A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
How to get your COVID-19 Related Medical Device to Market Under FDA Emergency...Greenlight Guru
What quality and regulatory steps are needed to get your COVID-19 related device on the market under FDA Emergency Use Authorization. The FDA has been very active in publishing new guidances and updates for COVID-19 related devices that are in high demand. RookQS has worked with many manufacturers and distributors around the world to address the COVID-19 related shortages on devices, diagnostics, and PPE.
• Overview of the requirements for the COVID related devices and supplies under high demand during the current COVID pandemic
• Overview on diagnostic and at home testing kits
• Overview on hand sanitizer registration and testing for manufacturers and distributors
• Overview on respirator regulations and testing for manufacturers and distributors
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices.
They may be simple tools used during medical examinations,
such as tongue depressors and thermometers, or high-tech life-saving devices that are implanted in the patient, like pacemakers and coronary stents.
The federal agency responsible for regulating medical devices is the Food and Drug
Administration (FDA)—an agency within the Department of Health and Human Services (HHS).
A manufacturer must obtain FDA’s prior approval or clearance before marketing many medical
devices in the United States.
FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device premarket review.
Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood collection and processing procedures, cellular products and tissues.
Under the terms of the Medical Device Amendments of 1976
FDA classified all medical devices that were on the market at the time of enactment— the Pre amendment devices—into one of three classes.
Congress provided definitions for the three
classes—Class I, Class II, and Class III—based on the risk (low-, moderate-, and high-risk
respectively) to patients posed by the devices.
A PMA is “the most stringent type of device marketing application required by FDA” for new and/or high-risk devices.
PMA approval is based on the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s)
PMAs generally require some clinical data prior to FDA making an approval decision.
All clinical evaluations of investigational devices (unless exempt) must have an investigational device exemption (IDE) before the clinical study is initiated.
An IDE allows an unapproved device (most commonly an invasive or life-sustaining device) to be used in a clinical study to collect the data required to support a PMA submission.
The IDE permits a device to be shipped lawfully for investigation of the device without requiring that the manufacturer comply with other requirements of the FFDCA, such as registration and listing.
A PMA must contain (among other things) the following information:
summaries of nonclinical and clinical data supporting the application and conclusions drawn from the studies;
a device description including significant physical and performance characteristics;
indications for use, description of the patient population and disease or condition that the device will diagnose, treat, prevent, cure, or mitigate;
a description of the foreign and U.S. marketing history, including if the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device;
proposed labeling; and
a description of the manufacturing process.
If a manufacturer wants to make a change to an approved PMA device.
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
Poster Presentation - FDA Compliance Landscape & What it Means to Your AI Asp...CitiusTech
CitiusTech delivered a poster presentation on the FDA compliance landscape (PMA, De Novo, 510k and Pre Cert) and its implication on AI in Healthcare, at the Mayo Clinic AI Symposium earlier this year.
Sponsor Information and Training day Session A1 – Medical Devices: Efficient ...TGA Australia
Overview
Definitions
Regulatory framework
Mandatory and non-mandatory audits
Common issues and how to avoid them
One-page attachment to provide additional information with the application
Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
2. CONTENT
• Definitions
• Classification of devices
• Level of control
• Types FDA regulation
• Establishment registration and device listing
• Premarket notification 510(k)
• Introduction
• substantial equivalence
• Who must submit 510(k)
• content of 510(k)
• when is 510(k) required
• when is 510(k) not required
• De novo classification
2
3. • Pre marketed approval
• introduction
• content of PMA
• review of PMA
• PMA supplement
• types of PMA supplement
• IDE(investigational device exemption)
• Pre marketing requirement
• labelling
• label vs labelling
• Post marketing requirement
• quality system regulation/GMP
• Introduction
• Flexibility to QS regulation
• Quality system pyramid
3
4. • Medical device reporting
• Mandatory medical device reporting
• Complaint file and medical device reporting
• Reporting an emergency
• Searching medical device report
• The final rule
• Importing medical device.
4
5. WHO REGULATES MEDICAL DEVICE
• Australia - Therapeutic Goods Administration (TGA)
• Europe - Certification is obtained from a Notified Body
• USA - Food and Drug Administration (FDA)
• Canada - Health Canada
• China - The State Food and Drug Administration (SFDA)
• Japan - Ministry of Health Labour and Welfare (MHLW)
• Brazil - ANVISA
• INDIA - CDSCO
5
6. FDA
The Food and Drug Administration (FDA or USFDA) is
a federal agency of the united states department of Health and
Human service.
