Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
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?
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Clinical Trial Requirements U.S. vs. EU Similarities and DifferencesRETIRE
The document provides an overview of the key similarities and differences between clinical trial requirements in the United States and European Union. Some of the main differences include: in the US, IND approval is not required to begin a trial but the EU requires CTA approval; the US allows protocol waivers under certain conditions while the EU considers waivers a breach of GCP; and adverse event reporting timelines are generally shorter in the EU. Record keeping requirements for documents and investigational products also differ between the regions.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
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?
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Clinical Trial Requirements U.S. vs. EU Similarities and DifferencesRETIRE
The document provides an overview of the key similarities and differences between clinical trial requirements in the United States and European Union. Some of the main differences include: in the US, IND approval is not required to begin a trial but the EU requires CTA approval; the US allows protocol waivers under certain conditions while the EU considers waivers a breach of GCP; and adverse event reporting timelines are generally shorter in the EU. Record keeping requirements for documents and investigational products also differ between the regions.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
Documentation in Pharmaceutical Industry Part I Tarif Hussian
This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
The document outlines regulations regarding informed consent for biomedical research involving human subjects. It states that informed consent must be obtained from all research participants or their legal guardians. Informed consent documents must include key information such as the study's purpose and procedures, risks and discomforts, benefits, confidentiality protections, and participants' rights to withdraw. Researchers have obligations to fully inform participants and respect their autonomy by ensuring participation is voluntary and without coercion. Special procedures are required for vulnerable populations like children.
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
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
Clinical investigation and evaluation of medical devices and ivd.pptxreechashah2
This document discusses clinical investigation and evaluation of medical devices and in vitro diagnostics (IVDs). It defines medical devices and IVDs, describes their classification systems, and explains when clinical investigations and evaluations are needed. Clinical investigations generate safety and performance data, while evaluations assess existing data. The document outlines ethical considerations and describes the stages and reports involved in clinical investigations and evaluations.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The document discusses data and safety monitoring boards (DSMBs), which regularly review accumulating data from ongoing clinical trials to monitor safety and scientific validity. A DSMB is typically appointed by the trial sponsor. The document outlines factors in determining if a trial needs a DSMB, how DSMBs are composed, their responsibilities like monitoring safety and effectiveness, and how they make recommendations to sponsors. Not all trials require independent external DSMBs, but all should have a data safety monitoring plan to protect participants.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
This document discusses EU regulations regarding clinical investigations for medical devices. It provides definitions for key terms like clinical data, clinical use, sufficient clinical evidence, and clinical investigation. It explains that premarket clinical investigations are often required for implants, high-risk devices, and those extending intended use, while postmarket studies follow CE marking to answer safety or performance questions. Clinical investigations must meet requirements like having a protocol, informed consent, qualifications of investigators, and reporting adverse events. The conclusion is that the EU demands higher clinical evidence throughout a product's lifecycle compared to other regions.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
Documentation in Pharmaceutical Industry Part I Tarif Hussian
This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
The document outlines regulations regarding informed consent for biomedical research involving human subjects. It states that informed consent must be obtained from all research participants or their legal guardians. Informed consent documents must include key information such as the study's purpose and procedures, risks and discomforts, benefits, confidentiality protections, and participants' rights to withdraw. Researchers have obligations to fully inform participants and respect their autonomy by ensuring participation is voluntary and without coercion. Special procedures are required for vulnerable populations like children.
