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REGULATION FOR
COMBINATION PRODUCTS
AND MEDICAL DEVICES
INDUSTRYAND FDA LIAISON
FACULTY-IN-CHARGE:
Smt.ROMA MATHEW
ASSISTANT PROFESSOR
DEPARTMENT OF PHARMACEUTICS
PRESENTED BY:
LANIYA NASRIN K
FIRST SEMESTER M PHARM
DEPARTMENT OF PHARMACEUTICS
SUBJECT:REGULATORY AFFAIRS
2
REGULATION FOR COMBINATION PRODUCTS
REGULATION FOR MEDICAL DEVICES
INDUSTRY AND FDA LIAISON
PREVIOUS YEAR QUESTIONS
REFERENCES
CONTENTS
REGULATION FOR
COMBINATION
PRODUCTS
3
01
COMBINATION PRODUCTS
As per 21 CFR part 3.2(e)
“The product composed of two or more different types of medical products(a combination
of a drug, device and /or biological product with one another)”
It can be
• A biological product and a device
• A drug and a biological product
• A drug and a device
• A drug, device and a biological product
DRUG
DEVICES
BIOLOGIC
4
COMBINATION PRODUCT THAT
CLASSIFIED AS DRUGS
• PRE-FILLED SYRINGES
• TRANSDERMAL PATCHES
• RBC PROCESSING SOLUTION
• CONTRAST MEDIA
COMBINATION PRODUCTS CLASSIFIED
AS DEVICES
• DRUG IMPREGNATED DEVICES
• INJECTABLE COLLAGEN
• WOUND DRESSING
• BLOOD BAGS CONTAINING ANTI-
COAGULANT
• DRUG COATED DEVICES SUCH AS
CATHETERS ,SHUNTS SENSORS OR
PACEMAKER LEADS
5
TYPES OF COMBINATION PRODUCT
Single entity combination product
Co-packed combination product
Cross labeled combination product
6
7
1.SINGLE ENTITY COMBINATION PRODUCT
A product comprised of two or more regulated
components that are physically, chemically, or
otherwise combined or mixed and produced.
Examples:
1. Pre-filled drug delivery devices-pre-filled
syringes, injector pen, insulin pump or
metered dose inhaler
2. Pre-filled biologic delivery devices-vaccine
in prefilled syringes or nasal spray
3. Transdermal patches
4. Anti-microbial wound dressing
8
2.CO-PACKED COMBINATION PRODUCT
Two or more separate products packaged
together in a single package or as a unit and
comprised of drug and device products,
device and biological products, or biological
and drug products
Examples:
1.Drug or vaccine vial packed with a syringe
2.Liquid medication with dose-dispenser
3.Surgical tray containing surgical
instruments and anesthetic drugs
9
3.CROSS LABELLED COMBINATION PRODUCT
A drug, device, or biological product packaged separately that according to
its investigational plan or proposed labeling is intended for use only with an
approved, individually specified drug, device, or biological product
Examples:
1.Photosensitizing drug and activating laser
2. Light-activated biologic products
10
REGULATION FOR COMBINATION PRODUCT
• The marketing authorization pathways, regulatory standards and procedure for
combination products are essentially for drugs, devices and biological products.
• The PMOA standards determine which center will have the lead for regulation
of a combination product.
• PMOA-PRIMARY MODE OF ACTION:
The single mode of action of a combination product that
provides the most important therapeutic action of combination product.
• The most important therapeutic action is the mode of action expected to
make the greatest contribution to the overall intended therapeutic
effects of combination product.
• Combination product typically have more than one identifiable mode of
action
11
TYPES OF MODE OF ACTION
BIOLOGICAL PRODUCT MOA DEVICE MOA DRUG MOA
If it acts by means of a virus,
therapeutic serum, toxin,
anti-toxin, vaccine, blood,
blood component, allergic
products or analogue
product applicable to the
prevention, treatment or
cure of a disease or
condition of humans
If it meets the
definition of drug and
it does not have a
biological product or
device mode of
action.
If it meets the definition of
device, it does not have a
biological product mode of
action, and it does not achieve
its primary intended purposes
through chemical action within
or on the body and is not
dependent on being
metabolized for the achievement
of its primary intended purposes
12
REVIEW OF COMBINATION PRODUCTS
Determination of the "primary mode of action" (PMOA) of the combination product.
(RFD-Request For Designation submitted allow sponsor to obtain the center for
regulation)
Combination products are assigned to a FDA center that will have primary jurisdiction for
its premarket review and regulation
In some cases, the most important therapeutic action cannot be determined.
FDA's regulations at 21 CFR Part 4 include an algorithm for determining center assignment
13
IDENTIFY THE COMBINATION PRODUCT MODE OF ACTION-1.DRUG & DEVICE 2.DRUG & BIOLOGICAL
PRODUCT 3.DEVICE & BIOLOGICAL PRODUCT 4.DRUG, DEVICE & BIOLOGICAL PRODUCT
WHICH MOA IS PMOA OF COMBINATION PRODUCT
STOP
DEVICE PMOA
ASSIGN
RESPONSIBILITY(CDRH)
STOP
DRUG PMOA
ASSIGN RESPONSIBILITY
TO AGENCY(CDER)
STOP
BIOLOGICAL PRODUCT PMOA
ASSIGN RESPONSIBILITY TO AGENCY
(CBER)
IS THERE AN AGENCY COMPONENT THAT REGULATES
OTHER CP THAT HAVE SIMILAR QUESTIONS OF
SAFETY AND EFFECTIVENESS PRODUCT AS A WHOLE?
STOP
ASSIGN RESPONSIBILITY TO
THAT AGENCY
WHICH AGENCY HAS THE MOST
EXPERTISE RELATED TO THE SAFETY
AND EFFECTIVENESS QUESTIONS
PRESENTE BY THE CP
STOP
ASSIGN TO THE AGENCY HAS
THE MOST EXPERTISE
RELATED TO THE SAFETY
AND EFFECTIVENESS
QUESTIONS PRESENTE BY
THE CP
DEVICE DRUG BIOLOGICAL PRODUCT
UNABLE TO
DETERMINE
WITH
REASONABLE
CERTAINITY
YES
NO
PMOA
/
ASSIGNMENT
ALGORITHM
14
1.PREMARKET REGULATION-MARKETING AUTHORISATION
To consider what investigational and marketing authorization submission to
make for combination product depends on:
I. Which constituent part (drug, device, biological product) provides
PMOA
II. Which submission type are available for combination product
EXAMPLES:
1. If a drug-device combination product has a device PMOA: it includes a
drug that is new molecular entity, a PMA could be submitted
2. If a drug-device combination product has a drug PMOA: it includes
the same drug but different device than a previously approved
combination product for the same indication, an NDA could be
submitted
15
• An NDA for the drug constituent part submitted to CDER(Center For Drug
Evaluation And Research) and a PMA for a device constituent part to
CDRH(Center For Device And Radiological Health)
• MARKETING AUTHORIZATION STANDARDS FOR COMBINATION
PRODUCTS
o The agency which stated the constituent part of combination product
retains their legal status as a drug, device, or biologic.
o Sort of data may be needed to support marketing authorization for a
combination product
o Mainly regarding safety and effectiveness issues of it
o These issues may relate to the product as whole, individual constituent
parts and the interaction of constituent parts
o The more novel the combination product, more issues may need to
be addressed in supporting data-extensive safety and effectiveness
data
16
2.POST MARKET REGULATION OF COMBINATION PRODUCTS
• The combination product are subjected to regulatory requirements
applicable to each of their constituent parts
• A current good manufacturing practice(c GMP), a proposed rule on
post marketing safety reporting(PSR)for combination product and a
final rule on unique identification for devices.
