This document discusses investigational device exemption (IDE) and post marketing surveillance. IDE allows investigational devices to be used in clinical studies to collect safety and effectiveness data, requiring approval by an institutional review board and FDA for significant risk devices. Post marketing surveillance monitors the safety of medical devices after market release using approaches like spontaneous reporting databases and patient registries to identify potential safety issues and provide long-term monitoring of effects. Both are important parts of ensuring device safety during development and after approval.

1. ‘Investigational Device
Exemption’
and
‘Post Marketing
Surveillance’
Omkar S Chothe
M.Pharm First Year
Drug Regulatory Affairs
Poona College Of Pharmacy, Pune
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2. INVESTIGATIONAL DEVICE
EXEMPTION
(IDE)
Under CFR 21 Part 812
An investigational device exemption (IDE)
allows the investigational device to be used in
a clinical study in order to collect safety and
effectiveness data. (i.e. a device that is the
subject of a clinical study)
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3. •Improving patient access to new medical
devices by strengthening and streamlining the
clinical trial enterprise is a priority for the FDA.
•Investigations covered under the IDE
regulation are subject to differing levels of
regulatory control depending upon the level of
risk.
•The IDE regulation distinguishes between
significant and no significant risk device studies.
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4. Clinical evaluation of devices that have not been
cleared for marketing requires:
•An IDE approved by an institutional review
board (IRB). If the study involves a significant
risk device, the IDE must also be approved by
FDA
(An institutional review board (IRB)- is a type
of committee that applies research ethics by
reviewing the methods proposed
for research to ensure that they are ethical)
•Informed consent from all patients
•Labelling for investigational use only
•Monitoring of the study and
•Required records and reports 4

5. Post Marketing
Surveillance
Under CFR 21 Part 822
It is the practice of monitoring the safety of
a pharmaceutical drug or medical device after it
has been released on the market and is an
important part of pharmacovigilance study.
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6. Post marketing surveillance uses a number of
approaches to monitor drug and device safety,
including-
•spontaneous reporting databases,
• prescription event monitoring,
•electronic health records,
•patient registries, and
• record linkage between health databases.
These data are reviewed to highlight
potential safety concerns in a process known
as data mining.
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7. •Since the drug approval process involves
phase I, II, and III trials, post-marketing trials
are sometimes referred to as phase IV trials.
•PMS provides valuable information on the use
of drugs in patient, which is information not
easily obtainable from pre-marketing studies.
•PMS also allows for long-term monitoring of
the effects of drugs.
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Reference-
•www.fda.gov, CFR 21 Part 812, CFR 21 Part 822
•www.wikipedia.com/clinical Trials