Jun 22 2022 Step 1 Device Discovery and Concept Medical device development follows a well-established path. Many of these steps overlap...

Jun 21 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...

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...

Jun 17 2022 The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in...

Jun 16 2022 The Food and Drug Administration (FDA) is issuing this guidance to provide recommendations for manufacturers about the...

Jun 15 2022 Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits...

Jun 14 2022 FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to...

Jun 14 2022 The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go...

Jun 13 2022 When developing a new home use device, you should take the considerations in this FDA guidance into account and, to the...

Jun 10 2022 Aesthetic (cosmetic) devices are typically used to improve appearance. They may be regulated by FDA depending upon their...