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FDA Draft .pdf


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Title: https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/
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FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks :: “The Gray Sheet” :: ... Page 1 of 3

Related Articles: 2
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

FDA Drafts Plan To Publicize
'Emerging Signals' Of Device Risks
By Sue Darcey / Email the Author
Regulatory & Policy News / Word Count: 875 / Article # 01160104012 /
Posted: December 30 2015 6:20 PM

Executive Summary
In a draft guidance, FDA explains how it plans to communicate signs of
postmarket device risks before it has performed a full analysis or developed
specific recommendations. Public health advocates say it is a positive move
to get ahead of potential safety problems early. The agency is seeking
comment from companies on whether it needs to consult with firms prior to
releasing information on emerging signals about their devices.

Duodenoscope-Makers Ordered
By FDA To Conduct Sec. 522
Postmarket Surveillance Studies
“The Gray Sheet” Oct. 5, 2015
Planning Board Proposes
Postmarket Device Surveillance
Timeline
“The Gray Sheet” Feb. 23, 2015

Topics Covered in this
Article
Click a keyword for related
articles.
Subjects
Regulatory
Post-Market Regulation
Post-Marketing Studies
Product Recalls
Product Safety
Risk Management
Industries
Medical Devices

FDA maps out a plan to alert patients, providers and the general public about
emerging signals of problems with already cleared or approved devices before the
agency has conducted a full analysis or developed specific recommendations in a
draft guidance
released Dec. 30.
The draft is focused on communicating product risks to the public based on reports
it receives of “unanticipated problems [that] may change the benefit-risk profile of a
device,” the agency said.
“We believe there is a need to notify the public about emerging signals that the
agency is monitoring or analyzing,” the draft states.
FDA defines an "emerging signal" as new information about a medical device used
in clinical practice that might not have been validated or confirmed, and has the
potential to impact patient management decisions. In addition to being extracted
from adverse event reports, the “emerging signals arise from peer-reviewed
literature, personal use of a device, media stories, web blogs, presentations at

Therapeutic Area(s) of Focus
Aesthetics
Cancer
Cardiovascular
Dermatology
Gynecology
Metabolic Disorders
Ophthalmic
Orthopedics
Respiratory
Marketing
Consumer
Homebased
Hospital
Physician Specialty

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/1/fda-drafts-plan-to-p... 12/31/2015

FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks :: “The Gray Sheet” :: ... Page 2 of 3

scientific meetings, as well as from communications from individuals and
stakeholders,” agency spokeswoman Angela Stark told “The Gray Sheet."
“The [draft] guidance addresses an
Emerging signals of device
important problem – the delay between
early signals that a device is less safe or
problems might arise from
less effective than expected, and the
peer-reviewed literature,
confirming evidence that FDA wants to
device-use reports, media
have before making recommendations,”
stories, blogs, scientific
said Diana Zuckerman, a researcher and
presentations and other
president of the National Center for
source, the agency says.
Health Research, in an email.
Zuckerman, a frequent critic of the
agency's oversight of devices, says the
draft guidance is an "important step in the right direction."

Companies
Bayer AG
Bayer Corp.
Bayer HealthCare LLC

What And When To Communicate
According to FDA, an emerging signal could be a newly recognized adverse event;
an increase in severity or frequency of reporting of a known event; new productproduct interactions; device malfunctions or patient injuries related to improper
device use or design; or a reduction in benefit to a patient.
The agency says it intends to share these emerging signals about the safety or
effectiveness of devices on the market with the public “even when the information
has not been fully analyzed” so providers and patients can learn about the potential
benefits and risks of the products.
The draft guidance recommends that FDA consider public communication about an
emerging signal if the information represents a new, potentially causal association
between a device and one or more adverse events or clinical outcomes. Staff
should also consider if the available information is reliable and supported by
sufficient evidence, and whether it could have important clinical implications for
patient management.

Fits With Broader Postmarket Reforms
The draft guidance was developed as part the agency's “overall approach to
improving postmarket surveillance and communications,” FDA spokeswoman Stark
said, noting that it was “not developed in response to any specific device or issue,
but rather clarifies our proposed policy for when we will publicly share information
about emerging signals."
Researchers from Pew Charitable Trusts and the National Center for Health
Research, which routinely analyze the effectiveness of FDA’s device regulations for
patients and consumers, pointed out that the proposed policy might help to more
quickly address issues that have surfaced at several recent device safety events.
Zuckerman wrote that safety issues with
postmarket devices are “a common
problem, and there are numerous
examples: surgical mesh, [power]
morcellators, Essure, metal-on-metal
hips, and duodenoscopes.” (See

The plan would address
delays between early signals
that a device is less safe
than expected, and evidence
confirming that, says Diana

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/1/fda-drafts-plan-to-p... 12/31/2015

FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks :: “The Gray Sheet” :: ... Page 3 of 3

("Duodenoscope-Makers Ordered By
FDA To Conduct Sec. 522 Postmarket
Surveillance Studies" — "The Gray
Sheet," Oct. 5, 2015.)

Zuckerman, National Center
for Health Research.

Essure is a permanent contraceptive device sponsored by Bayer HealthCare LLC
that has triggered thousands of injury reports to FDA.
Josh Rising, director of health programs for Pew, said the proposed emergingsignals policy could be a great application of a national postmarket surveillance
system that FDA and external stakeholders are building. (See "Planning Board
Proposes Postmarket Device Surveillance Timeline" — "The Gray Sheet," Feb. 23,
2015.) They eventually plan to build up a coordinated network of device registries
and a fully working National Device Evaluation System based on Unique Device
Identification information, Rising said. But in the short term, the agency will need to
rely on adverse event reports, imperfect post-approval studies
and existing
device registries to support emerging-signal communications, he noted.
“There’s been a lot of work on postmarket surveillance systems over the past
couple of years," Rising said. "The agency articulated a vision for shifting premarket
data gathering to the postmarket setting. My sense is this effort is part of their
postmarket plans.”
The agency will seek comment from device companies about how, or if, it should
consult with firms prior to releasing information about emerging signals about their
devices, as well as other aspects of the draft guidance, FDA's Stark said.
The comment period is open until March 1, 2016, at docket number FDA-2015-D4803.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

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