REGULATORY AFFAIRS &

INTELLECTUAL PROPERTY
(Medical devices and in-vitro
Diagnostics)

BY:
SHIVANI TANWAR

N.S.D.C
 AGENDA
DAY 1
1. Introduction to the Life Sciences Industry and Applicable Regulations
2. Fundamentals of Research and Development in Medical Devices and In-vitro Diagnostic Devices (IVD)
3. Development of Technical Dossier guidelines for medical devices and In-vitro Diagnostic Devices (IVD)

DAY 2
4. Submission of Technical Dossier as per the Regulatory Guidelines
5. Managing the Regulatory Affairs for Medical Devices and In-vitro Diagnostic Devices (IVD)
6. Managing Intellectual Property Rights for Medical Devices and In-vitro Diagnostic Devices
7. Coordination with Manager, Teammates and Auditors and Display Sensitivity Towards Genders and
People with Disabilities

DAY 3
8. Comply EHS Rules at Workplace
9. Employability Skills
10.Entrepreneurial Activities to Start and Run the Business Operations
11. Manage the Critical Documents for Business Activities and Statutory and Regulatory Compliance

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 What is A Medical Device?

 As per US FDA, Section 201(h) of the Food, Drug & Cosmetic  And does not achieve its
Act (FD&C Act) defines a Medical Device as: primary intended purposes
 An instrument, apparatus, implement, machine, contrivance, through chemical action
implant, in vitro reagent, or other similar or related article, within or on the body of
including a component part or accessory which is: man or other animals and
• recognized in the official National Formulary, or the United which is not dependent
States Pharmacopoeia, or any supplement to them, upon being metabolized for
• intended for use in the diagnosis of disease or other the achievement of its
primary intended purposes.
conditions, or in the cure, mitigation, treatment, or
 The term "device" does not
prevention of disease in man or other animals, or include software functions
• intended to affect the structure or any function of the body excluded pursuant to section
of man or other animals 520(o).
 Examples: Stents, implants, pacemakers, syringes etc.

N.S.D.C
 What is An In- vitro Diagnostics (IVDs)?

 As per US FDA, Food, Drug & Cosmetic Act (FD&C Act) defines a In-vitro Diagnostics
as:
 Reagents, instruments, and systems intended for use in the diagnosis of disease or
other conditions.
 Collect, prepare, and examine specimens taken from the human body
 Can be used in a laboratory, health professional setting or at home

 Examples: Home Pregnancy Test, Glucose Test Strip

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 Life Sciences Industry and Its Sectors
Life sciences have applications in medicine, health, pharmaceutical, medical devices, food science and agriculture
industries. Usually, ‘Life Sciences’ can be considered as all sciences that have to do with ‘organisms’, like animals, human
beings and plants.

• Formulations
• API/ Bulk Drugs
Pharmace • AYUSH Drugs
uticals • Cosmetics
• Nutraceuticals

Biotechnol • Biotech products like vaccines, serums,

biofertilizers etc.
ogy • Medical Devices & IVDs

• Drug Discovery and Pre-clinical

• Product Development
R&D • Clinical Research
Services • Other R & D Services

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 Life science Industry – India Context

 India is one of the fastest growing Life Sciences (LS) markets in the world. The LS sector in the country is
poised to see multi-fold growth by 2030 led by fast-increasing population, rising life expectancy, a strong
industrial base and inclusive government initiatives.
 India is now known as the "Pharmacy of the World'' since the country is a major producer of affordable
generic medicines and has emerged as a supplier of a significant portion of the global market’s need for
generic medicines.
 India’s pharmaceutical industry, ranked third worldwide in terms of volume, is the largest supplier of
generic drugs and is well-regarded for the role it plays in making high-quality medicines and vaccines
affordable to the global population. Fueled by domestic and foreign demand, the sector continues to
grow; currently a US$50 billion industry, optimistic forecasts project the Indian pharmaceutical industry
could reach US$150 billion within a decade.
 Due to its affordable and innovative inventions in this field, India has emerged as an exporter of many
devices and medicines that have helped improve Global health conditions.
 The life sciences sector demands a highly skilled and specialized workforce. Attracting and retaining top-
tier talent is a challenge that must be addressed strategically.

