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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FDA New Cosmetic Regulation : Modernization of Cosmetics Regulation Act
January 25 2023 On December 29, 2022, The president signed into law: The modernization of Cosmetics Regulation Act of 2022 (MOCRA) which...
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...
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...
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...
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...
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...
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,...
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...
Provision Consulting Group signed a Memorandum of Understanding (MOU) with POSCO International
Nov. 30 2022 On November 16th, Provision Consulting Group, Inc., which specializes in consultation on FDA approval for bio-healthcare and...
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...
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...
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,...
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...
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...
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...
How Cosmetics are Regulated by FDA?
Sep 13 2022 Under the regulation of the FDA, cosmetic products and ingredients do not need FDA premarket approval, with the exception of...
FDA Medical Device, De Novo Process Guide
Sep 09 2022 The new device which is a low to medium risk on the market requires a pathway of the De Novo process. The De Novo request...
FDA Medical Device, overview of 510(k) guide
Sep 08 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...
FDA Regulatory of Hearing Aids
Sep 01 2022 On August 16, 2022, The U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in...
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