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    FDA Regulatory Design Control Requirements for Medical Device Startups
    Provision Consulting Group
    • 1 day ago

    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...
    Does your product require FDA Approval?
    Provision Consulting Group
    • May 14

    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...
    FDA approves OCS(Organ Care System) Heart System new medical technology
    Provision Consulting Group
    • May 11

    FDA approves OCS(Organ Care System) Heart System new medical technology

    May 11 2022 The U.S. Food and Drug Administration(FDA) granted PMA(Premarket Approval) for OCS Heart System its donor hearts for...
    FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease
    Provision Consulting Group
    • May 6

    FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

    05 05 2022 The U.S. Food and Drug Administration permitted marketing for the first in vitro diagnostic test for early detection of...
    How to accelerate the FDA approval process time?
    Provision Consulting Group
    • May 3

    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....
    Counterfeit At-Home OTC COVID-19 Diagnostic Tests
    Provision Consulting Group
    • May 2

    Counterfeit At-Home OTC COVID-19 Diagnostic Tests

    May 02 2022 The FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the...
    FDA approves new drug to improve heart function in adults with rare heart condition
    Provision Consulting Group
    • Apr 30

    FDA approves new drug to improve heart function in adults with rare heart condition

    Apr 29 2022 FDA has approved Camzyos (mavacamten) capsules to treat adults with symptomatic New York Heart Association (NYHA)External...
    At-Home COVID-19 Diagnostic Tests Q&A
    Provision Consulting Group
    • Apr 29

    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...
    FDA Approves First COVID-19 Treatment for Young Children
    Provision Consulting Group
    • Apr 27

    FDA Approves First COVID-19 Treatment for Young Children

    Apr 27 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include...
    FDA, OTC Medical Devices Q&A for Device Manufacturers
    Provision Consulting Group
    • Apr 20

    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...
    FDA, OTC skin lightening products
    Provision Consulting Group
    • Apr 19

    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...
    FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
    Provision Consulting Group
    • Apr 14

    FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

    Apr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...
    How to prepare a De Novo Request?
    Provision Consulting Group
    • Apr 13

    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...
    In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
    Provision Consulting Group
    • Apr 9

    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...
    FDA approves alpelisib for PIK3CA-related overgrowth spectrum
    Provision Consulting Group
    • Apr 8

    FDA approves alpelisib for PIK3CA-related overgrowth spectrum

    Apr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...
    FDA updates Sotrovimab emergency use authorization
    Provision Consulting Group
    • Apr 5

    FDA updates Sotrovimab emergency use authorization

    Apr 05 2022 Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion...
    FY 2023-2027 FDA Medical Device User Fee Amendment (MDUFA V)
    Provision Consulting Group
    • Apr 5

    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...
    Allergens in Cosmetics
    Provision Consulting Group
    • Mar 29

    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...
    FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines
    Provision Consulting Group
    • Mar 29

    FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines

    Mar 29 2022 The U.S. Food and Drug Administration(FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna...
    FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4
    Provision Consulting Group
    • Mar 28

    FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4

    Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...
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