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CDRH Strives to Strike a BalanceBetween Risk, Device Innovation
Seeking a balance between risk and innovation, CDRH is in-
vestigating devicemakers’ complaints that it has become too op-
posed to risk while developing an initiative to encourage device in-
novation.
Industry allegations that CDRH is too risk-averse is a new
phenomenon, Jonathan Sackner-Bernstein, associate director of
postmarket operations at CDRH, told D&DL Thursday. To get to
the truth behind the allegations, the center is conducting an inter-
nal inquiry.
“We’re trying to figure out whether there is a pattern that has
emerged recently where we are rejecting things all the time, or
whether it’s being said because of the administrative change or if it’s
people who are upset because they got rejected and are talking about
it,” Sackner-Bernstein said.
Cyberattacks on medical
devices are a critical con-
cern for the VA ........Page 3
FDA is working on a rule to
extend investigator disqual-
ifications ..................Page 3
CDRH leadership could
learn from new policies at
patent office .............Page 5
US regulatory system push-
es devicemakers into inter-
national markets.......Page 6
Trade groups can be con-
duit for information on sup-
plier issues ...............Page 7
FDA sends closeout letters
to HeartSine Technologies
and KHL ..................Page 7
FDA: DexCom should do
more to prevent off-label
uses ..........................Page 9
Covidien to pay $2.6 billion
for Ev3 .....................Page 9
Expert: Supplier agree-
ments should address han-
dling of CAPAs ......Page 10(See Balance, Page 4)
Vol. 37, No. 23June 7, 2010
Medtronic Unveils Physician Database,Revised Procedures on Disclosures
Medtronic paid $15.7 million in royalties and consulting fees to
more than 200 physicians in the U.S. in the first quarter of 2010, ac-
cording to its new physician registry.
The database, available on Medtronic’s website, provides the
company’s first quarterly disclosure of payments it made to physi-
cians. The public registry delivers on a promise the devicemaker
made last year to disclose the names of physicians to whom it made
payments of more than $5,000.
“Collaboration between physicians and industry remains cru-
cial to innovation in the medical technology industry. ... Because
such collaboration is so critical to our mission, it must be based on
solid principles, in order to avoid the potential for real or perceived
(See Disclosure, Page 2)
IINNSSIIDDEE TTHHIISS IISSSSUUEE
conflicts of interest,” Medtronic CEO Bill Hawkins
said in announcing the registry last week.
The database lists physicians alphabetically
and indicates the services they provided in broad
categories: royalties, advisory services, R&D, and
training and education. The database provides ex-
act figures for royalties but only ranges for the
other services. For instance, Kevin Foley of Ger-
mantown, Tenn., was paid nearly $3.97 million in
royalties for his intellectual property contributions
to 10 Medtronic products, including a rod inser-
tion system, a spinal corpectomy device and an
anterior cervical spinal plating system.
However, the database shows David Car-
away of Huntington, W.Va., and Stephen James
of Cumming, Ga., were each paid between
$50,000 to $99,999 for training and education
services.
Policies Revised
Along with the registry, Medtronic unveiled
its updated policies and procedures for working
with physicians, including:
● A standardized needs-assessment process
that verifies and documents the precise busi-
ness need for specific physician services;
● Limitations on the involvement of royalty-
earning physicians in clinical studies and on
the total annual payments that can be made
to individual physicians for providing serv-
ices to the company;
● A standardized services agreement that doc-
uments in advance the services to be provid-
ed by physicians and the fair market value
payment to be made for the services; and
● Systems linking each of these steps with
documentation indicating the physician has
satisfactorily completed the service and in-
voiced for the service prior to payment.
The policy revisions follow months of ex-
amining industry and internal practices, the com-
pany said. As part of its transparency effort,
Medtronic announced last year it was conducting
a broad, comprehensive review of its relation-
ships with physicians and any potential conflicts
of interest.
The announcement came on the heels of a
Senate inquiry into the company’s relationship
with former Army doctor David Polly, who was
accused of failure to disclose that Medtronic had
paid for his trip to testify before a Senate sub-
committee in 2006.
As a researcher at the University of Min-
nesota, Polly allegedly told a university review
committee a Medtronic bone product was the on-
ly commercially available off-the-shelf growth
factor when another product was available, and
he informed Medtronic about study findings be-
fore the information was made public, contrary
to university policy. Medtronic paid Polly more
than $800,000 over a four-year period (D&DL,
Sept. 7, 2009).