• Centre and office of regulatory affairs may coordinate on
manufacturing facility inspection activities or on evaluation and
response to post market safety reports
17
OFFICE OF COMBINATION PRODUCTS (OCP)
• The Office of Combination Products was established on December 24,
2002 as required by Sec. 204 of the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA).
• Its duties are detailed in section 503(g) of the Federal Food, Drug, and
Cosmetic Act .
• OCP given broad oversight responsibilities covering the regulatory life
cycle of combination products
18
ROLES
OF THE
OCP
To classify medical products as drugs, devices, biological
products or combination products and assign them to an FDA
center for premarket review and regulation, where their
classification or assignment is unclear or in dispute.
To ensure timely and effective premarket review of combination
products by overseeing the timeliness, alignment of
coordination of reviews involving more than one agency center,
including through monitoring and management of the
InterCenter consult process.
To ensure consistent and appropriate post market regulation of
combination products.
19
ROLES
OF THE
OCP
To resolve disputes regarding the timeliness of
premarket review of combination products
To serve as a focal point for combination product
issues and for medical product classification and
assignment issues for agency staff and industry.
To develop guidance and regulations to clarify
the regulation of combination products.
20
STAFF
MEMBERS
OF OCP
Director
Deputy director
Associate director
Lead product jurisdiction officer
Senior scientist reviewer
Senior program manager
Associate clinical director
Senior medical officer
Management analyst
Project management officer
02
REGULATION FOR
MEDICAL DEVICES
21
22
MEDICAL DEVICES
• A medical device is an apparatus, appliance, software material, or other
article whether used alone or in combination, including the software
intended by its manufacturer to be used specifically for diagnostic or
therapeutic purposes and necessary for its proper application.
CDSCO
• An instrument, apparatus, implement, machine, implant, reagent, or
other similar or related article, including a component part or accessory
which is recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement
• Intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals
US
FDA
23
•Any instrument apparatus, appliance, material or other
article(whether used alone or in combination, and
including the software necessary for its proper
application)intended to be used for human beings for:
• Diagnosis, prevention, monitoring, treatment or
alleviation of disease
• Diagnosis, monitoring, treatment, alleviation or
compensation for an injury or handicap
• Investigation, replacement or modification of the
anatomy or of a physiological process
• Control of conception
According
to
Therapeutic
Goods Act
1989
24
CLASSIFICATION OF MEDICAL DEVICES
RISK BASED CLASSIFICATION
CDSCO
CLASS A
CLASS B
CLASS C
CLASS D
US-FDA
CLASS I
CLASS II
CLASS III
EU
CLASS I
CLASS II a
CLASS II b
CLASS III
25
RISK BASED CLASSSIFICATION ACCORDANCE TO CDSCO
CLASS
RISK
LEVEL
EXAMPLES PICTURES
A LOW
BANDAGES, TONGUE
DEPRESSOR
B LOW-
MODERATE
HYPODERMIC
NEEDLES, SUCTION
EQUIPMENT
C MODERATE
-HIGH
LUNG VENTILATOR,
BONE FIXATION
PLATE
D HIGH
PACEMAKERS,
IMPLANTABLE
DEFIBRILLATOR
26
RISK BASED CLASSSIFICATION ACCORDANCE TO US FDA
CLASS
RISK
LEVEL
EXAMPLES PICTURES
I LOW
BANDAGES, TONGUE
DEPRESSOR
II MODERATE NEBULIZERS
III HIGH
PACEMAKERS, INTRA-
OCULAR LENSES
27
RISK BASED CLASSSIFICATION ACCORDANCE TO EU
CLASS RISK LEVEL EXAMPLES PICTURES
I LOW
SURGICAL GUAZE,
WHEEL CHAIRS
II a MODERATE
HEARING AIDS,
ULTRASOUND
EQUIPMENT
II b POTENTIAL
HIGH RISK
INFUSION PUMPS,
SURGICAL LASERS
III HIGH RISK
STUNT GRAFTS,
PROSTHETIC JOINTS
28
ARTICLES DECLARED NOT TO BE MEDICAL DEVICES
•Chemical oxygen
generators
In-vivo imaging
agents
Product intended to
deliver a medicine, where
the medicine and device
are a single integral
product (which is not
reusable)
Products
incorporating tissues,
cells, substances of
human origin
Products
incorporating viable
tissues, cells,
substances of animal
origin
Hospital and household
grade disinfectants
29
• Mobile app used to measure blood glucose levels for monitoring
diabetes.
• Software which analyses and interprets ECG signals.
• Software running an infusion pump to control dose deliver
SOFTWARE AS A MEDICAL DEVICE
30
WHO REGULATES MEDICAL DEVICES?
• THERAPEUTIC GOODS ADMINISTRATION (TGA)
AUSTRALIA
• FOOD AND DRUG ADMINISTRATION(CDRH)
USA
• HEALTH CANADA
CANADA
• THE STATE FOOD AND DRUG ADMINISTRATION(SFDA)
CHINA
• MINISTRY OF HEALTH LABOUR AND WELFARE(MHLW)
JAPAN
• ANVISA
BRAZIL
• CDSCO
INDIA
31
REGULATORY REQUIREMENTS OF MEDICAL DEVICES IN USA
• FDA's Center for Devices and Radiological Health (CDRH) is responsible
for regulating firms who manufacture, repackage, relabel, and/or import
medical devices sold in the United States.
• Each of these generic types of devices is assigned to one of 3 regulatory
classes based on the level of control necessary to assure the safety and
effectiveness of the device.