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 Life science Industry – India Context

 Clinical Trials and Research

Clinical trials have increased in India due to its diverse patient population and lower costs.
Thus, it becomes easier to conduct clinical trials and research in India. The country also
contributes to global research through collaborations and partnerships with international
pharmaceutical companies.

 Medical Devices and Diagnostics

The medical devices and diagnostics sector, driven by increasing healthcare awareness and
demand, is also rising. India is becoming a manufacturing hub for medical devices, serving
both domestic and international markets. The medical devices sector continues to innovate,
producing advanced technologies like implantable devices, and wearable health tech making
health care more accessible even to the common masses. Various devices have been
launched that enable patients to measure their vitals without assistance from trained
professionals, making healthcare easier and more accessible.
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 Regulatory Affairs and Intellectual Property

 Comprehensive understanding of RA and Intellectual Property (Patents, Trademarks,

Copyrights etc.) plays a crucial role in Life science Industry:

Safeguarding Building Brand Protecting creative

Innovation (Patents) Awareness expressions
(Trademarks) (Copyrights)

Ethical
Preserving
Considerations
Confidentiality
(Safety and Well-
(Tradesecrets)
being of Patients)

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 Global Regulatory Authorities and Global Standards
ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for
Human Use)
WHO (World Health Organization)

USA: Food and Drug Administration

European Union: European Medicine Agency (EMA)
United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA)

Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Australia: Therapeutic Goods Administration (TGA)
India: Central Drugs Standard Control Organization (CDSCO)

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 Regulations and Legislations
 Good Manufacturing Practices (GMP): To ensure that products produced have the
same consistency and are controlled according to quality standards. These practices
concern facility design, equipment validation, process control, cleanliness, and
record keeping.

 Good Laboratory Practices (GLP): These pertain to non-clinical laboratory studies,

ensuring accuracy and reliability and the integrity of data generated while testing
pharmaceuticals and medical devices.

 Good Distribution Practices (GDP): The regulations address the proper storage,
distribution, and transportation of pharmaceutical products like medical devices to
maintain their quality and integrity. Distribution is key in this industry because
machines can be compromised during movement, reducing performance.

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 Good Practices in Production Operations
 Process Validation: ensures manufacturing processes produce consistent products of desired quality and
characteristics.
 Change Control: To manage and document any changes to processes and equipment and assess their
impact on product quality and safety to ensure consistent product quality.
 Batch Record Keeping: Maintaining comprehensive records for each batch of products that are
manufactured. Examples production steps, test results, deviations, and corrective actions.
 Cleaning Validation: Proper verification of equipment used in production is essential as it has to be
determined whether the equipment has been adequately cleaned or not to prevent cross contamination
and ensure product safety.
 Personnel Training: It is crucial to ensure that all personnel involved in production operations are trained
in GMP, safety practices, and all required procedures.
 Environmental Monitoring: Monitoring and controlling environmental conditions in production areas to
prevent contamination and maintain product quality.
 Documentation Management: The next step is to ensure document control processes for creating,
reviewing, approving, and archiving production-related documents.
 Quality Control Testing: Most importantly, conducting thorough testing and analysis is essential to ensure
that products meet predetermined specifications and quality standards.

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Job Roles Requirements

- Manufacturing Department - Regulatory Knowledge

- Quality Control, Quality Assurance - Legal and Intellectual Property Acumen
- Regulatory Affairs - Documentation Skills
- Research and Development - Research and Analytical Skills:
- Sales and Marketing - Ethical Awareness
- Consulting Services - Attention to Trends
- Regulatory Compliance Startups - Technical Aptitude
- Intellectual Property Management - Communication Skills
- Regulatory Training and Education - Problem-Solving
- Innovation and Product Development - Negotiation Skills
- Regulatory Software Development - Collaboration and Teamwork
- Time Management
- Compliance Auditing and Due Diligence
- Global Market Entry Assistance - Continuous Learning

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 Questainnaire

• Which regulatory body in India oversees the life sciences industry?

a. FDA
b. CDSCO
c. EMA
d. WHO

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 Questainnaire

• What does GMP stand for in the context of life sciences

manufacturing?

