138
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
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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
28
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
37
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
64
How to accelerate the FDA approval process time?
Apr 28 2022 In the medical device industry, time is the most important thing to your device market in the United States after innovation....
Provision Consulting Group
May 3, 20224 min read
37
At-Home COVID-19 Diagnostic Tests Q&A
Apr 28 2022 At-home COVID-19 tests safety FDA authorized at-home COVID-19 tests are safe to use when people follow the manufacturer’s...
Provision Consulting Group
Apr 28, 20225 min read
21
FDA, OTC Medical Devices Q&A for Device Manufacturers
Apr 20 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these...
Provision Consulting Group
Apr 20, 20228 min read
168
FDA, OTC skin lightening products
Apr 19 2022 FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing...
Provision Consulting Group
Apr 19, 20223 min read
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How to prepare a De Novo Request?
Apr 12 2022 In the United States, successfully launching a product is as important as developing a new medical device. Let's take a look...
Provision Consulting Group
Apr 13, 20223 min read
115
In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...
Provision Consulting Group
Apr 8, 20222 min read
45
FY 2023-2027 FDA Medical Device User Fee Amendment (MDUFA V)
Apr 04 2022 On April 19, 2022, the United States Food and Drug Administration(FDA) will provide a virtual MDUFA V public meeting that is...
Provision Consulting Group
Apr 4, 20223 min read
310
Allergens in Cosmetics
Mar 29 2022 Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some...
Provision Consulting Group
Mar 29, 20222 min read
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