1. Class I devices are exempt from Premarket Notification (lowest risk)
2. Class II devices require Premarket Notification (moderate risk)
3. Class III devices require Premarket Approval. (high risk)
32
CLASS RISK LEVEL REGULATORY REQUIREMENT
CLASS I LOW General controls
CLASS II MODERATE
General controls
Special controls
• Performance standards
• Post- market surveillance
• Patient registries
• Special labelling
• Pre- market data requirements
• Guidelines
CLASS
III
HIGH
General controls
Premarket approval (PMA)
REGULATORY REQUIREMENTS
33
1. ESTABLISHMENT REGISTRATION:
• Manufacturer/ importers must register their establishment with FDA.
• Information is verified annually (1st Oct- 31st Dec)
2. MEDICAL DEVICE LISTING:
• Manufacturers must list their devices with the FDA, with information about manufacture,
distributor, specification, accessories/ component, remanufacturer, US manufacturer of
“EXPORT ONLY” devices, repackagers and relabelers, specification developers.
CLASS I CLASS II CLASS III
NO FDA APPROVAL NEEDED
Must register device &
company on FDA websites
FDA CLEARANCE REQUIRED
typically via 510(k)
premarket notification
submission
FDA APPROVAL REQUIRED
Typically via
premarket(PMA) approval
process
34
3. PREMARKET NOTIFICATION( 510 K)
• Letter of substantial equivalence from FDA, required before commercial distribution - safe
and effective or substantially equivalent to a legally marketed device
4. PREMARKET APPROVAL (PMA)
• Class III Devices are high risk devices, so they include the submission of clinical data to
support claims made for the device
• PMA is the process of scientific and regulatory review to ensure the safety &
effectiveness of class III devices
5. INVESTIGATIONAL DEVICE EXEMPTION (IDE)
• Allows the Investigational device to be used in a clinical study in order to collect safety
and effectiveness data
• Clinical studies with devices of significant risk must be approved by FDA and by an
Institutional Review Board ( IRB) before the study can begin
35
6.QUALITY SYSTEM REGULATION
• Includes methods, facilities and controls used for designing, purchasing,
manufacturing, packaging, labeling, storing, installing and servicing of medical
devices to assure compliance.
7.LABELING
• Includes labels on the device as well as descriptive and informational
literature that accompanies the device
8.MEDICAL DEVICE REPORTING
• To detect and correct problems in a timely manner and to identify and
monitor significant adverse events involving medical devices.
36
• In India medical devices are governed by CDSCO which is regulated by Directorate General
of Health Services, Ministry of Health & Family Welfare, Govt. of India.
• CDSCO is the only government body which regulate the medical devices
• Medical devices are regulated by the Drug Controller General of India (DCGI)within the
CDSCO
• MEDICAL DEVICES CLASSIFIED AS:
1. CLASS A
2. CLASS B
3. CLASS C
4. CLASS D
REGULATORY REQUIREMENTS OF MEDICAL DEVICES IN INDIA
37
REGULATORY BODY FOR MEDICAL DEVICES
DRUG CONTROLLER GENERAL OF INDIA(DCGI)
DEPUTY DRUG CONTROLLER
ASSISTANT DRUG CONTROLLER
MEDICAL DEVICE
CELL
DRUG
INSPECTOR
TECHNICAL DATA
ASSOCIATE
DIAGNOSTIC
DRUG
INSPECTOR
TECHNICAL DATA
ASSOCIATE
38
FUNCTION
OF
MEDICAL
DEVICE
CELL
Import, registration and licensing of medical devices
Approval of new medical devices
Manufacturing license to indigenous manufacturer under CLAA
scheme
Grant of test license
NOCs for import
Neutral code for export
Clinical trials
39
APPROVAL PROCESS
DETERMINE IF THE PRODUCT REQUIRES REGISTRATION
APPOINT AUTHORISED INDIAN AGENT
SUBMIT THE REGULATORY DOSSIER UNDER FORM 40
OBTAIN REGISTRATION CERTIFICATE IN FORM 41
OBTAIN IMPORT LICENSE IN FORM 10(VALID UPTO 3 YEARS)
MARKETING IN INDIA
40
•STATE LICENSING
AUTHORITY
FOR CLASS
A & B
MEDICAL
DEVICE
•CENTRAL LICENSING
AUTHORITY
FOR CLASS
C & D
MEDICAL
DEVICES
REGISTRATION
OF
MEDICAL
DEVICES
41
MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION
CLASS A CLASS B CLASS C CLASS D
APPLICATION-ONLINE PORTAL OF THE MINISTRY OF HEALTH AND FAMILY WELFARE(SUGAM)
SCRUTINY BY STATE LICENSING
AUTHORITY(SLA)
SCRUTINY BY CENTRAL
LICENSING AUTHORITY(CLA)
LICENSE
TECHNICAL REVIEW(4TH SCHEDULE)
AND ONSITE AUDIT(5TH SCHEDULE)
BY NOTIFIED BODY
TECHNICAL REVIEW(4TH SCHEDULE) AND ONSITE
AUDIT(5TH SCHEDULE) BY CLA MAY AVAIL
SERVICE OF A NOTIFIED BODY OR AN EXPERT
LICENSE
42
INDIAN MEDICAL DEVICE REGULATORY ACT(IMRDA)
Indian Medical Devices Regulatory Act come in force December 31, 2009
Central Government
Eminent Jurist
Two eminent medical practitioners
Two eminent medical technologists
Secretary General Quality council
COMPOSITION
OF THE
COMMITTEE
43
OBJECTIVES OF IMRDA
Provide notification of essential
principles
Provide for risk based classification of
device
Notify standards and guidelines
Provide mechanism of conformity
Provide a post market surveillance
system
Provide for enforcement
IMRDA ESSENTIAL PRINCIPLES
•Should not compromise health and
safety.
Design and manufacture of devices
must conform with safety principles.
Long term safety should be ensured.
Benefits of the devices must outweigh
any side effects.
Medical devices should be useful for the
intended purpose.
44
IMRDA-THE REGULATION
Will issue:
1.Design and manufacturing requirements.
2.Performance evaluation.
3.Demonstration of device standards, testing and
compliance.
4.Regulation of post marketing follow up.
5.Regulation of recalls.
6.Legislate and punishment for non compliance.
7.Principle of safety.
45
03
INDUSTRY
AND FDA
LIAISON
46
• Liaison means Communication or Co-operation.
• Every Pharmaceutical industry must follow some of the regulations held
by its higher authorities.
• FDA also lays some of the regulations in order to maintain the quality
and safety of drugs and pharmaceutical products.
• Effective communication should be maintained between
Pharmaceutical Industries and FDA.
INDUSTRY AND FDA LIAISONS
47
FDA(FOOD AND DRUG ADMNISTRATION)
• The Food and drug Administration (FDA) is one of the oldest consumer protection
agency.