a. Good Marketing Practices

b. General Manufacturing Principles
c. Good Manufacturing Practices
d. General Marketing Protocols
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 Questainnaire

• What is the primary responsibility of an Associate in Regulatory

Affairs and Intellectual Property?

a. Manufacturing supervision
b. Ensuring product quality
c. Compliance with marketing standards
d. Navigating regulatory requirements

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 Questainnaire

• Which global organization plays a key role in international health

regulations?

a. UNICEF
b. WHO
c. NATO
d. GATT

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 Questainnaire

• What is the significance of GDP in the life sciences manufacturing

context?

a. Gross Domestic Product

b. Good Distribution Practices
c. General Development Procedures
d. Global Drug Production

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 Biological Engineering and Biotechnology in Medical and IVDs

Tissue Biomechanics:
Biological
Engineering: analyze the
Biological Enables the engineers design Develop mechanics of
engineering design and and select strategies to biological tissues
focuses on the development biocompatible create tissue and organs to
application of of products biomaterials constructs and design prosthetics,
engineering that solve suitable for bioengineered orthopaedic
principles to complex medical device organs for implants, and
biological medical components, transplantation, wearable devices
systems challenges implants, and wound healing, that enhance
and regenerative mobility and
IVD surfaces. functionality
medicine.

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 Biotechnology

modify the genetic Biotechnology Biotechnology is key

Genetic Engineering

Cell Culture and

Fermentation

Molecular Diagnostics
makeup of cultures cells and in developing IVDs
organisms to microorganisms to based on nucleic
produce produce acid amplification
therapeutic biopharmaceuticals, techniques, such as
proteins, enzymes, enzymes, and other PCR. Which helps
and biomolecules bioactive substances detect genetic
used in medical for medical markers, pathogens,
devices and applications. and mutations.
diagnostics.

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 Biotechnology

Biotechnologists Biotechnology Used for sample

Immunoassays

Point-of-Care Devices

Microfluidic Devices
can utilize contributes to handling, mixing,
antibodies and developing separation, and
antigen-antibody portable and rapid analysis, enabling
interactions to diagnostic devices compact and
create diagnostic that can be used at efficient diagnostic
tests that detect the point of care platforms.
specific biomarkers for timely
and analytes in diagnosis and
patient samples. treatment.

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 Bioinformatics (Medical Devices and IVDs)

 Bioinformatics uses computational tools and data analysis to extract meaningful insights
from biological data. In medical devices and IVDs:
 Data Interpretation: Bioinformatics tools analyze complex genomic, proteomic, and
metabolomic data to aid diagnosis, personalized medicine, and treatment monitoring.
 Genomic Diagnostics: Bioinformatics also plays a crucial role in interpreting genetic
information obtained from sequencing technologies, enabling the identification of
disease-associated mutations and variations.

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Production of Medical and In vitro Diagnostic Devices
Materials Science and Biomaterials

Microfabrication and Nanotechnology

Sensor Technology

Biotechnology and Molecular Biology

Signal Processing and Data Analysis

Quality Control and Regulatory Compliance

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 Production of Medical and In vitro Diagnostic Devices

 Interdisciplinary Collaboration:
Production of medical devices and IVD requires close collaboration between scientists,
engineers, clinicians, and regulatory experts that ensures the devices are not only
scientifically sound but also practical, effective, and compliant with regulatory requirements.
 Regulatory Focus:
To ensure the efficacy and safety of medical devices globally, associates must have a
comprehensive understanding of regulatory compliances.
 Sustainability and Environmental Impact:
Exploring and incorporating the use of eco-friendly materials, implementing recycling
initiatives within manufacturing processes, embracing energy-efficient manufacturing
processes, conducting comprehensive life cycle assessment of medical devices, and
encouraging suppliers to adhere to green and sustainable practices are some of the
initiatives to engage in a culture of responsibility towards the environment.