However, none of the updated policies was
created in response to a particular physician rela-
tionship, Medtronic spokesman Steven Cragle
told D&DL.
Federal Mandate
The new registry puts Medtronic ahead of a
federal mandate that devicemakers must disclose
any payment or other transfer of value made to a
physician after Dec. 31, 2011. The requirement is
part of the Patient Protection and Affordable Care
Act passed this year (D&DL, April 5).
Once the disclosure requirement kicks in,
Medtronic will have to lower its reporting thresh-
old from $5,000 to $100 to comply with the law.
The necessary adjustments will be made by the
deadline, Cragle said. Medtronic will likely have
to expand its infrastructure to track the additional
transactions, he added.
Medtronic’s physician registry can be ac-
cessed at www.medtronic.com/about-medtronic/
physician-collaboration/physican-registry/index.
htm. — Virgil Dickson, Mari Serebrov
Page 2 DEVICES & DIAGNOSTICS LETTER June 7, 2010
Disclosure, from Page 1
June 7, 2010 DEVICES & DIAGNOSTICS LETTER Page 3
Cyberattacks on DevicesCritical Concern for VA
Veterans Affairs (VA) hospitals are struggling
to protect medical devices from cyberattacks, offi-
cials testified at a House subcommittee hearing.
“Most VA medical facilities were not appro-
priately using network segmentation to restrict
access to their sensitive medical devices,” Belin-
da Finn, assistant inspector general for audits and
evaluations at the VA’s Office of Inspector Gener-
al, told the House Committee on Veterans Affairs
oversight subcommittee.
As a result, she said her office gained unautho-
rized access to sensitive subnetworks while at VA
medical facilities and from remote locations. “The
proper use of network segmentation for restricting
access to sensitive medical devices is critical for the
security and operational stability at VA’s medical
centers,” Finn testified at the recent hearing.
The VA is the largest healthcare provider in
the federal government and has more than 50,000
networked devices, Roger Baker, the VA’s assis-
tant secretary for information and technology, tes-
tified. Hacking is just one concern.
During the past 14 months, more than 122
devices have been compromised by malware,
Baker said. “VA faces a critical challenge in se-
curing our medical devices from cyberthreats —
and securing them is among the highest priorities
for VA,” he added.
One of the biggest challenges to fending off
such attacks is the tight restrictions on applying
patches or implementing malware protection up-
dates on device systems, Baker said. “This inher-
ent vulnerability can increase the potential for cy-
berattacks on the VA’s trusted network by creat-
ing risk to patient safety,” he testified.
To address this concern, the VA last year re-
quired all devices connected to its network to im-
plement a device isolation architecture using a vir-
tual local area network structure. It hopes to have
this completed by the end of the year, Baker said.
In the meantime, the VA’s Office of Informa-
tion Protection Risk Management has initiated a de-
vice protection program to ensure pre-procurement
assessments for medical devices. The program in-
cludes a comprehensive protection strategy encom-
passing communications, training, validation, scan-
ning, remediation and patching for the devices.
The VA’s device security issues were dis-
cussed at a meeting held by the Defense Depart-
ment in April (D&DL, April 19). At that time, the
FDA noted that reports of adverse events stem-
ming from cybersecurity problems are rare.
The FDA is working with the International
Electrotechnical Commission and the Interna-
tional Organization for Standardization to devel-
op an international standard on device security.
— Virgil Dickson
FDA Working on Rule to ExtendDisqualifications Agencywide
The FDA is drafting a proposed rule that
would extend its authority so that clinical investi-
gators disqualified for one type of investigation,
such as devices, would be ineligible to conduct
work on any other FDA-regulated product.
The proposed rule, expected to be released
for comment by the end of the year, is designed
“to help ensure adequate protection of research
subjects and the quality and integrity of data sub-
mitted to FDA,” according to the agency’s Office
of Good Clinical Practice.
The rule will address criticisms outlined in a
Government Accountability Office report that
recommended the FDA amend regulations to ex-
tend its disqualification authority and speed up
its disqualification and debarment process
(D&DL, Oct. 26, 2009).