• FDA is a public health agency, charged with protecting American consumers by
enforcing the Federal Food, Drug and Cosmetic Act and several related public
health laws
• FDA ensures the safety, efficacy and security of human and veterinary drugs,
biological products and medical devices
• Also ensure the safety of food supply, cosmetics and products that emits radiation
48
RESPONSIBILITIS OF FDA
• Food safety and Dietary supplements
• Animal foods and feeds
• Tobacco products
• Prescription and other OTC drugs
• Vaccines and Biopharmaceuticals
• Blood transfusions
• Medical devices
• Cosmetics
• Veterinary products
FDA is responsible
for protecting and
promoting public
health through
control and
supervision of the
following categories
49
MISSION OF
FDA
SCIENTIFIC
EXPERTISE
PRODUCT
SAFETY
INSPECTIONS &
LEGAL
SANCTIONS
50
1.INSPECTIONS & LEGAL SANCTIONS
•They ensures that the products are made correctly
and labeled truthfully.
•They collect about 80,000 domestic and imported
product samples for examination by FDA scientists for
for label checks.
•If a company is found violating any of the laws, the
FDA can encourage the firm to correct the problem
voluntarily or to recall a faulty product from the
market.
•When a company cannot or will not voluntarily
correct the problem with one of its products, the FDA
has legal sanctions it can bring to bear.
51
2.SCIENTIFIC EXPERTISE
•The scientific evidence needed to back up the FDA’s
legal cases is prepared by the agency’s 2,100 scientists,
including 900 chemists and 300 microbiologists.
•Some of these scientists analyze samples and others
review test results submitted by companies seeking
agency approval for drugs, vaccines, food additives,
coloring agents, and medical devices.
•The agency must determine that the new drug
produces the benefits it is supposed to without
causing side effects that would outweigh those
benefits.
52
3.PRODUCT SAFETY
•The agency’s scientists test samples to see if any
substances, such as pesticide residues, are present in
unacceptable amounts.
• If contaminants are identified, the FDA takes
corrective action.
•The safety of blood supply is another FDA
responsibility. The agency’s investigators routinely
examine blood bank operations, from record-keeping
to testing for contaminants.
•Cosmetic safety also comes under the FDA’s
jurisdiction. The agency can have unsafe cosmetics
removed from the market.
53
FDA ORGANISATIONS
54
CENTER AREA OF RESPONSIBILITY
CENTER FOR DRUG EVALUATION AND RESEARCH Safety and effectiveness of Prescription and OTC drugs
CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH
Safety and effectiveness of vaccines, nation's blood supply,
Biologics
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Safety and effectiveness of Medical devices, diagnostic
tests, Radiation emitting devices
CENTER FOR FOOD SAFETY AND APPLIED
NUTRITION
Safety of domestic and imported food supply, cosmetics
and dietary supplements
CENTER FOR VETERINARY MEDICINE Safety and effectiveness of veterinary drugs
CENTER FOR TOBACCO PRODUCTS Implementation of the Family Smoking Prevention and
Tobacco Control Act
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH Research to support regulatory decisions and reduce risks
associated with FDA regulated products
OFFICE OF REGULATORY AFFAIRS Enforcement of Laws and regulations
DIVISIONS OF FDA
CENTER FOR DRUG EVALUATION & RESEARCH(CDER)
CENTER FOR BIOLOGICS EVALUATION & RESEARCH(CBER)
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH(CDRH)
CENTER FOR FOOD SAFETY & APPLIED NUTRITION(CFSAN)
CENTER FOR VETERINERY MEDICINE(CVM)
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH(NCTR)
56
• CDER's mission is to ensure that safe and effective prescription, non-
prescription and generic drugs are available to the people as quickly as
possible.
• CDER fulfills its mission by overseeing the clinical research, development,
manufacture, and marketing of drugs.
• Responsible for reviewing all INDS, NDAs, and chemistry and efficacy
supplemental applications.
• CDER ensures that drug labeling, drug information for patients, and drug
promotion are truthful, helpful, and not misleading.
CENTER FOR DRUG EVALUATION AND RESEARCH(CDER)
57
FUNDAMENTAL GOALS
AND OBJECTIVES
Promote public health by ensuring
the availability of safe and effective
drugs
Protect public health by promoting
the safe use of marketed drugs
Protect public health by ensuring the
quality and integrity of marketed
drug products.
CDER ORGANISATION
NEW DRUG DEVELOPMENT AND
REVIEW
POST-MARKET DRUG
SURVEILLANCE
GENERIC DRUG REVIEW PROCESS
OTC DRUG REVIEW
58
• One of CDER's primary goals is to work collaboratively and cooperatively with
industry To improve the drug development and review process.
• It also strives to provide consumers and health care providers with drug
information that is vital for improving the public health.
CONTACT WITH FDA
VARIOUS MEANS OF COMMUNICATING WITH CDER
1.CONSUMER/INDUSTRY
INQUIRIES
2.INDUSTRY/FDA
INQUIRIES
3.FDA/INDUSTRY
MEETING
59
1.CONSUMER/INDUSTRY INQUIRIES
• To enhance the communications aspect of this process, the Center created the
Division of Communications Management (DCM).
• This division enhances information exchange, strategic communications
planning, and the development of communications products and initiatives.
• The Division of Communications Management works to ensure that
pharmaceutical industry representatives, health care professionals,
government officials, and consumers have easy and open access to
information and are educated about the drug regulation process and the
benefits and risks of drugs.
60
The newest and easiest method for getting
information is the Center's world wide web
homepage at http://www.fad.gov/cder.
For more specific or complex drug inquiries,
individuals may telephone the Drug Information
Branch or send an electronic mail.
For specific inquiries from industry, CDER's
Compendia Operations
Ways
consumers and
industry
representatives
can
communicate
with the center
61
2.FDA/INDUSTRY MEETINGS
• All meetings with the FDA are held at the pleasure of the agency
and should be requested judiciously.
• Project managers, are responsible for coordinating FDA/industry
meetings.
• If a meeting with the FDA is deemed necessary, the first step is to
telephone the project manager assigned to the firm's IND or NDA.
• The need for a meeting should be explained, a statement about
the general topic of the meeting should be described, and an idea
of when the meeting is needed should be offered.
62
• The project manager will likely return the call and indicate if a meeting
will be granted.
• If the answer is positive, a confirmatory letter from the firm should be
sent to the appropriate division.
• The document should include the fact that the meeting has been
granted and what the date for the meeting will be.
• The names and titles of those representatives of the sponsor who will
be attending the meeting, and the proposed agenda are provided.
63
CATEGORIES OF MEETING INDUSTRY CAN REQUEST TO AGENCY
TYPES A TYPE B TYPE C
TYPE A
• Most important.
• To dispute issues that arise during new drug
development, or to resolve clinical holds that the FDA
has deemed necessary.
• These meetings are usually scheduled 30 days from
FDAs receipt of a written request for a meeting.