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
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
Clinical investigation and evaluation of medical devices and ivd.pptxreechashah2
This document discusses clinical investigation and evaluation of medical devices and in vitro diagnostics (IVDs). It defines medical devices and IVDs, describes their classification systems, and explains when clinical investigations and evaluations are needed. Clinical investigations generate safety and performance data, while evaluations assess existing data. The document outlines ethical considerations and describes the stages and reports involved in clinical investigations and evaluations.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The document discusses data and safety monitoring boards (DSMBs), which regularly review accumulating data from ongoing clinical trials to monitor safety and scientific validity. A DSMB is typically appointed by the trial sponsor. The document outlines factors in determining if a trial needs a DSMB, how DSMBs are composed, their responsibilities like monitoring safety and effectiveness, and how they make recommendations to sponsors. Not all trials require independent external DSMBs, but all should have a data safety monitoring plan to protect participants.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
This document discusses EU regulations regarding clinical investigations for medical devices. It provides definitions for key terms like clinical data, clinical use, sufficient clinical evidence, and clinical investigation. It explains that premarket clinical investigations are often required for implants, high-risk devices, and those extending intended use, while postmarket studies follow CE marking to answer safety or performance questions. Clinical investigations must meet requirements like having a protocol, informed consent, qualifications of investigators, and reporting adverse events. The conclusion is that the EU demands higher clinical evidence throughout a product's lifecycle compared to other regions.
Learn more about the commercial context of clinical trials, and how to leverage international networks to provide input into clinical trial designs that will generate value beyond regulatory approval, and provide supporting data to cause the adoption of medical devices.
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.
The document discusses the FDA's regulatory pathways for medical devices. The FDA uses a risk-based classification system to categorize devices as Class I, II, or III based on risk, with Class III devices posing the highest risk. Class I devices face the fewest regulatory requirements while Class III devices require a rigorous premarket approval process. The key pathways are 510(k) clearance for Class II devices and premarket approval (PMA) for Class III devices. The FDA aims to evaluate devices throughout their lifecycle from premarket through postmarket surveillance to ensure safety and effectiveness.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
This document discusses challenges in using Bayesian and decision analysis approaches for regulating medical products. It notes issues like subjectivity in choosing priors, controlling type I error rates, and the need for legal availability of prior information. Promising areas for using prior information include pediatric trials, rare diseases, safety, and expedited access programs. Bayesian adaptive designs allow interim analyses to optimize sample size and model-based likelihoods. Decision analysis can make benefit-risk determinations more explicit through tools like influence diagrams and considering patient preferences. The highest value of Bayesian approaches is in accounting for external evidence, using flexible trial designs, modeling likelihoods, developing transparent decision rules based on factors like medical need and patient perspectives.
The document discusses liquid biopsies and next generation cancer molecular diagnostics. It summarizes that OncoCyte Corporation is focused on developing diagnostic tests for early cancer detection using liquid biopsies, with an initial focus on tests for lung cancer. Key points include that lung cancer diagnostics represents a large market opportunity and that OncoCyte's preliminary lung cancer diagnostic test shows strong performance in clinical trials with high sensitivity and specificity. The test has the potential to reduce risky follow-up procedures for patients and provide significant healthcare cost savings.
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...Levi Shapiro
Presentation by Michael imhoff about the upcoming Medical Device Regulation (MDR) in the EU. Includeds compliance with the General Safety and Performance Requirements. Demonstration of conformity with the general safety
and performance requirements in clinical
evaluation. Clinical evaluation with evidence for safety
and performance of the medical device. Assessment of side effects and the acceptability of the risk-benefit-ratio, based on clinical data. MDR is not a health technology assessment for payers. Results of the clinical evaluation should be documented
in a clinical evaluation report (CER).
The regulation of medical devices in AustraliaTGA Australia
The regulation of medical devices in Australia involves classifying devices based on their intended use and risk level. Higher risk devices undergo more rigorous assessment procedures to ensure they meet essential safety and performance principles before being approved for market. Ongoing monitoring is also conducted after devices enter the market to protect public health. The TGA regulates medical devices to confirm they are suitable for their intended purpose and that their benefits outweigh any risks when used correctly.
Where do clinical evaluation and clinical investigation intersectI3CGLOBAL
Clinical Evaluation is the process of collecting and assessing all clinical data related to a device and evaluating whether sufficient clinical evidence exists to support conformity with regulatory requirements. The clinical investigation is often the most important evidence needed to prove your medical device is ready for market.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Presentation by David Farber, FDA Life Science Partner at King & Spalding, about US Reimbursement.