However, the proposed rule will not address
debarment issues involving devices. While the
FDA has the authority to debar investigators of
drugs and biologics for criminal misconduct, it
cannot debar device investigators as Congress has
yet to give it that authority. — LaCrisha Butler
Some preliminary findings of the inquiry are
included in a report compiled by CDRH’s Task
Force on Utilization of New Science in Regulatory
Decisionmaking that was submitted to center Direc-
tor Jeffrey Shuren last month. The report is expect-
ed to be released to the public this summer (D&DL,
Feb. 15). Further findings from the internal inquiry
will be issued later, Sackner-Bernstein said.
The zero-risk allegations are likely a percep-
tion rather than truth, Sackner-Bernstein said, but
that perception could be a problem for the agency.
“If people view the FDA as opposed to risk,
investors are going to think the agency is just going
to take the easy way out” and reject new devices, he
said. As a result, investors would question the via-
bility of investing in device development in the U.S.
“I’m a U.S. regulator,” Sackner-Bernstein
said. “I want to make sure we have the best tools
and products available in the U.S.”
Devicemakers are starting to see venture
capital go offshore. From 2000 to 2009, venture
capital investment in medical technology grew al-
most 60 percent in Europe and Israel but less
than 40 percent in the U.S., AdvaMed said in tes-
timony presented at a recent meeting of the Presi-
dent’s Council of Advisors on Science and Tech-
nology (D&DL, May 31).
To counter such trends, CDRH is looking for
ways to promote device innovation. One plan is to
launch an innovation initiative similar to the center’s
signal escalation program (D&DL, May 3). But
whereas that program focuses on a risk profile by al-
lowing CDRH staffers in various divisions to moni-
tor information about a single device, the new initia-
tive would use some of the same sources of informa-
tion to monitor innovation, Sackner-Bernstein said
during the keynote address at the Seventh Annual
Medical Device Quality Congress Thursday.
A study released last month showed device-
makers were falling behind other FDA-regulated
industries in terms of innovation. The study attrib-
uted the decline to a widely used business model
focusing on first-of-its-kind devices and longer
approval times at CDRH (D&DL, May 24).
— Virgil Dickson
Page 4 DEVICES & DIAGNOSTICS LETTER June 7, 2010
Balance, from Page 1
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June 7, 2010 DEVICES & DIAGNOSTICS LETTER Page 5
CDRH Leadership Could LearnFrom New Policies at PTO
CDRH could take a few pointers from the
Patent and Trademark Office (PTO) when it comes
to approving submissions in a timely manner.
Not long ago, the PTO was where CDRH is
now — an agency opposed to risk and slow to
approve submissions, Eb Bright, general counsel
and vice president of intellectual property at
ExploraMed, a medical device incubator, said in
a presentation at a recent Medical Device Manu-
facturers Association conference. But things be-
gan to turn around at the PTO when David Kap-
pos was appointed director.
“Kappos comes in and says we can do
things faster then we’re doing them, and we can
still put out quality as long as we measure and in-
centivize the right things,” Bright said.
The progress the PTO has made under Kap-
pos is telling when compared with the situation at
CDRH under Director Jeffrey Shuren, Bright
said, noting that the two men came on board
roughly at the same time.
Not ‘Apples to Apples’
Acknowledging that CDRH and the PTO is
not an apples-to-apples comparison, Bright said
CDRH could implement changes similar to those
Kappos has made, including updating incentives.
Before, the incentive seemed to be for the
PTO examiner and others to drag out the process
and not come to a final decision, Bright said.
Now the reward is geared toward making more
timely decisions.
To reduce a backlog of about 750,000 patent
applications, the PTO began offering applicants a
chance to expedite review of one application in
exchange for withdrawing an unexamined appli-
cation, Bright said. And applications already con-
sidered by a foreign counterpart were pushed
through the U.S. process faster.
As a result of the changes at the PTO, the
number of meetings between applicants and
examiners has increased 60 percent from the
same period last year, Bright said.
But at CDRH, devicemakers are complain-
ing about diminishing time with staff. Scheduling
meetings or conference calls with the agency to
discuss device submissions is more difficult for
companies than in the past, AdvaMed has told
CDRH (D&DL, April 26).
“I think there is opportunity for the leader-
ship in the FDA to step up and say we’re going to
do the right thing,” Bright said.
Some changes that have worked for the PTO
cannot be duplicated at CDRH, Miriam Provost,
former deputy director for science and engineer-
ing review at CDRH’s Office of Device Evalua-
tion, said.