64
TYPE B
• Usually occur for a pre-IND, an end of phase 1 (EOP1), an end of
phase 2 (EOP2), or a pre-NDA or BLA Conference
• Usually scheduled 60 days from the time the agency received
the written request.
TYPE C
• Any other meeting not falling into type A or B meetings.
• These are meetings that pertain to the review of human drug
applications.
• These meetings are usually scheduled within 75 days of the
agency’s of the written request.
04
10 MARKS
1. Explain the regulatory requirement of
medical devices for market authorisation
2. Describe the regulation for combination
products and medical devices
5 MARKS
1. Explain FDA liaisons for industries
PREVIOUS
YEARS
QUESTIONS
65
05
1. Regulation of combination product in US, FDA Regulatory
Affairs, David Manthus & Douglas J Pisano,3rd edition,
pageno:361
2. FDA medical device Regulation, FDA Regulatory Affairs,
David Manthus & Douglas J Pisano,3rd edition,
pageno:125
3. Regulation of combination product, www.ecfr.gov.in
4. Combination product, www.fda.gov.in
5. Medical device and diagnostics, www.cdsco.gov.in
6. India medical device regulation, www.tuvsud.com
7. New drug approval process, Richard A Guarino,4th edition
page no:287
REFERENCES
66
THANK
YOU
67
GOVERNMENT MEDICAL COLLEGE, THIRUVANANTHAPURAM

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REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx

  • 1. REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES INDUSTRYAND FDA LIAISON FACULTY-IN-CHARGE: Smt.ROMA MATHEW ASSISTANT PROFESSOR DEPARTMENT OF PHARMACEUTICS PRESENTED BY: LANIYA NASRIN K FIRST SEMESTER M PHARM DEPARTMENT OF PHARMACEUTICS SUBJECT:REGULATORY AFFAIRS
  • 2. 2 REGULATION FOR COMBINATION PRODUCTS REGULATION FOR MEDICAL DEVICES INDUSTRY AND FDA LIAISON PREVIOUS YEAR QUESTIONS REFERENCES CONTENTS
  • 4. COMBINATION PRODUCTS As per 21 CFR part 3.2(e) “The product composed of two or more different types of medical products(a combination of a drug, device and /or biological product with one another)” It can be • A biological product and a device • A drug and a biological product • A drug and a device • A drug, device and a biological product DRUG DEVICES BIOLOGIC 4
  • 5. COMBINATION PRODUCT THAT CLASSIFIED AS DRUGS • PRE-FILLED SYRINGES • TRANSDERMAL PATCHES • RBC PROCESSING SOLUTION • CONTRAST MEDIA COMBINATION PRODUCTS CLASSIFIED AS DEVICES • DRUG IMPREGNATED DEVICES • INJECTABLE COLLAGEN • WOUND DRESSING • BLOOD BAGS CONTAINING ANTI- COAGULANT • DRUG COATED DEVICES SUCH AS CATHETERS ,SHUNTS SENSORS OR PACEMAKER LEADS 5
  • 6. TYPES OF COMBINATION PRODUCT Single entity combination product Co-packed combination product Cross labeled combination product 6
  • 7. 7 1.SINGLE ENTITY COMBINATION PRODUCT A product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced. Examples: 1. Pre-filled drug delivery devices-pre-filled syringes, injector pen, insulin pump or metered dose inhaler 2. Pre-filled biologic delivery devices-vaccine in prefilled syringes or nasal spray 3. Transdermal patches 4. Anti-microbial wound dressing
  • 8. 8 2.CO-PACKED COMBINATION PRODUCT Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products Examples: 1.Drug or vaccine vial packed with a syringe 2.Liquid medication with dose-dispenser 3.Surgical tray containing surgical instruments and anesthetic drugs
  • 9. 9 3.CROSS LABELLED COMBINATION PRODUCT A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved, individually specified drug, device, or biological product Examples: 1.Photosensitizing drug and activating laser 2. Light-activated biologic products
  • 10. 10 REGULATION FOR COMBINATION PRODUCT • The marketing authorization pathways, regulatory standards and procedure for combination products are essentially for drugs, devices and biological products. • The PMOA standards determine which center will have the lead for regulation of a combination product. • PMOA-PRIMARY MODE OF ACTION: The single mode of action of a combination product that provides the most important therapeutic action of combination product. • The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of combination product. • Combination product typically have more than one identifiable mode of action
  • 11. 11 TYPES OF MODE OF ACTION BIOLOGICAL PRODUCT MOA DEVICE MOA DRUG MOA If it acts by means of a virus, therapeutic serum, toxin, anti-toxin, vaccine, blood, blood component, allergic products or analogue product applicable to the prevention, treatment or cure of a disease or condition of humans If it meets the definition of drug and it does not have a biological product or device mode of action. If it meets the definition of device, it does not have a biological product mode of action, and it does not achieve its primary intended purposes through chemical action within or on the body and is not dependent on being metabolized for the achievement of its primary intended purposes
  • 12. 12 REVIEW OF COMBINATION PRODUCTS Determination of the "primary mode of action" (PMOA) of the combination product. (RFD-Request For Designation submitted allow sponsor to obtain the center for regulation) Combination products are assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation In some cases, the most important therapeutic action cannot be determined. FDA's regulations at 21 CFR Part 4 include an algorithm for determining center assignment
  • 13. 13 IDENTIFY THE COMBINATION PRODUCT MODE OF ACTION-1.DRUG & DEVICE 2.DRUG & BIOLOGICAL PRODUCT 3.DEVICE & BIOLOGICAL PRODUCT 4.DRUG, DEVICE & BIOLOGICAL PRODUCT WHICH MOA IS PMOA OF COMBINATION PRODUCT STOP DEVICE PMOA ASSIGN RESPONSIBILITY(CDRH) STOP DRUG PMOA ASSIGN RESPONSIBILITY TO AGENCY(CDER) STOP BIOLOGICAL PRODUCT PMOA ASSIGN RESPONSIBILITY TO AGENCY (CBER) IS THERE AN AGENCY COMPONENT THAT REGULATES OTHER CP THAT HAVE SIMILAR QUESTIONS OF SAFETY AND EFFECTIVENESS PRODUCT AS A WHOLE? STOP ASSIGN RESPONSIBILITY TO THAT AGENCY WHICH AGENCY HAS THE MOST EXPERTISE RELATED TO THE SAFETY AND EFFECTIVENESS QUESTIONS PRESENTE BY THE CP STOP ASSIGN TO THE AGENCY HAS THE MOST EXPERTISE RELATED TO THE SAFETY AND EFFECTIVENESS QUESTIONS PRESENTE BY THE CP DEVICE DRUG BIOLOGICAL PRODUCT UNABLE TO DETERMINE WITH REASONABLE CERTAINITY YES NO PMOA / ASSIGNMENT ALGORITHM
  • 14. 14 1.PREMARKET REGULATION-MARKETING AUTHORISATION To consider what investigational and marketing authorization submission to make for combination product depends on: I. Which constituent part (drug, device, biological product) provides PMOA II. Which submission type are available for combination product EXAMPLES: 1. If a drug-device combination product has a device PMOA: it includes a drug that is new molecular entity, a PMA could be submitted 2. If a drug-device combination product has a drug PMOA: it includes the same drug but different device than a previously approved combination product for the same indication, an NDA could be submitted
  • 15. 15 • An NDA for the drug constituent part submitted to CDER(Center For Drug Evaluation And Research) and a PMA for a device constituent part to CDRH(Center For Device And Radiological Health) • MARKETING AUTHORIZATION STANDARDS FOR COMBINATION PRODUCTS o The agency which stated the constituent part of combination product retains their legal status as a drug, device, or biologic. o Sort of data may be needed to support marketing authorization for a combination product o Mainly regarding safety and effectiveness issues of it o These issues may relate to the product as whole, individual constituent parts and the interaction of constituent parts o The more novel the combination product, more issues may need to be addressed in supporting data-extensive safety and effectiveness data