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Documentation and Dossier Preparation

Licensing and Facilitating the

Regulatory Global Market
Approval Access

Compliance Legal
and Post- Compliance
Market and
Surveillance Accountability

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RA Role and Responsibilities

- Knowledge of Global Medical Devices Regulations

- Product development, manufacturing, and quality control documentation
- Product Classification and Categorization
- Preparation of Regulatory Submissions
- Quality System Documentation
- Intellectual Property Protection
- Labelling and Instructions for Use
- Change Control and Documentation Updates
- Regulatory Audits and Inspections
- Post-Market Surveillance and Reporting
- Collaboration and Communication
- Record Keeping and Archiving

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 Questainnaire

• What is the primary purpose of a dossier in the context of medical

devices and IVDs?

a. Marketing
b. Regulatory approval
c. Quality control
d. Intellectual property protection

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 Questainnaire

• What is the role of an Associate in Regulatory Affairs and

Intellectual Property in the life sciences industry?

a. Device manufacturing
b. Quality assurance
c. Legal compliance
d. All of the above

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 Questainnaire

• Why is thorough documentation crucial in the production of

medical devices and IVDs?

a. To ensure safety and efficacy

b. To protect intellectual property
c. To expedite regulatory approval
d. All of the above

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 Questainnaire

• Which disciplines are integrated into the fundamental science of

medical device and IVD development?

a. Biology
b. Chemistry
c. Physics
d. All of the above

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 Questainnaire

• What is the significance of compliance with current regulations in

the field of medical devices and IVDs?

a. Ensures market access

b. Enhances product quality
c. Fulfills legal requirements
d. All of the above

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Development of Technical Dossier guidelines
for medical devices and In-vitro Diagnostic
Devices (IVD)
 Is My Product A Medical Device?

 As per US FDA, Section 201(h) of the Food, Drug & Cosmetic  And does not achieve its
Act (FD&C Act) defines a Medical Device as: primary intended purposes
 An instrument, apparatus, implement, machine, contrivance, through chemical action
implant, in vitro reagent, or other similar or related article, within or on the body of
including a component part or accessory which is: man or other animals and
• recognized in the official National Formulary, or the United which is not dependent
States Pharmacopoeia, or any supplement to them, upon being metabolized for
• intended for use in the diagnosis of disease or other the achievement of its
primary intended purposes.
conditions, or in the cure, mitigation, treatment, or
 The term "device" does not
prevention of disease in man or other animals, or include software functions
• intended to affect the structure or any function of the body excluded pursuant to section
of man or other animals 520(o).
 Examples: Stents, implants, pacemakers, syringes etc.

N.S.D.C
 Is My Product An In- vitro Diagnostics (IVDs)?
 As per US FDA, Food, Drug & Cosmetic Act (FD&C Act) defines a In-vitro Diagnostics
as:
 Reagents, instruments, and systems intended for use in the diagnosis of disease or
other conditions.
 Collect, prepare, and examine specimens taken from the human body
 Can be used in a laboratory, health professional setting or at home

 Examples: Home Pregnancy Test, Glucose Test Strip

 As per 21 CFR21 CFR 3.2(e), Combination products are therapeutic and diagnostic
products that combine drugs, devices, and/or biological products.
 Examples: Examples: Drug Eluting Stent, Heparin Coated Dialysis Catheter, First-Aid
Kit with a Drug.

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 Steps to Determine if a Product is A Medical Device?

Step 1: Determine if your product meets the definition of a medical device

per Section 201(h) of the Food, Drug & Cosmetic Act.
Step 2: Determine if an appropriate product classification exists for your
product.

Know your product?

What is the intended use of your product?

How does your product function?
What claims do you intend to make?

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Classificatio Based on device description and intended use:
n of Medical • Determines extent of regulatory control
Device • Class I, II, or III (increases with degree of risk)

*More common submission requirement of this Class

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Regulatory Controls: Requirements that apply to a product area
(product code)
• Labelling
• Medical Device Reporting
• Establishment Registration
General Controls (apply to all • Device listing
• Quality System
medical devices) • Adulteration
• Misbranding
• Specific to Class II devices
• Not common
Special
• Usually for well-established device types
Controls • Examples: Design; characteristics or
specifications; Testing; Special Labeling and
Guidance documents

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 Steps to Get a New Product to Market
1. Identify Product Description and its intended use and indications for use
2. Verify that the Product is a Medical Device
3. Identify Regulatory Classification – Classification generally indicate regulatory
pathway (premarket submission type) required for the device.

