FDA has Stopped Voluntary Cosmetic Registration Program(VCRP) to the Mandatory Cosmetic Registration
April 5 2023 On March 27, 2023, the FDA update announced that has stopped accepting submissions to the Voluntary Cosmetic Registration...
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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Feb 22, 20232 min read
FDA Guidance, Clinical Decision Support Software(CDS)
February 22 2023 The US Food and Drug Administration has released final guidance for clinical decision software (CDS) functions,...
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Provision Consulting Group
Feb 17, 20232 min read
Product-Specific Guidance Meeting between FDA and ANDA applicants
February 17 2023 On February 17, 2023, FDA published a new draft guidance for industry, “Product-Specific Guidance Meetings Between FDA...
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Provision Consulting Group
Feb 10, 20232 min read
FDA Regulatory Focus on Compounding Children's Ibuprofen in Response to Increased Demand
February 10 2023 The guidance issued by the Food and Drug Administration (FDA) was released due to an increase in demand for pediatric...
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Provision Consulting Group
Feb 8, 20232 min read
FDA Compliance Label Review, How vital is it?
Feburary 08 2023 The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed...
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Provision Consulting Group
Jan 27, 20232 min read
What to know FDA Import Alerts & Import Refusals?
January 27 2023 Import Alerts notifies that a product is subject to detention without physical examination (DWPE) because it violates or...
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Provision Consulting Group
Jan 25, 20232 min read
FDA New Cosmetics Regulation: MoCRA (Modernization of Cosmetics Regulation Act)
January 25, 2023 On December 29, 2022, The president signed a new law: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA),...
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Provision Consulting Group
Jan 6, 20233 min read
What to know FDA regulation before Cosmetic products go on the U.S. market?
January 6 2023 Among the important differences between requirements for cosmetics in the United States and various other countries are...
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Provision Consulting Group
Jan 5, 20232 min read
What should I expect during an FDA audit?
January 5, 2023 Under the Federal Food, Drug and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years...
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Provision Consulting Group
Jan 4, 20233 min read
FDA Medical Device: How to prepare a 510(k)?
January 04 2023 There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and...
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Provision Consulting Group
Dec 29, 20222 min read
FDA, Classify Your Medical Device
December 29 2022 There are a number of pathways available to bring a medical device to market. The regulatory pathway for a specific...
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Provision Consulting Group
Dec 28, 20222 min read
FDA, What does FDA consider in determining whether to classify a product as a drug or device?
December 28 2022 FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth...
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Provision Consulting Group
Dec 23, 20223 min read
FDA Medical Device, Frequently Asked Questions for (OTC) Device Manufacturers
December 23 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words,...
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Provision Consulting Group
Dec 22, 20224 min read
FDA Medical Device, Quality System and cGMP
December 22 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
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Provision Consulting Group
Nov 11, 20222 min read
An Overview of 510(k) Electronic Submission Guidance for FDA 510(k) Submissions
Nov 11 2022 On October 3, 2022 the FDA announced that sending electronic copy (eCopy) or electronic Submission Template And Resource...
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Provision Consulting Group
Nov 7, 20222 min read
Reminder: FDA New Medical Device User Fees for FY 2023
Nov 07 2022 On October 5th, 2022, the FDA has announced the Fiscal Year (FY) 2023 fees under the MDUFA (Medical Device User Fee...
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Provision Consulting Group
Oct 28, 20225 min read
FDA Guidance for Medical Device Data Systems, MedicalImage Storage Devices, and Medical Image Device
October 28 2022 The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better,...
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Provision Consulting Group
Oct 25, 20223 min read
Overview of Premarket Approval PMA
October 25 2022 Who can submit a PMA? The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to...
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Provision Consulting Group
Oct 24, 20223 min read
FDA Class 1 Medical Devices : UDI Requirements
October 24 2022 FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database...
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Provision Consulting Group
Oct 21, 20225 min read
FDA UDI Guidance of Legacy Identification Number (NDC/NHRIC)
October 21 2022 FDA has announced the availability of final guidance entitled “Enforcement Policy Regarding Use of National Health...
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