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Top ten summary points about the FDA guidance on application user fees for combination products: ? Combination products are defined as products comprised of any combination of a drug, device, and/or biological product, as specified in 21 CFR 3.2(e). ? For most combination products, a single marketing application is sufficient for approval, clearance, or licensure. ? The user fee associated with a combination product is determined by the type of marketing application required (e.g. NDA, BLA, PMA, 510(k)). ? When a single application is submitted for a combination product, only one user fee is assessed. ? In rare cases where FDA requires two marketing applications for a combination product, two application fees would ordinarily be assessed. ? The "barrier to innovation" waiver under PDUFA may be applied to reduce the additional fee burden when FDA requires two applications for an innovative combination product. ? Sponsors may be eligible for existing fee waivers or reductions under PDUFA and MDUFMA, such as small business waivers. ? MDUFMA provides more limited waiver options compared to PDUFA, primarily focused on small businesses and specific exemptions. ? Sponsors are encouraged to consult with FDA if uncertain whether one or multiple applications are needed for their combination product. ? The guidance aims to clarify user fee policies for combination products but does not establish legally enforceable responsibilities. Key reasons why this FDA guidance on application user fees for combination products is important: ? It clarifies the user fee policies for combination products, which are increasingly common and complex therapeutic and diagnostic products that combine drugs, devices, and/or biological products. ? It provides updated information on how user fees are assessed for combination products, whether submitted as a single application or separate applications for constituent parts. ? It aligns the guidance with current user fee programs and recent legislative changes regarding combination products in the FD&C Act. Key points that explain why this guidance should be used in conjunction with other FDA guidance documents: ? It explicitly states that it should be used alongside the guidance for industry on Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products. ? It also recommends using the appropriate medical device user fee amendments (MDUFA) guidance documents. ? These additional guidances provide complementary information on user fee programs and potential waivers or reductions that may apply to combination products. By using this guidance in combination with other relevant FDA documents, sponsors can gain a comprehensive understanding of the user fee requirements and potential fee reductions or waivers applicable to their specific combination product submissions. #FDA #RegulatoryAffairs #Regulatory #ClinicalResearch #ClinicalTrials

Since the final FDA ruling on Laboratory Developed Tests was published on 06 May 2024, there has been a great deal of discussion around the interpretation and implications of the new oversight. Reportedly, it is just 10 words that have changed. Find out why it's caused so much turmoil in The FDA Ruling on LDTs: Taking Control of What's in Your Control. Read it here >> https://ow.ly/UinY50T7WJA. #ldt

?? FDA Update Alert! ?? The FDA has issued a revised final guidance for industry, “Application User Fees for Combination Products.” This guidance explains how combination products may be reviewed either in a single application or in separate applications for the constituent parts, as appropriate. ?? Key Takeaways: . Streamlined review processes for combination products . Clarity on application user fees . Flexibility in submission formats to suit your needs For more details, read the full guidance below. #trinitymconsulting #globalconsulting #fda #medicaldevices #regulatoryaffairs

Part 1 of my four part series on getting ready for LDT regulation by the FDA (and brushing up on your Fallout trivia) is now available. And if you hate coming into the middle of the story, make sure to read my the previous blog "Prepare for the Future!" https://lnkd.in/eaaGDVFm

#Savethedate The FDA is hosting a ???????????? ???????????????? ???? ??????. 6, 2024, ???????????? “?????????????????????????? ???????????? ?????? #???????????????????????????????????????? ?????? ?????? ???? #???????????????????????????????? ???? ?????????????? #???????????????????????????????? ???? #????????????????????????????.” The purpose of this workshop is to discuss the possible expansion of the Accreditation Scheme for Conformity Assessment #ASCA program to include chemical analysis to support biocompatibility of medical devices (#ISO10993-18). Read more and register: https://lnkd.in/e62qCAmV ?????? ???????????????????????? ???????????????? ???? ??????. 30, 2024. #medtech #medtechnews #fdacompliance #biologicalsafety

Unveiling FDA Trends! Discover the top Equipment Qualification observations of 2024. Sign up now at?fdatracker.ai?to know more!

About 70% of the warning letters were due to unapproved use of the device in question. Stay ahead of quality issues before they turn into an FDA citation. Learn more about how we can help you avoid and resolve citations- https://oqsie.com/ #fdacitations #medicaldevices #complianceremediation

ICYMI: The FDA’s final guidance on #MedDevice #RemanufacturingRequirements came out last month. Here is a nice summary of the pertinent details. #MedicalDeviceManufacturing #ImprovingPatientsLives #RegulatoryCompliance #MedicalDeviceGuidance

#Didyouknow The FDA has reorganized its section for Searches of FDA Guidance Documents https://lnkd.in/d4Rh_QzY into 2 stand-alone sections?depending on whether special controls are applicable or not: ?? A search specific for guidance documents on Class II Special Controls Documents for specific device types Access it here: https://lnkd.in/dUm9WS9V ?? A search for other guidance documents https://lnkd.in/d4Rh_QzY ????????:?The main page for guidance documents can still be used for standards that apply to various device types and also includes the documents of the Safety and Performance Pathway page https://lnkd.in/d-c4bDm #medtech #medicaldevices #fdacompliance

?? The Critical Role of Biological Evaluation Plans (BEP) in Device Development [Blog post ?? https://lnkd.in/dpueUJxy] The Biological Evaluation Plan (BEP) is fundamental to assessing the safety of medical devices. Our latest article explores how a well-structured BEP supports regulatory success and improves device safety. ?? What You’ll Discover: What is a BEP?: Detailed overview and its importance. Components of a BEP: Device description, material characterization, risk assessment, and testing strategy. Early Integration: Benefits of incorporating the BEP early in development. Regulatory Compliance: Meeting FDA and EU MDR requirements effectively. Enhance your understanding of BEPs and streamline your device development process. Read more here: https://lnkd.in/dpueUJxy ______________________________________ #MedicalDeviceDevelopment #BiologicalEvaluationPlan #RegulatorySuccess #ISO10993 #FDA #EUMDR #RiskManagement #QualityAssurance #DeviceSafety