Medical Device Defined

فهرست عناوین اصلی در این پاورپوینت

فهرست عناوین اصلی در این پاورپوینت

● Agenda
● FDA Organizational Chart
● Legislative History
● Medical Device Defined
● Definition (regs)
● Combination Products
Definition
● Combination Products
● FDA Organizational Chart
● Safety & Effectiveness
● CDRH Mission
● CDRH’s Mission
● The products we regulate…
● Who We Are
● CDRH in perspective
● CDRH Organizational Chart
● Office of Science and Engineering Labs
(OSEL)
● OSEL Contributions
● How to Market a Medical Device
● Product Classification
● Determination & Classification
● Class of Medical Devices
● Valid Scientific Evidence
● FDA Quality System Regulation (QSR)
(Good Manufacturing Practice)
● …FDA QSR…
● FDA QSR
● Resources & Initiatives
● Guidance Documents
● Guidance (e.g.) ….
● Medical Device Development Tools (MDDT)
● ….MDDT…
● …MDDT…
● Resources & Initiatives
● Digitalization Across the Health Care Continuum
● 21st Century Cures
● Advancing Digital Health Innovation
● Smart Regulation Principles for Digital Health Technologies
● Digital Health Few Topics e.g.
● Mobile Medical App
● MMA Examples on our Website
● MDDS and the 21 Century Cures
● General Wellness Devices
● Wearables Technologies
● Industry Education Resources

نوع زبان: انگلیسی حجم: 5.48 مگا بایت
نوع فایل: اسلاید پاورپوینت تعداد اسلایدها: 54 صفحه
سطح مطلب: نامشخص پسوند فایل: pptx
گروه موضوعی: زمان استخراج مطلب: 2019/06/07 01:15:56

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عبارات مهم استفاده شده در این مطلب

عبارات مهم استفاده شده در این مطلب

device, ., medical, center, product, act, health, …, cdrh, drug, food, office,

توجه: این مطلب در تاریخ 2019/06/07 01:15:56 به صورت خودکار از فضای وب آشکار توسط موتور جستجوی پاورپوینت جمع آوری شده است و در صورت اعلام عدم رضایت تهیه کننده ی آن، طبق قوانین سایت از روی وب گاه حذف خواهد شد. این مطلب از وب سایت زیر استخراج شده است و مسئولیت انتشار آن با منبع اصلی است.

http://www.nsfiipconf.com/2018springsbirp1/wp-content/uploads/2018/03/Wed-9.30-am-D.-Patwardhan-FDA-Presentation-NSF-SBIR.pptx

در صورتی که محتوای فایل ارائه شده با عنوان مطلب سازگار نبود یا مطلب مذکور خلاف قوانین کشور بود لطفا در بخش دیدگاه (در پایین صفحه) به ما اطلاع دهید تا بعد از بررسی در کوتاه ترین زمان نسبت به حدف با اصلاح آن اقدام نماییم. جهت جستجوی پاورپوینت های بیشتر بر روی اینجا کلیک کنید.

عبارات پرتکرار و مهم در این اسلاید عبارتند از: device, ., medical, center, product, act, health, …, cdrh, drug, food, office,