4. Develop valid scientific evidence (if required) for safety and evidence
5. Prepare Premarket Submission – Each type has own sets of processes, applicable
laws and regulations, review times and evidence burden

6. Send your Premarket submission to the FDA and interact with FDA and FDA Staff
during review process.
7. Comply with applicable Regulatory Controls including Establishment Registration
and Device Listing.
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 Premarket Submission Types
Investigational Device Exemption (IDE)

Premarket Notifictaion (510 (k))

Premarket Approval Application

De Novo Application

Humanitarian Device Exemption (HDE)

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 Investigational Device Exemption (IDE)

Clinical research on investigational devices

Collect safety and effectiveness data for future
marketing application
Requires approval by Institutional
Review Board
Protect human patients

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 Premarket Notification (510 (k))

Market application for low and moderate risk devices

(Some class I and most class II devices)
Establish “Substantial Equivalence” between new
device and a legally marketed device
Compare
• intended use
• device features
• performance testing

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 Premarket Approval Application

Market application for highest risk devices

Reasonable assurance:
 safety and effectiveness
Evidence stands on own
 not equivalence

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 De Novo Application

 Device has no existing classification regulation

 Marketing process for novel devices of low to moderate risk
 Creates new classification regulation
 Alternative to PMA
 General controls alone, or general and special controls,
provide reasonable assurance of safety and effectiveness for
the intended use, but for which there is no legally marketed
predicate device.
 Reduced regulatory burden/controls based on risk-benefit
profile of device
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 Humanitarian Device Exemption (HDE)

 Premarket submission for Humanitarian Use Devices

 Possible route to market medical devices that may
help people with a rare diseases or conditions
 8000 individuals per year in United States
 Exempt from effectiveness
 Reasonable assurance of safety and probable benefit

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Establishment Registration Device Listing
 Informs FDA where an establishment is located  Establishments that are
 Establishments that are involved in the production required to register with the
and distribution of medical devices intended for FDA are also required to list the
commercial distribution in the United States (U.S.), devices that are made there and
including those that are imported for export only, the activities that are
are required to register annually with the FDA. performed on those devices.

 Registration and listing provide the FDA with the location of medical device establishments and
the devices manufactured at those establishments.
 Registration and listing is required at time of initial distribution and, subsequently, on an annual
basis.
 You may pay the annual registration fee electronically at the Device Facility User Fee (DFUF)
website.
 Registration and listing information is submitted by using FDA’s Unified Registration and Listing
System (FURLS)/ Device Registration and Listing Module (DRLM).

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CDRH Portal for Online Submissions

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 Global Regulatory Plan
 GRP should be designed from the project’s outset, with all target markets in mind to avoid
duplication of studies and data gaps.
 Key GRP elements include:
• Executive summary
• Target countries list
• Target regions’ regulatory landscape assessment and country-specific regulatory references
• Regulatory pathway selected and rationale
• Description of specific project deliverables
• Critical risks and mitigation plan
• Submission requirements for each market, including timing and fees
• Definition of additional requirements such as quality compliance and facility inspection
requirements
• Health Authority interaction strategy

 GRP aids in blending a multitude of country-specific requirements into an integrated global

regulatory strategy.

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 Key Regulatory Questions During Development
Key Area Considerations for Product Development
Intended Use What are the proposed indications for use?
What is the target patient populations(s)?
Is it intended for prescription or over-the-counter use?
Could the product qualify for expedited review or humanitarian use designation?

Description What features are proposed for marketing?

Which characteristics could be significant from a regulatory perspective?
Are there any device accessories and will they require approval/clearance?
Claims Are there unique claims for which regulatory approval is required (or desirable)?

Lifecycle issues What short- and long-term changes are anticipated

Will older generations of the device be removed from the marketplace?
Device How does the device meet the definition of a medical device?
Classification Does it have drug and/or biologic components?
Is the device invasive?
Is the device software?
Will the device be supplied sterile?
Is the product prescription use only?
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 Key Regulatory Questions During Development
Key Area Considerations for Product Development
Standards What are the international standards applicable to the product?
Are there other ways to demonstrate compliance with the applicable legal obligations?
Clinical Is a clinical investigation required?
investigations If so, does the device meet the criteria as a significant risk device?
What are the requirements for informed consent?
What are the roles of the IRB or IEC?
What is required for regulatory approval and notification for trial initiation, trial conduct and trial
suspension?
Has clinical supply manufacturing been considered?
What are the requirements for unanticipated adverse device effects and reporting of all adverse device
effects?

