This document provides an overview of FDA regulation of medical devices in the United States. It defines key terms, describes the classification system for devices and corresponding levels of regulatory control. It outlines major premarket and postmarket requirements including establishment registration, 510(k) premarket notification, premarket approval, labeling, quality system regulation, medical device reporting and complaint handling. Major sections cover classification, premarket submissions, labeling and other compliance requirements enforced by the FDA to ensure device safety and effectiveness.

1. FDA REGULATION FOR
MEDICAL DEVICES
Simrana fathima.M
M.Pharmacy
(pharmaceutics)
Regulatory affairs

2. CONTENT
• Definitions
• Classification of devices
• Level of control
• Types FDA regulation
• Establishment registration and device listing
• Premarket notification 510(k)
• Introduction
• substantial equivalence
• Who must submit 510(k)
• content of 510(k)
• when is 510(k) required
• when is 510(k) not required
• De novo classification
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3. • Pre marketed approval
• introduction
• content of PMA
• review of PMA
• PMA supplement
• types of PMA supplement
• IDE(investigational device exemption)
• Pre marketing requirement
• labelling
• label vs labelling
• Post marketing requirement
• quality system regulation/GMP
• Introduction
• Flexibility to QS regulation
• Quality system pyramid
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4. • Medical device reporting
• Mandatory medical device reporting
• Complaint file and medical device reporting
• Reporting an emergency
• Searching medical device report
• The final rule
• Importing medical device.
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5. WHO REGULATES MEDICAL DEVICE
• Australia - Therapeutic Goods Administration (TGA)
• Europe - Certification is obtained from a Notified Body
• USA - Food and Drug Administration (FDA)
• Canada - Health Canada
• China - The State Food and Drug Administration (SFDA)
• Japan - Ministry of Health Labour and Welfare (MHLW)
• Brazil - ANVISA
• INDIA - CDSCO
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6. FDA
The Food and Drug Administration (FDA or USFDA) is
a federal agency of the united states department of Health and
Human service.
MEDICAL DEVICES
The term “medical devices” includes everything from highly
sophisticated computerized medical equipment down to simple
wooden tongue depressors.
COMPUTERIZED MEDICAL EQUIPMENT -- x-ray machine,
ECG machine, pacemaker etc.
"an instrument, apparatus, implement, machine, implant, in vitro
reagent, or other similar or related article, including a
component part, or accessory which comes under the
pharmacopeia.
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7. CLASSIFICATION OF MEDICAL DEVICES
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8. Device Class and Regulatory Controls
1. Class I General Controls
With Exemptions (low risk)
Without Exemptions
2. Class II General Controls and Special Controls
With Exemptions
Without Exemptions
3. Class III General Controls, special control and Premarket
Approval
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9. ESTABLISHMENT REGISTRATION AND
DEVICE LISTING
Establishments required to list their devices include:
• –manufacturers
• –contract manufacturers that commercially distribute the device
• –contract sterilizers that commercially distribute the device
• –repackagers and relabelers
• –specification developers
• –reprocessors of single-use devices
• –remanufacturers
• –manufacturers of accessories and components sold directly to the end user
• –U.S. manufacturers of "export only" devices
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Manufacturer must
register their
organisation with
FDA
Submit electronically
or through an US
agent (must provide
all info about agent)
Verify registration
information every
year( october 1-
dec31)

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11. PREMARKETED NOTIFICATION
INTRODUCTION
Submitter must compare his
medical device with similar
legally marketed device and
prove substantial equivalence
Submitter submits 510(K) to
FDA before marketing
Submitter receives an order in
form of letter from FDA, which
proves that the device is
substantially equivalent.
• All medical devices must submit premarketed
notification, except:- 1.device for which PMA application
is required
2.device exempted from 510(K)
notification FDA (most class I ).
• For Device with 510(K) submission manufacturer must
receive a clearance order before commercial
distribution
• It takes 90 days to receive clearance or longer typically
130 days ( depends on the information submitted by
manufacturer)
• It should demonstrate that the device to be marketed is
as safe and effective as predicate.
• After 510(K) approval the manufacturer can
manufacture the device without waiting for FDA quality
system inspection, but submitter must be ready for
inspection.
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12. SUBSTANTIAL EQUIVALENT
• A device is substantially equivalent only if
1.same use as predicate and same technological
characteristic as predicate.
2.same use as predicate but different technological
characteristic as predicate.
• It confirms that safety and effectiveness are adversely effected
by new technological characteristics.
• If FDA determines that the device is not substantially
equivalent, the applicant may:-
Resubmit another 510(K)
Request class I and class II designation through de novo
process
File reclarification submission
Submit a PMA application
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13. WHO MUST SUBMIT 510(k)
• Domestic manufacturer, specification developer, foreign
manufacturer, must submit 510(K) as they are introducing
medical device to:-
USA market for 1st time
Proposing a new and different use for device already in
commercial use
Changing device already in use
Repacker or relabeller who modify or change the labelling
of medical device.
• 510(K) regulation do not specify who must apply for
510(K)
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14. CONTENT OF 510(k)
• There is no 510(k) form
• But these contents must be present
Device name and class
Substantial equivalent comparison to predicate
Indication for use
Description of device
Performance data
Compliance with standard
Labelling, sterilization and packing
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15. WHEN IS 510(k) REQUIRED
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• When a device is marketed for the 1st time, medical device that
was not marketed before may 28,1976 for these devices 510(K)
is required.
• Propose different use from that of the predicate.
• Change or modification in predicate medical device that affects
the safety and effectiveness
WHEN IS 510(k) NOT REQUIRED
• If unfinished product or components of devices are sold
• If distribute another firms device
• If device is marketed before may 28,1976
• If device is from outside US and the exporter already submitted 510(K),then
the importer need not submit the 510(K).