I. Introduction
• II. FDA Approval vs. Reimbursement
• a. Different Standards
b. Clinical Evidence Needed
• III. The Three Keys to Reimbursement
A. Coverage
B. Coding
C. Payment
• IV. What’s New for 2019
• V. Reimbursement for MedTech AI Solutions
• VI. Tips for Successful Reimbursement
This document discusses quality control procedures for surgical pathology services. It defines key terms like quality assurance, quality control, and quality improvement. It then outlines the phases of quality control including pre-analytic, analytic, and post-analytic phases. The document provides details on approaches to quality control, including monitoring specimen handling and processing, diagnostic accuracy and turnaround times, pathology reporting standards, and ensuring diagnostic findings are integrated with ancillary study results.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
A clinical investigation is defined as “any systematic investigation or study in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of medical device.”
The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.
One of the purposes of a clinical investigation could be to establish and verify clinical safety, meaning to understand how to prevent and reduce risks, errors and harm that can happen to patients and personnel, such as doctors and nurses. The cornerstone of all clinical research is to provide a continuous improvement of treatment methods based on the understanding and learning from errors and adverse events detected.
Furthermore, the purpose of a clinical investigation can also be to establish and verify the performance of a device. This means checking the ability (or capability) of a device to perform as planned. This is done by looking at the technical, functional, or even diagnostic characteristics of the device. It needs to be verified whether it enables the manufacturer to achieve the intended purpose of the device and that it will lead to clinical benefits for patients.
Another purpose is to establish and verify clinical benefits, which is in its essence looking at the positive impact a device can have on the health of an individual. It is expressed in terms of a meaningful and measurable patient-focused outcome.
And finally, in the setting of a clinical investigation, side effects play a special role. One of the goals of a clinical investigation can be to gather additional information on the known side effects and to identify previously unknown side effects.
The overall purpose of a clinical investigation can be summed up to say that it is meant to translate scientifically tested innovations into clinical practice to provide patients with new (or improved) treatments.
A properly conducted clinical investigation, including compliance to the clinical investigation plan and local laws and regulations, ensures the protection of subjects, the integrity of the data and that the data obtained is acceptable for the purpose of demonstrating conformity to the Essential Requirements.
ISO 14155 outlines good clinical practice for clinical investigations of medical devices.
Thank you for the summary. Here are a few key points I noticed:
- GCP provides an international quality standard for clinical research to protect participants and ensure reliable data.
- It has evolved in response to past abuses and aims to harmonize standards across countries/regions.
- Key roles include sponsors to design/manage studies, principal investigators to oversee local research, and staff to conduct study procedures.
- Regulations like the Code of Federal Regulations codify GCP principles to facilitate compliance.
Overall this helps explain the purpose and scope of Good Clinical Practice as an important framework in clinical research. The summary effectively distills the main points from the lengthy document.
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
This document discusses clinical data management (CDM) which aims to ensure valid study data through collection, integration, and quality control of data. CDM involves developing data management plans, standard operating procedures, electronic case report forms, and using clinical data management systems. Key roles in CDM include clinical data managers who oversee data collection, validation, and storage in compliance with regulations. International guidelines like ICH-GCP provide principles for ethical and scientific conduct of clinical trials.
Similar to Clinical Trial Requirements Medical Devices 27 dec2018 (20)
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
Simplifying study designs and statistical models for new dose & dosage forms ...Bhaswat Chakraborty
This document discusses study designs for evaluating the bioequivalence of new drug doses and dosage forms through pharmacokinetic or pharmacodynamic studies. It covers topics such as parallel vs. crossover study designs, sample size calculations, evaluating modified release dosage forms, and considering food effects and non-linear pharmacokinetics. The document also discusses using in vitro studies like dissolution testing and permeation studies to establish bioequivalence for some drug products like topical creams when in vivo studies are challenging.