  • 16. 16 2.POST MARKET REGULATION OF COMBINATION PRODUCTS • The combination product are subjected to regulatory requirements applicable to each of their constituent parts • A current good manufacturing practice(c GMP), a proposed rule on post marketing safety reporting(PSR)for combination product and a final rule on unique identification for devices. • Centre and office of regulatory affairs may coordinate on manufacturing facility inspection activities or on evaluation and response to post market safety reports
  • 17. 17 OFFICE OF COMBINATION PRODUCTS (OCP) • The Office of Combination Products was established on December 24, 2002 as required by Sec. 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). • Its duties are detailed in section 503(g) of the Federal Food, Drug, and Cosmetic Act . • OCP given broad oversight responsibilities covering the regulatory life cycle of combination products
  • 18. 18 ROLES OF THE OCP To classify medical products as drugs, devices, biological products or combination products and assign them to an FDA center for premarket review and regulation, where their classification or assignment is unclear or in dispute. To ensure timely and effective premarket review of combination products by overseeing the timeliness, alignment of coordination of reviews involving more than one agency center, including through monitoring and management of the InterCenter consult process. To ensure consistent and appropriate post market regulation of combination products.
  • 19. 19 ROLES OF THE OCP To resolve disputes regarding the timeliness of premarket review of combination products To serve as a focal point for combination product issues and for medical product classification and assignment issues for agency staff and industry. To develop guidance and regulations to clarify the regulation of combination products.
  • 20. 20 STAFF MEMBERS OF OCP Director Deputy director Associate director Lead product jurisdiction officer Senior scientist reviewer Senior program manager Associate clinical director Senior medical officer Management analyst Project management officer
  • 22. 22 MEDICAL DEVICES • A medical device is an apparatus, appliance, software material, or other article whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application. CDSCO • An instrument, apparatus, implement, machine, implant, reagent, or other similar or related article, including a component part or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals US FDA
  • 23. 23 •Any instrument apparatus, appliance, material or other article(whether used alone or in combination, and including the software necessary for its proper application)intended to be used for human beings for: • Diagnosis, prevention, monitoring, treatment or alleviation of disease • Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap • Investigation, replacement or modification of the anatomy or of a physiological process • Control of conception According to Therapeutic Goods Act 1989
  • 24. 24 CLASSIFICATION OF MEDICAL DEVICES RISK BASED CLASSIFICATION CDSCO CLASS A CLASS B CLASS C CLASS D US-FDA CLASS I CLASS II CLASS III EU CLASS I CLASS II a CLASS II b CLASS III
  • 25. 25 RISK BASED CLASSSIFICATION ACCORDANCE TO CDSCO CLASS RISK LEVEL EXAMPLES PICTURES A LOW BANDAGES, TONGUE DEPRESSOR B LOW- MODERATE HYPODERMIC NEEDLES, SUCTION EQUIPMENT C MODERATE -HIGH LUNG VENTILATOR, BONE FIXATION PLATE D HIGH PACEMAKERS, IMPLANTABLE DEFIBRILLATOR
  • 26. 26 RISK BASED CLASSSIFICATION ACCORDANCE TO US FDA CLASS RISK LEVEL EXAMPLES PICTURES I LOW BANDAGES, TONGUE DEPRESSOR II MODERATE NEBULIZERS III HIGH PACEMAKERS, INTRA- OCULAR LENSES
  • 27. 27 RISK BASED CLASSSIFICATION ACCORDANCE TO EU CLASS RISK LEVEL EXAMPLES PICTURES I LOW SURGICAL GUAZE, WHEEL CHAIRS II a MODERATE HEARING AIDS, ULTRASOUND EQUIPMENT II b POTENTIAL HIGH RISK INFUSION PUMPS, SURGICAL LASERS III HIGH RISK STUNT GRAFTS, PROSTHETIC JOINTS
  • 28. 28 ARTICLES DECLARED NOT TO BE MEDICAL DEVICES •Chemical oxygen generators In-vivo imaging agents Product intended to deliver a medicine, where the medicine and device are a single integral product (which is not reusable) Products incorporating tissues, cells, substances of human origin Products incorporating viable tissues, cells, substances of animal origin Hospital and household grade disinfectants
  • 29. 29 • Mobile app used to measure blood glucose levels for monitoring diabetes. • Software which analyses and interprets ECG signals. • Software running an infusion pump to control dose deliver SOFTWARE AS A MEDICAL DEVICE
  • 30. 30 WHO REGULATES MEDICAL DEVICES? • THERAPEUTIC GOODS ADMINISTRATION (TGA) AUSTRALIA • FOOD AND DRUG ADMINISTRATION(CDRH) USA • HEALTH CANADA CANADA • THE STATE FOOD AND DRUG ADMINISTRATION(SFDA) CHINA • MINISTRY OF HEALTH LABOUR AND WELFARE(MHLW) JAPAN • ANVISA BRAZIL • CDSCO INDIA
  • 31. 31 REGULATORY REQUIREMENTS OF MEDICAL DEVICES IN USA • FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. • Each of these generic types of devices is assigned to one of 3 regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. 1. Class I devices are exempt from Premarket Notification (lowest risk) 2. Class II devices require Premarket Notification (moderate risk) 3. Class III devices require Premarket Approval. (high risk)
  • 32. 32 CLASS RISK LEVEL REGULATORY REQUIREMENT CLASS I LOW General controls CLASS II MODERATE General controls Special controls • Performance standards • Post- market surveillance • Patient registries • Special labelling • Pre- market data requirements • Guidelines CLASS III HIGH General controls Premarket approval (PMA) REGULATORY REQUIREMENTS
  • 33. 33 1. ESTABLISHMENT REGISTRATION: • Manufacturer/ importers must register their establishment with FDA. • Information is verified annually (1st Oct- 31st Dec) 2. MEDICAL DEVICE LISTING: • Manufacturers must list their devices with the FDA, with information about manufacture, distributor, specification, accessories/ component, remanufacturer, US manufacturer of “EXPORT ONLY” devices, repackagers and relabelers, specification developers. CLASS I CLASS II CLASS III NO FDA APPROVAL NEEDED Must register device & company on FDA websites FDA CLEARANCE REQUIRED typically via 510(k) premarket notification submission FDA APPROVAL REQUIRED Typically via premarket(PMA) approval process
  • 34. 34 3. PREMARKET NOTIFICATION( 510 K) • Letter of substantial equivalence from FDA, required before commercial distribution - safe and effective or substantially equivalent to a legally marketed device 4. PREMARKET APPROVAL (PMA) • Class III Devices are high risk devices, so they include the submission of clinical data to support claims made for the device • PMA is the process of scientific and regulatory review to ensure the safety & effectiveness of class III devices 5. INVESTIGATIONAL DEVICE EXEMPTION (IDE) • Allows the Investigational device to be used in a clinical study in order to collect safety and effectiveness data • Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board ( IRB) before the study can begin
  • 35. 35 6.QUALITY SYSTEM REGULATION • Includes methods, facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices to assure compliance. 7.LABELING • Includes labels on the device as well as descriptive and informational literature that accompanies the device 8.MEDICAL DEVICE REPORTING • To detect and correct problems in a timely manner and to identify and monitor significant adverse events involving medical devices.