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17. De novo classification
• Also known as automatic class III designation
• For “low risk” devices with no predicate that are found to
be NSE through the 510(k) process
• Submitter must request de novo classification within 30
days of receipt of NSE
• The de novo process has a 60 day review period.
• If FDA grants request the device is permitted to enter
commercial distribution in same manner as 510(K)
clearance
• Device in DE novo can be used as a predicate in future
510(k) submission.
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18. PRE MARKETED APPROVAL
INTRODUCTION
• Mainly applicable for class III devices ( high risk)
• Applicable for class II if device is not substantially
equivalent.
• Most stringent type of device marketing application
• FDA confirms premarketed approval only when it
confirms the scientific evidence to assure that the device
is safe
• FDA requires 180 days to review or longer
• PMA- private license permitting the applicant to market
the device
• FDA notifies applicant that PMA is approved or denied,
the notice is published on internet also.
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19. CONTENT OF PREMARKETED
APPROVAL
• Device description and principle of operation
• Preclinical and clinical studies
• Bibliography of known information
• Manufacturing information
• Professional and patient labelling
REVIEW OF PMA
• TEAM: medical officer, engineer, biologist, statistian,
labelling expert, manufacturing expert will review
premarketed approval
• 45 days to file and 180 days to review
• Advisory committee input is also required
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20. PREMARKETED APPROVAL
SUPPLEMENT
TYPES OF PMA SUPPLEMENT
• 180 DAYS( in depth review)
• SPECIAL PMA SUPPLEMENT- change being affected
• 30 DAYS NOTICE AND 135 DAYS PMA SUPPLEMENT
(manufacturing process and method)
Submission required
for a change affecting
the safety of device
having PMA
Change must meet
the quality system
requirement

21. INVESTIGATIONAL DEVICE
EXEMPTION (collection of data)
• Allows investigational device to be used in clinical study to
collect data (safety and effectiveness)required to support
a pre marketed approval.
• Investigational device exemption is important for device
which do not get clearance using premarketed approval
REQUIREMENTS TO PROCEED WITH
INVESTIGATIONAL DEVICE EXEMPTION
 plan approved by institutional review board (IRB) for high
risk
Label stating the device is only for investigational use
Monitoring of study
All records and reports
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22. PREMARKETING REQUIREMENT
LABELLING
LABELLING = LABEL+LITERATURE INFORATION OF
DESCRIPTION
LABEL VS LABELLING
label
Display of written, printed, or graphical matter upon immediate
container
Any information appearing on immediate container must also
appear on the wrapper.
LABELLING
All label and other written, printed or graphite matter upon any
article or accompanying such articles
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23. POST MARKETING REQUIREMENT
QUALITY SYSTEM REGULATION/GMP
INTRODUCTION
Quality system specifies the
requirement of method, facilities and
control for medical device life cycle
Manufacturer must follow quality
system to ensure their product has
all the requirement and specification
Quality system for FDA are also
known as current GMPs
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24. FLEXIBILITY OF QUALITY SYSTEM
REGULATION
All manufacturer
must follow the
same regulation
process for
development
Helps the
manufacturer to
ensure that the
device is safe
Manufacturer must
maintain the
regulation process
without any
compromise
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QUALITY SYSTEM PYRAMID
Quality Manual
Quality Procedures
Detailed Work
Instructions
Records, Forms and
Reports

25. MEDICAL DEVICE REPORTING
• A medical device that cause a death, injury or device
malfunction is required to report FDA
• Helps to detect and correct problem of medical device
MANDATORY MEDICAL DEVICE
REPORTING
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28. COMPLAINT FILE AND MDR
• Complaint file are linked to medical device reporting file
because a complaint must be evaluated to determine if it
is a reportable adverse event
• Complaints may be written, oral, or electronic.
• Manufacture and importer must maintain complaint file.
REPORTING AN EMERGENCY: notify FDA office for crisis
management.
SEARCHING MEDICAL DEVICE REPORT: FDA maintain
the MANUFACTURE AND USER FACILITY DEVICE
EXPERIENCE (MAUDE) database. It contains all reports
from august 1996-present.
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29. MDR – FINAL RULE
Medical device
manufacturer, importer need
not submit annual
certification statement
Domestic distributor need
not submit medical device
report, but must maintain
record of adverse events
Submitters now submit the
report annually instead of
semi-annually
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IMPORTING MEDICAL DEVICE
Foreign manufacturer, manufacture the device that emit
radiation and import to US must comply FDA regulation
(before, during and after importing to US).

30. THANK YOU
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