Assignment: Laser Therapy and BTL 4000 Series Project

Assignment: Laser Therapy and BTL 4000 Series Project ORDER NOW FOR CUSTOMIZED AND ORIGINAL ESSAY PAPERS ON Assignment: Laser Therapy and BTL 4000 Series Project hi how are you this project something new make a new thing never be in hospital before. Assignment: Laser Therapy and BTL 4000 Series Project powerpoint and put a note for each slide also report more then 5 pages my project is laser therapy Project Report and Presentation Slide Deck shall include: 1. Title of the machine, or device, or components, or special facility of your project 2. Description of your project purpose, benefits to users, risk of your product and impact assessment 3. Project checklist 4. Documentation: patent filing, 510k filing, other legal filing, etc. 5. Presentation report and slide deck Additional Information for “Project Preparation Report”: 1. Phase One: “Project Scope of Work” preparation report in power presentation format 1. Identifier and Discovery (one slide or more) 1. Your identifier (findings): what is un-met need; what is your new need that is not available today 2. Provide study statement and evidences to justify your opinion / idea 2. Invent and Design Concept (two slides or more) 1. Brain Storm and Technical Evaluation: explore your idea, concept and opportunities for improvement, new development 2. Technical Assistance: using graphics, pictures, models, video and engineering design concept to demonstrate your Invent / Design Concept Regulatory study: GMP requirements, product application, product’s efficacy safety and quality evaluation 2. Phase Two “Invent and Implementation” attachment_1 attachment_2 attachment_3 attachment_4 Medical Device Supplemental Study Mat BME338 Overview • An overview of medical devices and requirements that the FDA verifies/e at the time they are imported or offe import into the United States. • The Center for Devices and Radiolog Health (CDRH) is the FDA center resp for overseeing the medical device pr 11/6/2020 Supplemental Study – BME338 What is a medical de The FDA defines a medical device as: • • • “an instrument, apparatus, implement, machine, contrivan vitro reagent, or other similar or related article, including a part or accessory which is: recognized in the official Nation the United States Pharmacopoeia, or any supplement to th intended for use in the diagnosis of disease or other condi cure, mitigation, treatment, or prevention of disease, in m animals, or intended to affect the structure or any function of the bod other animals, and which does not achieve its primary inte through chemical action within or on the body of man or o and which is not dependent upon being metabolized for th of any of its primary intended purposes.” Is my invent a medical de 11/6/2020 Supplemental Study – BME338 If your product is labeled or used in a m that meets this definition it will be regu a medical device and is subject to the F and regulations before, during, and aft offered for sale or use in the United St 11/6/2020 Supplemental Study – BME338 HOW TO STUDY AND MARKE INVENTS OF MEDICAL DEVICE How to Study and Market Your 11/6/2020 Supplemental Study – BME338 • Medical devices marketed in the United States a the regulatory controls in the Federal Food, Drug Cosmetic Act (FD&C Act) and the regulations in T of Federal Regulations (21 CFR) Parts 1-58, 800-1 • The regulatory controls and marketing pathways the risk of the device the regulatory controls nee ensure reasonable assurance of safety and effect • The marketing pathways include: Premarket Not (510(k)), De Novo Classification Request, Exempt Approval (PMA), Product Development Protocol Humanitarian Use Exemption (HDE), and Biologic Application (BLA). 11/6/2020 Supplemental Study – BME338 Premarket Requiremen • Bringing a device to the market in the Un States may appear complex. Following th steps may assist you to navigate the pro • Four steps to bring a device to the mark Step One: Classify Your Device and Understand Regulatory Controls Step Two: Select and Prepare the Correct Prem Submission Step Three: Send your Premarket Submission t and Interact with FDA Staff During Review Step Four: Comply with Applicable Regulatory Including the Establishment Registration and D 11/6/2020 Supplemental Study – BME338 Step One: Classify Your Devi Understand Applicable Cont • The first step in preparing a device for marketin United States is to determine how the FDA has your device. A medical device is defined by law section 201(h) of the Federal Food, Drug and C (FD&C) Act. • Medical devices are categorized into one of thr (I, II, or III), based on the degree of risk they pr device class increases from class I to class II to the regulatory controls also increase, with clas subject to the least regulatory control, and clas devices subject to the most stringent regulator Assignment: Laser Therapy and BTL 4000 Series Project The classes of devices, regulatory controls and submission types are summarized in the table: 11/6/2020 Supplemental Study – BME338 