MEDICAL DEVICES
The term “medical devices” includes everything from highly
sophisticated computerized medical equipment down to simple
wooden tongue depressors.
COMPUTERIZED MEDICAL EQUIPMENT -- x-ray machine,
ECG machine, pacemaker etc.
"an instrument, apparatus, implement, machine, implant, in vitro
reagent, or other similar or related article, including a
component part, or accessory which comes under the
pharmacopeia.
6
8. Device Class and Regulatory Controls
1. Class I General Controls
With Exemptions (low risk)
Without Exemptions
2. Class II General Controls and Special Controls
With Exemptions
Without Exemptions
3. Class III General Controls, special control and Premarket
Approval
8
9. ESTABLISHMENT REGISTRATION AND
DEVICE LISTING
Establishments required to list their devices include:
• –manufacturers
• –contract manufacturers that commercially distribute the device
• –contract sterilizers that commercially distribute the device
• –repackagers and relabelers
• –specification developers
• –reprocessors of single-use devices
• –remanufacturers
• –manufacturers of accessories and components sold directly to the end user
• –U.S. manufacturers of "export only" devices
9
Manufacturer must
register their
organisation with
FDA
Submit electronically
or through an US
agent (must provide
all info about agent)
Verify registration
information every
year( october 1-
dec31)
11. PREMARKETED NOTIFICATION
INTRODUCTION
Submitter must compare his
medical device with similar
legally marketed device and
prove substantial equivalence
Submitter submits 510(K) to
FDA before marketing
Submitter receives an order in
form of letter from FDA, which
proves that the device is
substantially equivalent.
• All medical devices must submit premarketed
notification, except:- 1.device for which PMA application
is required
2.device exempted from 510(K)
notification FDA (most class I ).
• For Device with 510(K) submission manufacturer must
receive a clearance order before commercial
distribution
• It takes 90 days to receive clearance or longer typically
130 days ( depends on the information submitted by
manufacturer)
• It should demonstrate that the device to be marketed is
as safe and effective as predicate.
• After 510(K) approval the manufacturer can
manufacture the device without waiting for FDA quality
system inspection, but submitter must be ready for
inspection.
11
12. SUBSTANTIAL EQUIVALENT
• A device is substantially equivalent only if
1.same use as predicate and same technological
characteristic as predicate.
2.same use as predicate but different technological
characteristic as predicate.
• It confirms that safety and effectiveness are adversely effected
by new technological characteristics.
• If FDA determines that the device is not substantially
equivalent, the applicant may:-
Resubmit another 510(K)
Request class I and class II designation through de novo
process
File reclarification submission
Submit a PMA application
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13. WHO MUST SUBMIT 510(k)
• Domestic manufacturer, specification developer, foreign
manufacturer, must submit 510(K) as they are introducing
medical device to:-
USA market for 1st time
Proposing a new and different use for device already in
commercial use
Changing device already in use
Repacker or relabeller who modify or change the labelling
of medical device.
• 510(K) regulation do not specify who must apply for
510(K)
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14. CONTENT OF 510(k)
• There is no 510(k) form
• But these contents must be present
Device name and class
Substantial equivalent comparison to predicate
Indication for use
Description of device
Performance data
Compliance with standard
Labelling, sterilization and packing
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15. WHEN IS 510(k) REQUIRED
15
• When a device is marketed for the 1st time, medical device that
was not marketed before may 28,1976 for these devices 510(K)
is required.
• Propose different use from that of the predicate.
• Change or modification in predicate medical device that affects
the safety and effectiveness
WHEN IS 510(k) NOT REQUIRED
• If unfinished product or components of devices are sold
• If distribute another firms device
• If device is marketed before may 28,1976
• If device is from outside US and the exporter already submitted 510(K),then
the importer need not submit the 510(K).
17. De novo classification
• Also known as automatic class III designation
• For “low risk” devices with no predicate that are found to
be NSE through the 510(k) process
• Submitter must request de novo classification within 30
days of receipt of NSE
• The de novo process has a 60 day review period.
• If FDA grants request the device is permitted to enter
commercial distribution in same manner as 510(K)
clearance
• Device in DE novo can be used as a predicate in future
510(k) submission.