مشاهده محتوای متنیِ این اسلاید ppt

مشاهده محتوای متنیِ این اسلاید ppt

introduction to us fda regulatory framework nsf sbir phase i grantee program arlington va march ۲۱ ۲ ۱۸ dinesh v patwardhan ph.d. agenda introduction fda organization introduction to centers within fda combination products medical devices amendments safety and effectiveness benefit risk paradigm quality system regulation qsr resources initiatives guidance documents medical device development tools mddt digital health initiative ۲ fda touches ۲ ۲۵ of us economy department of health and human services food and drug administration center for devices and radiological health cdrh center for drug evaluation and research cder center for biologics evaluation and research cber center for veterinary medicine cvm center for food safety and applied nutrition cfsan national center for toxicological research center for tobacco products ctp fda organizational chart ۴ legislative history ۱۹ ۲ biologics control act ۱۹ ۶ food drug act f d act ۱۹۳۸ federal food drug and cosmetic act fd c act ۱۹۶۸ radiation control for health safety act rchsa ۱۹۷۶ medical device amendment of ۱۹۷۶ ۱۹۸۸ clinical laboratory improvement amendments clia ۱۹۹ safe medical devices act smda ۱۹۹۲ mammography quality standards act mqsa ۱۹۹۲ medical device amendments ۱۹۹۷ food drug administration modernization act fdama ۲ ۲ medical device user fee and modernization act mdufma medical device user fee stabilization act mdufsa ۲ ۷ food and drug administration amendments act of ۲ ۷ fdaaa ۲ ۱۲ fda safety and innovation act fdasia ۲ ۱۷ fda reauthorization act fdara ۲ ۱۷ ۵ medical device defined section ۲ ۱ h of the fd c act defines a medical device as …in part… a medical device is an instrument apparatus implement machine contrivance implant in vitro reagent or other similar or related article ..intended for use in the diagnosis of disease or other conditions or in the cure mitigation treatment or prevention of disease in man…. ..intended to affect the structure or any function of the body .. and does not achieve its principal intended purpose by chemical action or by being metabolized. as low risk as a tongue depressor or a thermometer as complex and high risk as robotic surgery devices ۶ definition regs drug in part … …a substance recognized by an official pharmacopoeia or formulary. a substance intended for use in the diagnosis cure mitigation treatment or prevention of disease. a substance other than food intended to affect the structure or any function of the body….. fd c act sec. ۲ ۱ g ۱ cosmetic in part ….articles intended to be rubbed poured sprinkled or sprayed on introduced into or otherwise applied to the human body …for cleansing beautifying promoting attractiveness or altering the appearance…. fd c act sec. ۲ ۱ i . and so on… ۲۱ cfr ۳.۲ e combination products are therapeutic and diagnostic products that combine drugs devices and or biological products lead center is based on primary mode of action pmoa office of combination products combination products definition ۸ device coated or impregnated with a drug or biologic drug eluting stent pacing lead with steroid coated tip catheter with antimicrobial coating examples of combination products where the components are packaged together drug or biological product packaged with a delivery device combination products ۹ combination products department of health and human services food and drug administration center for devices and radiological health cdrh center for drug evaluation and research cder center for biologics evaluation and research cber center for veterinary medicine cvm center for food safety and applied nutrition cfsan national center for toxicological research center for tobacco products ctp fda organizational chart ۱۱ there is reasonable assurance that a device is safe when it can be determined based on valid scientific evidence that the probable benefits to health from use of the device for its intended uses and conditions of use when accompanied by adequate directions and warnings against unsafe use outweigh the probable risks. there is reasonable assurance that a device is effective when it can be determined based upon valid scientific evidence that in a significant portion of the target population the use of the device for its intended uses and conditions of use when accompanied by adequate directions for use and warnings against unsafe use will provide clinically significant results. safety effectiveness ۱۲ cdrh mission the mission of the center for devices and radiological health cdrh is to protect and promote the public health. we assure that patients and providers have timely and continued access to safe effective and high quality medical devices and safe radiation emitting products. we provide consumers patients their caregivers and providers with understandable and accessible science based information about the products we oversee. we facilitate medical device innovation by advancing regulatory science providing industry with predictable consistent transparent and efficient regulatory pathways and assuring consumer confidence in devices marketed in the u.s. ۱۳ cdrh’s mission risks benefits bring safe and effective medical devices to market as quickly as possible… … while ensuring that medical devices currently on the market remain safe and effective. provide consumers patients caregivers and providers with understandable and accessible science based information about the products we oversee. reference cdrh mission vision and share values ۱۴ the products we regulate… ۱۵ who we are cdrh is a team of over ۱۷ employees dedicated to public health engineers physicians biologists chemists physicists statisticians epidemiologists microbiologists nurses veterinarians toxicologists public health education communication specialists attorneys ۱۶ cdrh in perspective cdrh oversees ۱۷۵ medical devices on us market ۵۷ proprietary brands on the us market ۱۸ medical device manufacturers ۲۵ medical device facilities worldwide each year we receive ۲۲ premarket submissions includes supplements and amendments ۱.۴ million reports on medical device adverse events and malfunctions ۸ of device companies have ۵ staff cdrh ombudsman center for devices and radiological health office of in vitro diagnostics and radiological health office of compliance office of science and engineering laboratories office of communication and education office of surveillance and biometrics office of management operations office of device evaluation cdrh organizational chart ۱۸ office of science and engineering labs osel ensure readiness for emerging and innovative medical technologies develop appropriate evaluation strategies and understandable public health info. our job is to ensure that cdrh never has to say i don’t know division of applied mechanics biology chemistry and material science biomedical physics imaging diagnostics and software reliability. ۱۹ osel contributions providing scientific engineering expertise data and analyses conducting laboratory based regulatory research regulatory science programs facilitate innovation collaboration https www.fda.gov aboutfda centersoffices officeofmedicalproductsandtobacco cdrh cdrhoffices ucm۱۱۵۹۸۹.htm how to market a medical device device product determination device product classification determine appropriate …

کلمات کلیدی پرکاربرد در این اسلاید پاورپوینت: device, ., medical, center, product, act, health, …, cdrh, drug, food, office,

این فایل پاورپوینت شامل 54 اسلاید و به زبان انگلیسی و حجم آن 5.48 مگا بایت است. نوع قالب فایل pptx بوده که با این لینک قابل دانلود است. این مطلب برگرفته از سایت زیر است و مسئولیت انتشار آن با منبع اصلی می باشد که در تاریخ 2019/06/07 01:15:56 استخراج شده است.

http://www.nsfiipconf.com/2018springsbirp1/wp-content/uploads/2018/03/Wed-9.30-am-D.-Patwardhan-FDA-Presentation-NSF-SBIR.pptx

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