Equivalence approches for complex generics DIA 11 april 2019 Bhaswat Chakraborty
This document discusses approaches for demonstrating bioequivalence of complex generic drug products. It begins with an overview of the pre-ANDA program for complex generics, including product development meetings, pre-submission meetings, and mid-review cycle meetings. It then discusses specific challenges and considerations for complex active ingredients like peptides, as well as example complex drug products like sevelamer carbonate tablets and ophthalmic ointments and suspensions. The document emphasizes that demonstration of bioequivalence for complex generics often requires alternative approaches like in vitro studies and physiochemical characterization due to challenges with clinical endpoint studies.
Writing Science papers for for publication requires something more thatn creativity. Target journals, content organization, wrting style, elegance and referencing are equally important.
Multidisc review of NDAs and BLAs nipicon 2018 Dr. ChakrabortyBhaswat Chakraborty
NDAS and BLAs cannot be authoritatively reviewed these days until experts from different disciplines act together like a team. This presentation give some foundational points and an illustrative example in that regard.
Teaching by stories, anecdotes and historical facts sept 25 2018Bhaswat Chakraborty
Many difficult principles in science and humanities can be taught best by a story (of its discovery), by an anecdote or some historical facts about them.
Orientation and Adaptation for Post-Graduate Pharmacy ProgramsBhaswat Chakraborty
PG Pharmacy programs are more focused and professionally oriented than the undergraduate counterpart. Many soft skills are required along with the curricular competence for excellence at the PG level.
Scientific integrity calls for some basic originality. Plagiarism can destroy this original creativity and ideation. This presentation defines plagiarism (stealing from others' works) and some of the creative and systematic remedies.
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
There are several dimensions in Pharmaceutical ethics -- Practice-, research- and community oriented. This presentation mainly deals with Clinical research oriented Ethics.
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
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2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
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Clinical Trial Requirements Medical Devices 27 dec2018
1. Clinical Trial Requirements for Market
Approval of Medical Devices
Prof. (Dr.) Bhaswat S. Chakraborty
Emeritus Professor, Institute of Pharmacy, Nirma University
Former Sr.VP &Chair, R&D, Cadila Pharmaceuticals
Former Director, Biopharmaceutics, Biovail, Toronto
Former Sr. Efficacy & Safety Reviewer, TPD (Canadian FDA), Ottawa
Presented at the ACIES Plus and International Conference on Med-
Tech Innovation for Primary Health Care, IIPH Gandhinagar, India,
December 27, 2018
2. From Clinical point of view, they
are of different risk classes
requiring different clinical
efficacy & safety evidence
3.
4.
5. Two Official Documents Aiding Market
Authorisation
• Medical Devices Rules 2017, published by
Indian Ministry of Health and Family
Welfare and a subsequent recent Guidance
document by Indian Pharmacopoeia
Commission clarify requirements for
approval of medical devices in India.
• Among various aspects, Quality and Efficacy
& Safety requirements for approval of
medical devices have been stated.
• None of the official guidance documents of
India describes the clinical trials (CTs) data
requirement in details.
Medical Devices Rules 2017
Guidance by IPC
6. Classification
• Medical devices are heterogeneous devices that
have been first classified into in vitro diagnostic
devices and devices other than in vitro.
• In India, in accordance with global task force
findings, the devices have been further classified
into four categories – A, B, C and D based on the
risks associated with their use with A presenting
lowest and D highest of risks.
