FDA warns Artri and Ortiga products, which may contain hidden drug ingredients
Jun 14 2022 FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to...
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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...
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...
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...
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...
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...
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...
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
May 25 2022 The Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed...
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?
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
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
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?
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
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
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
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
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
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
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
Apr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...
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