Device Class and Submissio Class Risk Regulatory Controls Potential Harm I Lowest II Moderate Higher risk than class I devices General and Special (if available) III Highest 11/6/2020 Present minimal potential for harm General Sustain or support life, are General and implanted, or present PMA potential unreasonable risk of illness or injury Supplemental Study – BME338 What Should You Know • If product is a combination product – a med plus another FDA-regulated product (e.g. dr biologics, etc.), you should contact FDA’s O Combination Product (OCP) by e-mail at: [email protected] for direction of FDA Center based on your product’s primary mo action in order to market your product. • If your medical device does not require a pr submission, you must still identify the corre classification for your device to understand comply with the applicable regulatory contr 11/6/2020 Supplemental Study – BME338 Step Two: Select and Prepar Correct Premarket Submis • You should select and prepare the appropriate prema submission, if one is required for your specific produc classification. For most medical devices, the appropri submission type is identified within the product class which may be obtained from the public Product Class database. Note some device types do not require a p submission. For more information refer to the Class I webpage. If you determine no premarket submission your device, you may skip Steps Two and Three, and Step Four. The most common types of premarket sub include: – – – – 11/6/2020 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request HDE (Humanitarian Device Exemption) Supplemental Study – BME338 Premarket Notification Form: • Some class I and most class II devices require a 510(k), the sponsor must demonstrate that the is “substantially equivalent” to a predicate dev of intended use, technological characteristics, a performance testing, as needed. For informatio prepare and submit a 510(k), see Device Advice Notification [510(k)]. • Some class I and class II devices are exempt fro notification requirement, if they do not exceed limitations of exemption stated in 21 CFR xxx.9 refers to 21CFR 862-892. For example, an elast classified under 21CFR 880.5075 is exempt from notification, provided that it does not exceed t exemption limitations stated in 21CFR 880.9. 11/6/2020 Supplemental Study – BME338 Premarket Approval (PM • Class III devices require a PMA. A PMA most stringent type of premarket subm Before the FDA approves a PMA, the sp must provide valid scientific evidence demonstrating reasonable assurances o and effectiveness for the device’s inten • For information on how to prepare and PMA, see Device Advice Premarket App (PMA). 11/6/2020 Supplemental Study – BME338 De Novo Classification Req • The De Novo process provides a pathway to novel medical devices for which general con or general and special controls, provide rea assurance of safety and effectiveness for th use, but for which there is no legally marketed predicate device. For information prepare and submit a De Novo request, ple these resources: – FD&C Act, section 513(f)(2) – DeNovo Classification Request (De Novo Proc – Evaluation of Automatic Class III Designation Process) Summaries 11/6/2020 Supplemental Study – BME338 Humanitarian Device Exemptio • HDE provides a regulatory pathway for class III device • • intended to benefit patients with rare diseases or con order for a device to be eligible for an HDE, a sponsor obtain designation as a Humanitarian Use Device (HU granted through an application to FDA’s Office of Orp Development (OOPD). For information on how to request Humanitarian Use see Designating Humanitarian Use Device (HUD). For information on how to prepare and submit an HD please refer to these resources: – 21CFR 814, Subpart H – Humanitarian Device Exemption – Humanitarian Device Exemption (HDE) Program Guida 11/6/2020 Supplemental Study – BME338 Additional Resources: Prepa Premarket Submission • The FDA has developed several different types of resources to he premarket submission. Assignment: Laser Therapy and BTL 4000 Series Project These include the following: • CDRH Learn: A video-based series of teaching modules, seminars webinars that cover a variety of policy and guidance efforts. • CDRH’s Q-Submission Program: Prospective applicants of future p submissions may request feedback from the FDA through a Pre-S is part of the Q-Submission Program. Information about this prog found in the FDA guidance Requests for Feedback and Meetings Device Submissions: The Q-Submission Program. We encourage y online information and other available resources prior to sending feedback. • CDRH Breakthrough Devices Program: This voluntary program he more timely access to certain medical devices that treat or diagn lifethreatening or irreversibly debilitating condition by speeding u development, assessment, and review. Devices subject to Prema applications (PMAs), premarket notifications [510(k)] or De Novo 11/6/2020 Supplemental Study – BME338 requests may be eligible. Sponsors