• The IPC Guidance document lists a few hundred
dvices along with its classification. Please refer to
it before assuming a classification. For example,
• Rotavirus, pneumonia and H. Pylori antibody test
reagents and kits are Class B;
• Most of the blood grouping and tissue typing reagents
and kits are Class C;
• HLA, HIV, HBV & HCV test reagents and kits are class D
In vitro and
other than
in vitro
diagnostics
Low Risk
Class A
Low Moderate
Risk Class B
Moderate High
Risk Class C
High Risk
Class D
7. Clinical Investigations: MD Rules 2017
• Although the medical devices rules 2017 does not give any details of data
requirements for clinical investigations medical devices, they do mention
and give at least three clear indications:
• 1. A pilot clinical investigation meaning a clinical study may have to be carried out
for the first time in human beings
• A pivotal clinical investigation meaning a confirmatory clinical trial based on the
data emerging from pilot clinical trial [may have to be carried out for Class C & D]
• 3. Medical devices requiring clinical trials but claiming substantial equivalence
cannot be marketed without official approval
8. A 510(k) Type CT to Establish Substantial Equivalence
• Non-inferiority CT with a well-
defined non-inferiority margin
• Equivalence and non-inferiority are
similar but not the same thing….most
510(k) ‘substantial equivalence’ trials
are technically ‘non-inferiority’ trials
• One-sided or uni-directional statistical
criteria
• Sometimes a bioequivalence trial of a
MD is possible
9. Clinical Trial(s) Data Requirement
• The Global Harmonization Task Force (GHTF) was established in 1992
(Australia, Canada, the EU, Japan & US); aim of the GHTF is to
harmonize the regulatory systems around the globe
• US or EU MD CT guidances are developed and are of great help
• US FDA classifies the MDS as Class I (general controls); Class II (special
controls); and Class III (pre-market approval – PMA)
• Certain Class I, II & III can enter the market through 510(k) of the ACT – once
determined substantially equivalent to a legally marketed device that does not
require PMA
• PMA requires complete evidence of efficacy & safety; often pivotal CTs for
Class III MDs
• Class I & II are exempt from the above II but not from general controls
10. Non-Inferiority CTs for Substantial Equivalence
• Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-
inferiority designs
• By S. Raymond Golish https://doi.org/10.1186/s13063-017-2032-2
• Background: Background: The United States Food and Drug Administration (FDA) reviews class III
orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this
study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical
trials, and the subjective factors affecting the interpretation of clinical trial data.
• Methods: Meeting materials were collected from FDA electronic archives and notes were made
regarding the device-type and subsequent approval and recall, the design of pivotal clinical trials,
and issues of trial interpretation debated during panel deliberations.
• Results: Of the 23 pivotal trials, 20 (87.0%) were randomized controlled trials (RCTs), consisting of
13 (65.0%) non-inferiority trials and 7 (35.0%) superiority trials, and all RCTs were two-arm trials. At
panel, the most commonly debated issues were related to the design and interpretation of non-
inferiority trials.
• Conclusions: A broad array of device types is reviewed by the FDA. The
predominance of two-arm non-inferiority trials as pivotal studies indicates that
the nuances of their design and interpretation are commercially important.
11. CTs for Medical Devices: Key Points
• Trial Objectives
• Clinical endpoints consistent with primary trial objectives
• Pilot or Feasibility Study
• Evidence to support trial
• Study Population
• Control and Experimental
• Sample size (usually N ≤ 1000 for MD Pivotal RCTs)
• Statistically justified by effect size, anticipated variability & desired α and
power
• Robust, appropriate outcome variables
• Minimizing effects of confounding variables
12. CTs for Medical Devices: Key Points..
• Trial Design
• Parallel, crossover?
• Statistical plan
• Follow up
• Missing Data Handling
• Handling plan
• Adverse Events
• Interim Analysis, DMC
• Alpha spending
• Stop or go rules
• Efficacy and Secondary Endpoints
• Efficacy endpoints are often part of primary objectives of an MD
13. Sequence of Events
• Patient requires a device
• Patient eligible for inclusion in the
trial
• Clinician willing to accept
randomization
• Patient consent is obtained
• Patient formally entered on the trial
• Device assignment obtained from
the randomization list
• On study forms completed
13
• Trial commences
• Clinical monitoring commences
• Central collection of all data
• Query generation & cleaning
• Portion (1/3 or 1/2) of data
complete for Interim Analysis
• Continuation of rial
• Cleaning of data etc.