  • 36. 36 • In India medical devices are governed by CDSCO which is regulated by Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India. • CDSCO is the only government body which regulate the medical devices • Medical devices are regulated by the Drug Controller General of India (DCGI)within the CDSCO • MEDICAL DEVICES CLASSIFIED AS: 1. CLASS A 2. CLASS B 3. CLASS C 4. CLASS D REGULATORY REQUIREMENTS OF MEDICAL DEVICES IN INDIA
  • 37. 37 REGULATORY BODY FOR MEDICAL DEVICES DRUG CONTROLLER GENERAL OF INDIA(DCGI) DEPUTY DRUG CONTROLLER ASSISTANT DRUG CONTROLLER MEDICAL DEVICE CELL DRUG INSPECTOR TECHNICAL DATA ASSOCIATE DIAGNOSTIC DRUG INSPECTOR TECHNICAL DATA ASSOCIATE
  • 38. 38 FUNCTION OF MEDICAL DEVICE CELL Import, registration and licensing of medical devices Approval of new medical devices Manufacturing license to indigenous manufacturer under CLAA scheme Grant of test license NOCs for import Neutral code for export Clinical trials
  • 39. 39 APPROVAL PROCESS DETERMINE IF THE PRODUCT REQUIRES REGISTRATION APPOINT AUTHORISED INDIAN AGENT SUBMIT THE REGULATORY DOSSIER UNDER FORM 40 OBTAIN REGISTRATION CERTIFICATE IN FORM 41 OBTAIN IMPORT LICENSE IN FORM 10(VALID UPTO 3 YEARS) MARKETING IN INDIA
  • 40. 40 •STATE LICENSING AUTHORITY FOR CLASS A & B MEDICAL DEVICE •CENTRAL LICENSING AUTHORITY FOR CLASS C & D MEDICAL DEVICES REGISTRATION OF MEDICAL DEVICES
  • 41. 41 MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION CLASS A CLASS B CLASS C CLASS D APPLICATION-ONLINE PORTAL OF THE MINISTRY OF HEALTH AND FAMILY WELFARE(SUGAM) SCRUTINY BY STATE LICENSING AUTHORITY(SLA) SCRUTINY BY CENTRAL LICENSING AUTHORITY(CLA) LICENSE TECHNICAL REVIEW(4TH SCHEDULE) AND ONSITE AUDIT(5TH SCHEDULE) BY NOTIFIED BODY TECHNICAL REVIEW(4TH SCHEDULE) AND ONSITE AUDIT(5TH SCHEDULE) BY CLA MAY AVAIL SERVICE OF A NOTIFIED BODY OR AN EXPERT LICENSE
  • 42. 42 INDIAN MEDICAL DEVICE REGULATORY ACT(IMRDA) Indian Medical Devices Regulatory Act come in force December 31, 2009 Central Government Eminent Jurist Two eminent medical practitioners Two eminent medical technologists Secretary General Quality council COMPOSITION OF THE COMMITTEE
  • 43. 43 OBJECTIVES OF IMRDA Provide notification of essential principles Provide for risk based classification of device Notify standards and guidelines Provide mechanism of conformity Provide a post market surveillance system Provide for enforcement IMRDA ESSENTIAL PRINCIPLES •Should not compromise health and safety. Design and manufacture of devices must conform with safety principles. Long term safety should be ensured. Benefits of the devices must outweigh any side effects. Medical devices should be useful for the intended purpose.
  • 44. 44 IMRDA-THE REGULATION Will issue: 1.Design and manufacturing requirements. 2.Performance evaluation. 3.Demonstration of device standards, testing and compliance. 4.Regulation of post marketing follow up. 5.Regulation of recalls. 6.Legislate and punishment for non compliance. 7.Principle of safety.
  • 46. 46 • Liaison means Communication or Co-operation. • Every Pharmaceutical industry must follow some of the regulations held by its higher authorities. • FDA also lays some of the regulations in order to maintain the quality and safety of drugs and pharmaceutical products. • Effective communication should be maintained between Pharmaceutical Industries and FDA. INDUSTRY AND FDA LIAISONS
  • 47. 47 FDA(FOOD AND DRUG ADMNISTRATION) • The Food and drug Administration (FDA) is one of the oldest consumer protection agency. • FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug and Cosmetic Act and several related public health laws • FDA ensures the safety, efficacy and security of human and veterinary drugs, biological products and medical devices • Also ensure the safety of food supply, cosmetics and products that emits radiation
  • 48. 48 RESPONSIBILITIS OF FDA • Food safety and Dietary supplements • Animal foods and feeds • Tobacco products • Prescription and other OTC drugs • Vaccines and Biopharmaceuticals • Blood transfusions • Medical devices • Cosmetics • Veterinary products FDA is responsible for protecting and promoting public health through control and supervision of the following categories
  • 50. 50 1.INSPECTIONS & LEGAL SANCTIONS •They ensures that the products are made correctly and labeled truthfully. •They collect about 80,000 domestic and imported product samples for examination by FDA scientists for for label checks. •If a company is found violating any of the laws, the FDA can encourage the firm to correct the problem voluntarily or to recall a faulty product from the market. •When a company cannot or will not voluntarily correct the problem with one of its products, the FDA has legal sanctions it can bring to bear.
