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Content of Premarket Submissions for Device Software Functions

Content of Premarket Submissions for Device Software Functions
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Radiological healthOffice of clinicalOffice of combination productsDrug administrationGuidance issuing officeDocket numberBiologics evaluationClinical policyDrug evaluationFederal foodCosmetic actPremarket submissionsSoftware containedMedical devices

5 Hot-Button Issues In Parenteral Packaging

Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.

United statesJean sebastien steffenFranl degrazioBrigitte reutterErika pfeilerEurope european medicines agencyEnvironmental protection agencyOffice of combination productsStrategic parenteral solutionsEuropean chemicals agencyPrefilled syringe interest groupPackaging conferenceMedical device regulationBrigitte reutter hClosure integrityDevice regulation

Except for statements of historical fact, certain information described in this Form 10-Q report contains forward-looking statements that involve substantial risks and uncertainties. You can identify. | May 4, 2023

United statesState of washingtonWashington state universityAlice villalobosCarl cadwellJohns hopkinsHydrogel radiogelRadiological healthNational cancer instituteDavista incAkina incCompany radiogelNuclear regulatory commissionAmerican veterinary medical associationNational cancer institute of the united statesJohns hopkins university

Celularity Receives U S Food And Drug Administration (FDA) Preliminary Assessment For Celularity s Investigational Fuse Bone Void Filler To Be Regulated As A Device By FDA s Center For Devices And Radiological Health

Celularity’s Pre-Request for Designation is based on data demonstrating 100 percent biochemical characterization of the product Celularity intends to submit 510 pre-market notification to the. | April 3, 2023

United statesUnited arab emiratesRobertj haririAbu dhabiAd ports groupRadiologic healthDrug administrationSecurities exchangeCelularity incGlobenewswire incCh trading groupRadiological healthMarket researchExchange commissionOffice of combination productsGrowing middle east distribution agreements

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Marketing Submission Recommendations for Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions

Guidance issuing officeDrug administrationOffice of combination productsRadiological healthOffice of clinicalSubmit commentsBiologics evaluationDrug evaluationClinical policyPredetermined change control plan

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