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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Jun 16, 20225 min read
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...
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Provision Consulting Group
Jun 15, 20224 min read
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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Provision Consulting Group
Jun 14, 20222 min read
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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Provision Consulting Group
Jun 14, 20226 min read
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...
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Provision Consulting Group
Jun 13, 20224 min read
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...
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Provision Consulting Group
Jun 10, 20224 min read
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...
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Provision Consulting Group
Jun 6, 20223 min read
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...
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Provision Consulting Group
Jun 3, 20224 min read
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...
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Provision Consulting Group
Jun 1, 20223 min read
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...
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Provision Consulting Group
May 25, 20222 min read
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...
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