Packaging and Device labelling on the outer package and instructions for use must meet certain requirements. Also,
labelling all medical devices must contain a statement about any time limitations on their safe use.

Premarket Technical documentation including all Stability testing reports, biocompatibility reports, sterilization
documentation reports, Design validation reports, preclinical testing reports etc.
Post market Have the postmarket deliverables been considered?
documentation
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 Submission Template for 510 (k) Submissions (eSTAR)
Key Area Description
Submission Identification of key information that may be useful to FDA in the initial processing and review
Type of the 510(k) submission
Cover Letter / Attach a cover letter and any documents that refer to other submissions
Letters of
Reference
Applicant Information on the applicant and correspondent, if applicable
Information
Pre- Information on prior submissions for the same device included in the current submission, such
Submission as submission numbers for a prior not substantially equivalent (NSE) determination, prior
Corresponden deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application,
ce & Previous premarket approval (PMA) application, humanitarian device exemption (HDE) application, or
Regulator De Novo classification request.
Interaction

Consensus Identification of voluntary consensus standard(s) used, if applicable

Standards
Device A description of the technological characteristics of the device including materials, design,
Description energy source, and other device features N.S.D.C
 Submission Template for 510 (k) Submissions (eSTAR)
Key Area Description
Proposed Identification of the proposed indications for use of the device and its intended use
Indications for Use
Classification Identification of the classification regulation number that seems most appropriate for the
subject device, as applicable.
Predicates and Identification of a predicate device (e.g., 510(k) number, De Novo number, reclassified
Substantial PMA number, classification regulation reference, if exempt and limitations to exemption
Equivalence are exceeded, or statement that the predicate is a preamendments device).

Detailed comparison of the predicate and subject device and a discussion why any
differences between the subject and predicate do not impact safety and effectiveness

Design/Special Applicable to Special 510(k) submissions only.

Controls, Risks to Identification of the device changes and the risk analysis method(s) used to assess the
Health, and impact of the change(s) on the device and the results of the analysis.
Mitigation
Measures

Labeling Submission of proposed device labels, instructions for use, and any patient labeling
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 Submission Template for 510 (k) Submissions (eSTAR)
Key Area Description
Reprocessing Information for assessing the reprocessing validation and labeling, if applicable
Sterility Information on sterility and validation methods, if applicable.
Shelf Life Summary of methods used to establish that device performance is maintained for the
entirety of the proposed shelf-life.
Biocompatibility Information on the biocompatibility assessment of patient contacting materials, if
applicable.
Software/Firmware Submission of applicable software documentation, if applicable.
Cybersecurity/ Submission of applicable information regarding the assessment of cybersecurity, if
Interoperability applicable.
Electromagnetic Submission of the EMC, Electrical, Mechanical, Wireless and Thermal Safety testing for
Compatibility (EMC), your device or summarize why testing is noSubmission of the EMC, Electrical,
Electrical, Mechanical, Wireless and Thermal Safety testing for your device or summarize why
Mechanical, testing is not needed.t needed.
Wireless and
Thermal Safety

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 Required Elements for PMA Application
Key Area Description
Administrative Applicant details
information
Summary Section - Device Description, Intended use, indications for use, marketing history,
- summary of the results of technical data (nonclinical and clinical studies),
- A concluding discussion must present benefit and risk considerations related to the
device, including a discussion of any adverse effects of the device on health, and any
proposed additional studies or surveillance that the applicant intends to conduct
following approval of the PMA.

Standards information Reference to any performance standard or voluntary standard.