  • 51. 51 2.SCIENTIFIC EXPERTISE •The scientific evidence needed to back up the FDA’s legal cases is prepared by the agency’s 2,100 scientists, including 900 chemists and 300 microbiologists. •Some of these scientists analyze samples and others review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents, and medical devices. •The agency must determine that the new drug produces the benefits it is supposed to without causing side effects that would outweigh those benefits.
  • 52. 52 3.PRODUCT SAFETY •The agency’s scientists test samples to see if any substances, such as pesticide residues, are present in unacceptable amounts. • If contaminants are identified, the FDA takes corrective action. •The safety of blood supply is another FDA responsibility. The agency’s investigators routinely examine blood bank operations, from record-keeping to testing for contaminants. •Cosmetic safety also comes under the FDA’s jurisdiction. The agency can have unsafe cosmetics removed from the market.
  • 54. 54 CENTER AREA OF RESPONSIBILITY CENTER FOR DRUG EVALUATION AND RESEARCH Safety and effectiveness of Prescription and OTC drugs CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Safety and effectiveness of vaccines, nation's blood supply, Biologics CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Safety and effectiveness of Medical devices, diagnostic tests, Radiation emitting devices CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Safety of domestic and imported food supply, cosmetics and dietary supplements CENTER FOR VETERINARY MEDICINE Safety and effectiveness of veterinary drugs CENTER FOR TOBACCO PRODUCTS Implementation of the Family Smoking Prevention and Tobacco Control Act NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH Research to support regulatory decisions and reduce risks associated with FDA regulated products OFFICE OF REGULATORY AFFAIRS Enforcement of Laws and regulations
  • 55. DIVISIONS OF FDA CENTER FOR DRUG EVALUATION & RESEARCH(CDER) CENTER FOR BIOLOGICS EVALUATION & RESEARCH(CBER) CENTER FOR DEVICES AND RADIOLOGICAL HEALTH(CDRH) CENTER FOR FOOD SAFETY & APPLIED NUTRITION(CFSAN) CENTER FOR VETERINERY MEDICINE(CVM) NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH(NCTR)
  • 56. 56 • CDER's mission is to ensure that safe and effective prescription, non- prescription and generic drugs are available to the people as quickly as possible. • CDER fulfills its mission by overseeing the clinical research, development, manufacture, and marketing of drugs. • Responsible for reviewing all INDS, NDAs, and chemistry and efficacy supplemental applications. • CDER ensures that drug labeling, drug information for patients, and drug promotion are truthful, helpful, and not misleading. CENTER FOR DRUG EVALUATION AND RESEARCH(CDER)
  • 57. 57 FUNDAMENTAL GOALS AND OBJECTIVES Promote public health by ensuring the availability of safe and effective drugs Protect public health by promoting the safe use of marketed drugs Protect public health by ensuring the quality and integrity of marketed drug products. CDER ORGANISATION NEW DRUG DEVELOPMENT AND REVIEW POST-MARKET DRUG SURVEILLANCE GENERIC DRUG REVIEW PROCESS OTC DRUG REVIEW
  • 58. 58 • One of CDER's primary goals is to work collaboratively and cooperatively with industry To improve the drug development and review process. • It also strives to provide consumers and health care providers with drug information that is vital for improving the public health. CONTACT WITH FDA VARIOUS MEANS OF COMMUNICATING WITH CDER 1.CONSUMER/INDUSTRY INQUIRIES 2.INDUSTRY/FDA INQUIRIES 3.FDA/INDUSTRY MEETING
  • 59. 59 1.CONSUMER/INDUSTRY INQUIRIES • To enhance the communications aspect of this process, the Center created the Division of Communications Management (DCM). • This division enhances information exchange, strategic communications planning, and the development of communications products and initiatives. • The Division of Communications Management works to ensure that pharmaceutical industry representatives, health care professionals, government officials, and consumers have easy and open access to information and are educated about the drug regulation process and the benefits and risks of drugs.
  • 60. 60 The newest and easiest method for getting information is the Center's world wide web homepage at http://www.fad.gov/cder. For more specific or complex drug inquiries, individuals may telephone the Drug Information Branch or send an electronic mail. For specific inquiries from industry, CDER's Compendia Operations Ways consumers and industry representatives can communicate with the center
  • 61. 61 2.FDA/INDUSTRY MEETINGS • All meetings with the FDA are held at the pleasure of the agency and should be requested judiciously. • Project managers, are responsible for coordinating FDA/industry meetings. • If a meeting with the FDA is deemed necessary, the first step is to telephone the project manager assigned to the firm's IND or NDA. • The need for a meeting should be explained, a statement about the general topic of the meeting should be described, and an idea of when the meeting is needed should be offered.
  • 62. 62 • The project manager will likely return the call and indicate if a meeting will be granted. • If the answer is positive, a confirmatory letter from the firm should be sent to the appropriate division. • The document should include the fact that the meeting has been granted and what the date for the meeting will be. • The names and titles of those representatives of the sponsor who will be attending the meeting, and the proposed agenda are provided.
  • 63. 63 CATEGORIES OF MEETING INDUSTRY CAN REQUEST TO AGENCY TYPES A TYPE B TYPE C TYPE A • Most important. • To dispute issues that arise during new drug development, or to resolve clinical holds that the FDA has deemed necessary. • These meetings are usually scheduled 30 days from FDAs receipt of a written request for a meeting.
  • 64. 64 TYPE B • Usually occur for a pre-IND, an end of phase 1 (EOP1), an end of phase 2 (EOP2), or a pre-NDA or BLA Conference • Usually scheduled 60 days from the time the agency received the written request. TYPE C • Any other meeting not falling into type A or B meetings. • These are meetings that pertain to the review of human drug applications. • These meetings are usually scheduled within 75 days of the agency’s of the written request.
  • 65. 04 10 MARKS 1. Explain the regulatory requirement of medical devices for market authorisation 2. Describe the regulation for combination products and medical devices 5 MARKS 1. Explain FDA liaisons for industries PREVIOUS YEARS QUESTIONS 65
  • 66. 05 1. Regulation of combination product in US, FDA Regulatory Affairs, David Manthus & Douglas J Pisano,3rd edition, pageno:361 2. FDA medical device Regulation, FDA Regulatory Affairs, David Manthus & Douglas J Pisano,3rd edition, pageno:125 3. Regulation of combination product, www.ecfr.gov.in 4. Combination product, www.fda.gov.in 5. Medical device and diagnostics, www.cdsco.gov.in 6. India medical device regulation, www.tuvsud.com 7. New drug approval process, Richard A Guarino,4th edition page no:287 REFERENCES 66