can send a Breakthrough Desi for their device at any time prior to sending the device’s marketin Design Controls • Class II and class III devices must be d in accordance with Design Controls u Quality System Regulation (21 CFR 8 • Some class I devices are exempted fr Design Controls. For additional inform Design Controls, please see: Design C Guidance for Medical Device Manufa 11/6/2020 Supplemental Study – BME338 Nonclinical Testing • • • The types of information and testing required to market your device are d device classification, mechanisms of operation, technological characterist Nonclinical testing performed in support of a premarket submission for a should comply with the Good Laboratory Practices (GLPs) in 21 CFR 58. Fo information please see Recommended Content and Format of Complete T Non-Clinical Bench Performance Testing in Premarket Submissions. The FDA encourages the use of FDA-recognized consensus standards in pr submissions. Conformance is voluntary, unless a standard is incorporated regulation see the Standards (Medical Devices) Federal Register Documen of a least-burdensome approach to device review is a reliance upon intern standards, therefore, the FDA issued a draft guidance entitled The Accred Conformity Assessment (ASCA) Pilot Program : Draft Guidance for Industry Bodies, Testing Laboratories, and FDA Staff. This voluntary, pilot program, increase consistency and predictability in the FDA’s approach to assessing ASCA-eligible standards in medical device premarket reviews. Clinical Evidence: PMAs, HDEs and some 510(k)s and De Novo Classificatio clinical evidence. Prior to initiating a clinical study, the study sponsor may approval of an Investigational Device Exemption (IDE) by the FDA. The stu be approved by the appropriate Institutional Review Board (IRB). Clinical s with all applicable IDE regulations and Good Clinical Practices (GCPs). For information on the IDE and GCP regulations, see Investigational Device Ex 11/6/2020 Supplemental Study – BME338 Labeling • The labeling for a device must be written according to regulations and included in your premarket submissio • For information on Device Labeling, please refer to th • 21 CFR 801 Labeling • Device Labeling and Unique Device Identification Syst • FDA has established a unique device identification (U adequately identify medical devices through their dis use. The UDI rule became final in September 2013 an phased in over several years, based primarily on devi classification. When fully implemented, the UDI Syste range of benefits to industry, FDA, consumers, health providers and health care systems including improve safety and post market surveillance. For more inform requirements please refer to the following reference – Unique Device Identification (UDI) – Global UDI Database (GUDID) 11/6/2020 Supplemental Study – BME338 – CDRH Learn (UDI Modules) Appropriate Information for the Pr Submission • Once you have prepared the appropria premarket submission for your device, to send your submission to the FDA and with FDA staff during its review. Assignment: Laser Therapy and BTL 4000 Series Project Before your submission to the FDA, you should of the following: – Medical Device User Fees – Small Business Determination Program (SB 11/6/2020 Supplemental Study – BME338 – cCopy – Administrative Review – Interactive Review Knowing the Process for 510(k) Submission Before sending your submission to the FDA, you should the following: • Medical Device User Fees: There is a user fee associa submission of certain marketing applications. For info which applications are subject to user fees, and the u those applications, please see Medical Device User Fe 11/6/2020 Supplemental Study – BME338 • Small Business Determination (SBD) Program: A bus qualified and certified as a “small business” is eligible substantial reduction in most of these user fees. For m information on the SBD Program, please see Reduced Device User Fees: Small Business Determination (SBD • eCopy: Premarket submissions must include an elect (eCopy) on a compact disc (CD), digital video disc (DV drive. For detailed information on how to prepare yo please see eCopy Program for Medical Device Submis Knowing the Process for 51 Submission Once your submission has been received by the FDA, yo aware of the following: • Administrative Review: After a premarket submissio the FDA conducts an administrative review to assess 11/6/2020 Supplemental Study – BME338 submission is sufficiently complete to be accepted fo review. Please see the Refuse to Accept Policy for 510(k)s, Acceptance and Filing Reviews for Premarket Applications (PMAs) or Acceptance Review for De No Classification Requests and Humanitarian Device Exe Program: Guidance for Industry and Food and Drug A Staff. • Interactive Review: While a submission is under revie communicates with applicants to increase the efficien review process. Please see: Types of Communication Review of Medical Device Submissions. Step Four: Comply with Applicable Reg Controls, Including Establishment Registra