list of Medical device banned in USFDA , reasons for medical device ban, types of medical device ban

1. Department of Regulatory Affairs
Name : S.CHANDRU
Roll No.: RA222225801007
1
SRM College of Pharmacy –
Department of Regulatory Affairs

2.  Medical Device Ban
 Reasons for Medical device bans
 Process does FDA follow for banning
 List of medical devices banned by the USFDA
 Types of medical device ban
 Impact and Post Market Surveillance
 Conclusion
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3. A medical device ban is a total prohibition on the current
and future sales , distribution , and manufacturing of a medical
device.
The FDA has the authority to ban a medical device
intended for human use if it finds, on the basis of all available
data and information, that the device presents a substantial
deception to patients or users about the benefits of the device, or
an unreasonable and substantial risk of illness or injury, which
cannot be corrected by a change in the labeling.
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Department of Regulatory Affairs 3

4. Detailed explanation of reasons for medical device bans
 High risk of injury or death
 lack of clinical evidence
 Safety concern
 Lack of effectiveness
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5.  Identifying and studying the device , analysing the adverse effect ,
risk and benefits posed by alternate device
 Analyzing whether a change in labeling on the device mitigates the
risk .
 Conducting a panel meeting with outside experts.
 Reviewing information from health care professionals and patients.
The FDA can ban a device without actual proof of illness or injury,
and only needs to find that a device has the potential to present
the required degree of risk based on all available data and
information.
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6. The FDA may initiate proceedings to ban the device if:
 the device presents substantial deception in the labeling or an
unreasonable and substantial risk of illness or injury, and
 such deception or risk cannot be, or has not been, corrected or
eliminated by labeling or a change in labeling.
If the FDA decides to initiate proceedings to ban a device, a notice of
proposed rulemaking is published in the Federal Register.
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7. Device Name Date
Electrical Stimulation Devices (ESDs) Used for
Self-injurious or Aggressive Behavior
Effective April 6, 2020
Powdered Surgeon's Gloves, Powdered Patient
Examination Gloves, and Absorbable Powder for
Lubricating a Surgeon's Glove
Effective January 18,
2017
Prosthetic Hair Fibers Effective June 3, 1983
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8. SRM College of Pharmacy –
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9. There are 2 types of medical device ban which
include :
 Proposed Ban
 Final Ban
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10. Proposed Ban :
A Proposed ban is the FDA’s statement of intent to ban a device. The FDA
outlines its assessment of the benefit-risk profile of the device. Specifically, a
proposal to ban a device requires a summary of the:
1. Agency finding unreasonable and substantial risk of illness or injury.
2. Reason why FDA initiated the proceeding
3. Evaluation of data and information obtained under provision of FD&C act
4. Consultation with a panel of experts that classify a device if conducted
5. Determination of reasons why the ban should apply
The Public can comment during the comment period, which is at least 30
days.
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Department of Regulatory Affairs 10

11. Final Ban:
A final ban is the FDA's statement of action and tells the public what
device the FDA is banning and when that ban will go into effect.
The FDA considers any comments it receives on the proposed ban and
determines whether to affirm, modify, or revoke the proposed regulation.
If the proposed regulation is revoked, the FDA will publish a notice to
this effect in the Federal Register.
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12. A Stringent regulatory standards are required to
ensure that the devices are safe, well studied and have
least adverse reactions. A medical device ban is a total
prohibition on the current and future sales,
distribution, and manufacturing of a medical device.
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13.  https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans
(USFDA website )
 https://globalresearchonline.net/journalcontents/v46-2/17.pdf
( Review Article)
 CFR - Code of Federal Regulations Title 21 Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/C
FRSearch.cfm?CFRPart=895
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