For instance, PTO supervisors are now
working more closely with examiners to help ex-
pedite application review times, she said. But
when CDRH managers took a more active role
with reviewers following passage of the Medical
Device User Fee and Modernization Act, they
were hit with whistle-blower claims that they in-
terfered with staff scientific reviews and recom-
mendations (D&DL, Nov. 24, 2008).
“This whole controversy blew up about
managers doing what you suggest, which is step-
ping in and saying to reviewers, ‘No, I think we
can approve that,’” Provost told Bright. “Because
of that, I can’t see the center changing division
operations any time soon.” — Virgil Dickson
Patent Reform a Headache
Devicemakers could benefit overall from patent reform
legislation, but a post-grant review clause included in
the current bill could cause some headaches.
As written, the clause would allow competitors to re-
peatedly challenge a patent as long as they submit
new evidence, Jeff Grainger, an intellectual property
attorney and managing partner at The Foundry, a
medical device incubator, said at the Medical Device
Manufacturers Association conference.
“There should be some sort of stopgap effect where a
company must raise every issue they ultimately want
to raise in an opposition,” he said. — Virgil Dickson
US Regulatory System PushesIndustry Into Other Markets
Citing slow review times and an increasingly
burdensome regulatory system in the U.S., many
American devicemakers are taking their products
— and their business — to other countries.
Masimo is one device company that began
to expand internationally in answer to slower
510(k) review periods at the FDA. As a result,
every new patient-monitoring device the compa-
ny has made in the past two years has debuted
in Europe, Masimo CEO Joe Kiani said at a re-
cent Medical Device Manufacturers Association
conference.
More companies, especially smaller ones, may
begin to take that route as well, Christopher Row-
land, CEO of NeoTract, a device company focused
on urological and gynecological disorders, predicted.
“Hundreds of companies are struggling try-
ing to do business in the U.S.,” he said at the
conference. “In the meantime, we will find a way
to be competitive outside the U.S.”
For startup companies like his, Rowland
suggested trying to break in to the international
market in Italy, Saudi Arabia, Spain or Turkey
as they have favorable reimbursement policies
and are easier in which to gain traction. The
key to success is finding a good distributor,
he added.
Heading overseas is not without risk, Kiani
cautioned. For instance, the potential for device
plagiarism is high outside the U.S., and interna-
tional patents are a waste of money as they can
be difficult to enforce from country to country,
he added.
When an audience member noted that more
devicemakers are moving their R&D to Asia to
cut costs, Kiani warned, “The Chinese think
copying is an art. Manufacturing there is like a
Trojan horse; it’s really dangerous to do that.”
Expanding internationally is not always an
alternative to FDA approval since some countries
expect a device to be cleared or approved in the
U.S. before they grant marketing authorization,
Kiani said. — Virgil Dickson
Page 6 DEVICES & DIAGNOSTICS LETTER June 7, 2010
Today, your challenge is to use gifts to build relationships without violating the Federal Physician Payment Sunshine provision.
You’ll need expert guidance — because there’s not always a black-and-white answer as to what’s okay and what isn’t.
Meanwhile, since the new federal laws do not preempt stiffer state gift rules, you must clarify what both sets of requirements mean foryour marketing and your compliance efforts.
Let regulatory expert John Patrick Oroho clear up the confusion. Mr. Oroho will clarify what the federal law now requires and how to meshthese requirements with existing state requirements. He will leave no stone unturned in showing you how to protect yourself, including:
• Exactly how the new law applies to gifts of payments to physicians (the reality may be different than what you’ve heard)• 5 tips for avoiding problems as you disclose sampling and payment information• How to plan now for when gift and payment information becomes publicly available• Reporting and disclosure deadlines you don’t want to miss• How to make sure you report no less — and no more — than what’s required• And more
Federal Pharma and Device Physician Gift Law:Confusion Reigns Over New Requirements — State Laws Still Apply
An WebinarThursday, June 17, 2010 • 1:30 p.m. – 3:00 p.m. EDT
Register online at: www.fdanews.com/2923AOr call toll free: (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
June 7, 2010 DEVICES & DIAGNOSTICS LETTER Page 7
Trade Groups Can Be ConduitFor Info on Supplier Issues
Even though the FDA has suggested that de-
vice manufacturers warn each other about suppli-
ers that may be adulterating materials for eco-
nomic gain, legal experts say it’s best to share
this type of information through a trade associa-
tion to protect against liability or antitrust issues.