Device Listing 11/6/2020 Supplemental Study – BME338 • Regulatory controls are risk-based requirements that apply devices and give FDA the oversight to ensure the reasonab effectiveness of medical devices. • Devices in all three classes (Class I, II, and III) are subject to controls, unless exempted by regulations, which require, in device facilities: (1) register their establishments and list th devices they market with FDA; (2) manufacture their devic accordance with Good Manufacturing Practices; (3) label t accordance with labeling regulations; and (4) cannot be ad misbranded. If a device is exempted from one of the gener such exemption is stated in the classification regulation fo • A device facility must register its establishment and list its FDA. Information about how to register and list may be fou Registration and Listing. • If a device requires a premarket submission prior to marke medical device is not exempt), the device facilities must w receives FDA clearance or approval before registering and 11/6/2020 Supplemental Study – BME338 • Registration of a device establishment, assignment of a reg number, or listing of a medical device does not in any way clearance or approval of the establishment or its products • Seeking for Device Advice from FDA – Food and Drug Administration’s (FDA’s Center for Devices and Radiological He (CDRH) web page for comprehensive regulatory education. 11/6/2020 Supplemental Study – BME338 – Device Advice is CDRH’s premier text-b resource that explains many aspects of medical device laws, regulations, guida and policies, encompassing the entire p life cycle. 11/6/2020 Supplemental Study – BME338 Define Strategy for Identify Inventing, and Implementa 25 Breast Implants O2 Level Testor Lab Instruments EKG Dental apparatus 11/6/2020 Supplemental Study – BME338 thermo Final Exam Presenta Template Your Name BME338 Fall 2020 Faculty & Industry Advi Sample Slides Assignment: Laser Therapy and BTL 4000 Series Project • Students may use the template and form this slide deck • See “sample statements” for reference • Adding graphics, charts, tables, pictures appropriate with clear title for each Problem and Disease State Funda (Include Anatomy and Pathophys Sample statements: • 5 million people receive central line cath • 1/20 of the 5 million have bloodstream i • Approximately .6 – 2.7 billion dollars spe central lines due to extra cost of infectio Current Treatments Sample statements: • Treat Infections – – – – Antibiotics Creams Steroids Is it too late and you are screwed? • Surrogate Testing for Infections – Any redness or swelling at site? – Is the site hot to the touch? – Is there oozing? – Are there pustules and scabs? Strategic Focus & Stakeh Sample statements: • Company’s Mission Statement, Strength/Weakness, Acceptance Criteri Unmet Need • How the unmet need affects the identifie stakeholders Need Statement & Specifi Sample statements: • We need to reduce the incidence of bloo infections in patients with central lines • Specifications (should be measurable/a – Low Cost – One-size Fits All – Maintain Central-Line Function Concepts Sample statements: • Early detection pH Dermal Patch – Changes color when skin turns alkaline (5 – – Alerts clinicians to presence of bacteria gro infection – Dressing can be adjusted to various cathete for patients of different sizes and ages Claims Sample statements: We claim a infection detection method com – pH Skin Test • Bandage changes color when bact present and infection is happening – Temperature Skin Test • Bandage changes color when feve occurring • Color change occurs once skin has degrees F Killer Experiment Sample statements: • Investors would make sure their devise c perform an experimental design (most a to fail your device FDA Timeline and Co Sample statements: • Class 2 – Sterile, early detection of alkaline pH and p infection to save lives – Patch lasts 3 days, changes color when ski pH – Biocompatible • Time – 6 months submission + 4 month • Cost – Approximately $100 K • Regulatory strategy: pre-submiss Implications Sample statements: • Nursing • Healthcare industry • Healthcare professionals • Patients References Thank You! Rules • Submit Presentation Material and Slide day before your presentation • Presentation time no more than 15 minu • Q/A session time no more than 15 minu Tips • Have well designed and reviewed slides with b • Insert References as appropriate • Create a prototype to convince your investors a workable idea • Use videos and graphics to engage the audien understand your vision • Insert slide numbers • Include Market Analysis • Be creative with including competitors flyers a in them or enhance your product specification Presentation Details • Must upload all presentations before Fin Presentation Day in power point format. • If you have any videos – share the link o them as well with the power point subm • No exceptions. … Get a 10 % discount on an order above $ 100 Use the following coupon code : NURSING10

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