• Trial Complete
• Follow up
14. Case Study Example: PMA Number P150033
Micra Transcatheter Pacing System
(Implantable Cardiac Pacemaker (IPG))
INDICATION FOR USE
• The Micra Transcatheter Pacing System is
indicated for use in patients of:
• symptomatic paroxysmal or permanent
high-grade AV block in the presence of
Atrial Fibrillation (AF)
• symptomatic paroxysmal or permanent
high-grade AV block in the absence of AF,
as an alternative to dual chamber pacing
• symptomatic bradycardia-tachycardia
syndrome or sinus node dysfunction
Rate-responsive pacing is indicated to provide
increased heart rate appropriate to increasing
levels of activity.
15. Inclusion Criteria
Criteria Rationale
Subjects who have a Class I or II indication for
implantation of a single chamber ventricular
pacemaker according to ACC/AHA/HRS 2008
guidelines and any national guidelines1,2
Study will be evaluated in the standard
patient population that is actually
indicated for the device under
evaluation.
Subjects who are able and willing to undergo the study
requirements and are expected to be geographically
stable for the duration of the follow-up.
Ensure ascertainment of data required
for clinical evaluation.
Subjects who are at least 18 years of age (or older, if
required by local law).
Ensure age is appropriate to provide
informed consent.
16. Micra Case Study: Clinical Endpoints – Effectiveness
• The primary effectiveness objective was to demonstrate the percentage of
subjects with an adequate pacing capture threshold at 6-months post-implant
exceeds 80% (i.e. the lower two-sided confidence interval must exceed 80%).
• An adequate pacing capture threshold (PCT) is defined as:
1. A 6-month PCT ≤ 2V at a pulse duration of 0.24 ms and
2. An increase in PCT from implant to 6-months ≤ 1.5 months (0.24 ms pulse width)
• Hypothesis
• H0: π ≤ 80%, versus
• Ha: π > 80% where π is the percentage of successfully implanted subjects with an adequate
6-month pacing capture threshold (PCT).
17. Micra Case Study: Clinical Endpoints – Safety
• The primary safety objective was to demonstrate that the freedom from major
complications related to the Micra system and/or procedure at 6-months post-
implant is greater than 83% (i.e., the lower boundary of the two-sided 95%
confidence interval must be greater than 83%).
• Hypothesis
• Ho: S(6 months) ≤ 83%, versus
• Ha: S(6 months) > 83% where S(6-months) is the freedom rate at 6-months (183 days) post-
implant for major complications related to the Micra system and/or procedure.
18. Micra Case Study: Efficacy Performance Requirement
• The lower boundary of the two-sided confidence interval for the
percentage of subjects with an adequate 6-month pacing capture
threshold must be greater than 80% for the null hypothesis to be
rejected.
• Interim analysis α adjustment:
• The null hypothesis could be rejected if the nominal P-value is less than
0.0067 at the first interim analysis.
19. Micra Case Study: Efficacy Results
Subjects1 Subjects
with
Adequate
6- Month
PCT
% Subjects
with
Adequate 6-
Month PCT
98.66% CI2 Performance
Goal
Nominal
One-
sided P-
value3
297 292 98.3% (95.4%,
99.6%)
80% <0.0001
1. Of the 297 subjects who contributed to the primary efficacy analysis, 292 (98.3%) had
an adequate 6-month PCT, meaning they had a 6-month PCT no greater than 2.0V
and had a rise in PCT from implant to 6-months of no more than 1.5V.
2. This observed percentage of subjects with an adequate safety margin was greater
than the pre-specified goal of 80% since the nominal one-sided P-value was lower
than the nominal alpha level of 0.0067
20. Micra Case Study: Safety Results
• There were 28 major complications in 25 subjects related to the Micra system or
procedure as determined by the CEC occurring in the 725 subjects with a Micra
implant attempt during a total of 3124.1 months of follow-up.
• The Kaplan-Meier estimate for the freedom from major complications related to Micr
system or procedure at 6-months (183 days) post-implant was 96.0% (98.66% CI:
93.3% - 97.6%).
• This was higher than the pre-specified performance criterion of 83% (P<0.0001). Since
the p-value associated with this test was lower than the p-value required to reject the
null hypothesis at the first interim analysis (0.0067).
• The null hypothesis was rejected and the primary safety objective was considered
met.