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18. PRE MARKETED APPROVAL
INTRODUCTION
• Mainly applicable for class III devices ( high risk)
• Applicable for class II if device is not substantially
equivalent.
• Most stringent type of device marketing application
• FDA confirms premarketed approval only when it
confirms the scientific evidence to assure that the device
is safe
• FDA requires 180 days to review or longer
• PMA- private license permitting the applicant to market
the device
• FDA notifies applicant that PMA is approved or denied,
the notice is published on internet also.
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19. CONTENT OF PREMARKETED
APPROVAL
• Device description and principle of operation
• Preclinical and clinical studies
• Bibliography of known information
• Manufacturing information
• Professional and patient labelling
REVIEW OF PMA
• TEAM: medical officer, engineer, biologist, statistian,
labelling expert, manufacturing expert will review
premarketed approval
• 45 days to file and 180 days to review
• Advisory committee input is also required
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20. PREMARKETED APPROVAL
SUPPLEMENT
TYPES OF PMA SUPPLEMENT
• 180 DAYS( in depth review)
• SPECIAL PMA SUPPLEMENT- change being affected
• 30 DAYS NOTICE AND 135 DAYS PMA SUPPLEMENT
(manufacturing process and method)
Submission required
for a change affecting
the safety of device
having PMA
Change must meet
the quality system
requirement
21. INVESTIGATIONAL DEVICE
EXEMPTION (collection of data)
• Allows investigational device to be used in clinical study to
collect data (safety and effectiveness)required to support
a pre marketed approval.
• Investigational device exemption is important for device
which do not get clearance using premarketed approval
REQUIREMENTS TO PROCEED WITH
INVESTIGATIONAL DEVICE EXEMPTION
plan approved by institutional review board (IRB) for high
risk
Label stating the device is only for investigational use
Monitoring of study
All records and reports
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22. PREMARKETING REQUIREMENT
LABELLING
LABELLING = LABEL+LITERATURE INFORATION OF
DESCRIPTION
LABEL VS LABELLING
label
Display of written, printed, or graphical matter upon immediate
container
Any information appearing on immediate container must also
appear on the wrapper.
LABELLING
All label and other written, printed or graphite matter upon any
article or accompanying such articles
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23. POST MARKETING REQUIREMENT
QUALITY SYSTEM REGULATION/GMP
INTRODUCTION
Quality system specifies the
requirement of method, facilities and
control for medical device life cycle
Manufacturer must follow quality
system to ensure their product has
all the requirement and specification
Quality system for FDA are also
known as current GMPs
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24. FLEXIBILITY OF QUALITY SYSTEM
REGULATION
All manufacturer
must follow the
same regulation
process for
development
Helps the
manufacturer to
ensure that the
device is safe
Manufacturer must
maintain the
regulation process
without any
compromise
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QUALITY SYSTEM PYRAMID
Quality Manual
Quality Procedures
Detailed Work
Instructions
Records, Forms and
Reports
25. MEDICAL DEVICE REPORTING
• A medical device that cause a death, injury or device
malfunction is required to report FDA
• Helps to detect and correct problem of medical device
MANDATORY MEDICAL DEVICE
REPORTING
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28. COMPLAINT FILE AND MDR
• Complaint file are linked to medical device reporting file
because a complaint must be evaluated to determine if it
is a reportable adverse event
• Complaints may be written, oral, or electronic.
• Manufacture and importer must maintain complaint file.
REPORTING AN EMERGENCY: notify FDA office for crisis
management.
SEARCHING MEDICAL DEVICE REPORT: FDA maintain
the MANUFACTURE AND USER FACILITY DEVICE
EXPERIENCE (MAUDE) database. It contains all reports
from august 1996-present.
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29. MDR – FINAL RULE
Medical device
manufacturer, importer need
not submit annual
certification statement
Domestic distributor need
not submit medical device
report, but must maintain
record of adverse events
Submitters now submit the
report annually instead of
semi-annually
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IMPORTING MEDICAL DEVICE
Foreign manufacturer, manufacture the device that emit
radiation and import to US must comply FDA regulation
(before, during and after importing to US).
Federal agencies are special government organizations set up for a specific purpose such as the management of resources.
CLASS 1 2 3 is based on the risk(low, moderate, high) they pose to consumers by the devices.
Most class 1 and some class 2 devices are exempted from premarket notification 510(k)
All class II medical device must submit even if it do not go through PMA
90% of device are marketed via 510(K).
180 day review begins on date of filing determination.