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...
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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...
What are the basic FDA requirements of Unique Device Identification(UDI) System ?
Aug 29 2022 All devices are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted. This...
FDA Medical Device, overview of 510(k) guide
Aug 17 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...
FDA Guidance of OTC Drug
Aug 11 2022 To market OTC Drug products in the U.S, There are two pathways which is submitting a New Drug Application (NDA) for FDA...
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...
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...
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...
FDA Announces Future Format of the National Drug Code
July 22 2022 On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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