Technical sections • Results of nonclinical laboratory studies (microbiological, toxicological,
immunological, biocompatibility, stress, wear, shelf life, and other laboratory or
animal tests, as appropriate)
• Results of clinical investigations involving human subjects
• A bibliography of all published reports, if any

• One or more samples of the device and its components

• Copies of all proposed labeling for the device
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 De Novo Application Process

Pathway 1 Pathway 2

• attempt 510(k) route

with proposed predicate
device Useful if you believe
proposed device is
viable de novo
candidate (esp. with
• submission found not feedback from Pre-
substantially equivalent Sub program)
(NSE) by FDA, but
candidate was asked to
go for de novo

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 Required Contents for De Novo Application
Key Area Description
Administrative Applicant details
information
Summary Section - Device's intended use, prescription use or over-the-counter use designated, etc.
- Device Description, which includes but is not limited to technology, proposed
conditions of use, accessories, and components.
Classification - The classification being recommended under section 513 of the Federal Food, Drug,
Information and Cosmetic Act (FD&C Act);
- Clinical data (if applicable) that are relevant to support reasonable assurance of the
safety and effectiveness of the device.
- Non-clinical data including bench performance testing.
- Reprocessing and sterilization, shelf life, biocompatibility, software, electrical safety
and electromagnetic compatibility, animal study, literature (if applicable); and
- Ddescription of the probable benefits of the device when compared to the probable or
anticipated risks when the device is used as intended. escription of the probable benefits of
the device when compared to the probable or anticipated risks when the device is
used as intended.

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 Discussion on Clinical Trials Applications

 A clinical study involves research using human volunteers (also called participants) that is
intended to add to medical knowledge.
 There are two main types of clinical studies:
Clinical trials (also called interventional studies) and observational studies.
 In a clinical trial, participants receive specific interventions according to the research plan or
protocol created by the investigators. These interventions may be medical products, such as
drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials
may compare a new medical approach to a standard one that is already available, to a
placebo that contains no active ingredients, or to no intervention.
 Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical
studies also have a research team that may include doctors, nurses, social workers, and
other health care professionals.

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 Clinical Trials Phases
• Study Participants: 20 to 100 healthy volunteers or people with the

Phase 1 disease/condition.
• Length of Study: Several months
• Purpose: Safety and dosage

Phase 2
• Study Participants: Up to several hundred people with the disease/condition.
• Length of Study: Several months to 2 years
• Purpose: Efficacy and side effects

Phase 3
• Study Participants: 300 to 3,000 volunteers who have the disease or condition
• Length of Study: 1 to 4 years
• Purpose: Efficacy and monitoring of adverse reactions

Phase 4
• Study Participants: Several thousand volunteers who have the
disease/condition
• Purpose: Safety and efficacy

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 Discussion on Clinical Trials Applications
 Preparing the Application
Understand Regulatory Requirements and Gather Documentation
 Writing the Application
Clinical Trial Protocol; Investigator's Brochure; Informed Consent Form
 Compilation and Formatting
Compile the Application and Formatting
 Regulatory Submission
Submission Form; Cover Letter; Submission Platform
 Review and Follow-Up
Review Submission; Confirmation of Receipt
 Regulatory Review
Review process and Clarifications
 Approval and Initiation
After the approval of protocol, we can initiate the clinical trial as per approved protocol and regulatory guidelines

N.S.D.C
 Questainnaire

1. What is the purpose of an Investigational Device Exemption (IDE)

submission?

a. Post-approval compliance check

b. Clinical trial initiation in the EU
c. Regulatory approval for medical devices
d. Manufacturing documentation validation

N.S.D.C
 Questainnaire

2. Which pathway is suitable for novel medical devices without a

predicate?

a. 510(k)
b. HDE
c. De Novo
d. IDE

N.S.D.C
 Questainnaire

3. What does a Premarket Notification (510(k)) application aim to

demonstrate?

a. Device safety and effectiveness

b. Substantial equivalence to a legally marketed device
c. Novelty and uniqueness
d. Clinical trial protocol

N.S.D.C
 Questainnaire

4. When a Humanitarian Device Exemption (HDE) application is

typically submitted?

a. For common medical devices

b. For devices with proven efficacy
c. For rare diseases or conditions
d. After post-approval compliance check

N.S.D.C
 Questainnaire

5. What is the purpose of a Clinical Trial Application (CTA)

submission?

a. Manufacturing license approval

b. Regulatory compliance assessment
c. Ethical considerations for clinical trials
d. Unique Identification number assignment

N.S.D.C
Thank you

N.S.D.C