Any exchange should be limited to historical
facts that could assist members in developing
their own independent policies and practices —
versus exchanging real-time information on terms
or conditions of a devicemaker-supplier agree-
ment, Andre Barlow, a partner with Doyle, Bar-
low & Mazard, told D&DL.
Several recent manufacturing supply chain
problems, including instances of counterfeit or
contaminated heparin from China in 2008 and
2009, could prompt devicemakers to begin
sharing information on supplier quality. And
the FDA has encouraged manufacturers to warn
each other about suppliers and materials that
pose hazards.
However, industry has been reluctant to
share supplier information, Janet Woodcock,
Center for Drug Evaluation and Research direc-
tor, has said. “People’s instinct is to just drop
the supplier and not talk about it,” she noted,
adding that failing to act could damage the in-
dustry’s credibility.
But trading such information among com-
petitors may run afoul of the FTC and contract
law, Barlow said, recommending instead that
trade associations help members share useful
information to establish industry standards.
When these activities are done with adequate
safeguards, they do not pose an antitrust risk,
he added.
Companies should avoid sharing competi-
tively sensitive information that can be used to
fix prices, allocate markets or boycott suppliers,
Robert Doyle, a partner with Doyle, Barlow &
Mazard, said.
Even if shared information about a quality
issue leads to several companies leaving a suppli-
er, “as long as it’s an individual decision and not
a collusive decision, I would say the information
can be shared,” Doyle said.
That doesn’t mean the supplier will not sue,
he said. But if there is a legitimate quality issue
and manufacturers were not trying to influence
other companies’ purchasing decisions, trade as-
sociation members would have an excellent de-
fense, he said. — April Hollis
FDA Sends Closeout LettersTo HeartSine and KHL
HeartSine Technologies has received a
closeout letter from the FDA, officially resolving
a Dec. 10 warning letter.
Although it didn’t get an explanation as to
why it received a warning letter in the first place,
the company welcomed the May 17 closeout let-
ter, Greg Cash, president and CEO of HeartSine,
told D&DL last week.
The warning letter acknowledged that Heart-
Sine’s Aug. 12 response to an inspection of its
Newtown, Pa., facility last summer adequately
addressed the observations cited in the Form 483
issued Aug. 4 (D&DL, May 24). The observa-
tions involved documentation problems. Heart-
Sine makes automatic external defibrillators.
A follow-up inspection was conducted at the
facility in March, Cash said.
The FDA also sent a May 20 closeout letter
to KHL, a gurney maker. The Woodinville,
Wash., company was one of five devicemakers
cited March 17 for failure to submit an annual es-
tablishment registration and device listing infor-
mation for the past two years (D&DL, April 12).
The HeartSine closeout letter is available at
www.fda.gov/ICECI/EnforcementActions/Warning
Letters/ucm212584.htm. KHL’s letter can be found
at www.fda.gov/ICECI/EnforcementActions/Warn
ingLetters/ucm213023.htm. — Mari Serebrov
Page 8 DEVICES & DIAGNOSTICS LETTER June 7, 2010
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June 7, 2010 DEVICES & DIAGNOSTICS LETTER Page 9
FDA: DexCom Should Do MoreTo Prevent Off-Label Uses
Off-label promotion has been a common
theme in recent warning letters to devicemakers,
but the FDA takes it a step further in a letter to
DexCom, telling the company it must do more to
prevent unapproved use of its glucose monitoring
system.
Nowhere in the letter does the agency ac-
cuse DexCom of promoting off-label uses. In-
stead, it notes that the San Diego company knows
its monitoring system is being used in pediatric
patients and in body locations other than the ab-
domen. The company must take action to address
these unapproved uses, the FDA says.
The agency recommends additional warning
statements be included in the device labeling, the
patient education brochure and the company web-
site. For instance, a statement indicating that the
monitoring systems are not approved for use in
certain patients should be strengthened and
moved from the precautions section to the warn-
ings section, the FDA says.
Labeling to Be Revised
Although DexCom believes the FDA’s rec-
ommendations were adequately expressed in the
existing labeling, it says it will revise its labeling
and submit the changes for approval.
The May 21 letter, posted last week, also
raises the issue of just how serious an injury must
be to warrant a medical device report (MDR).
Under 21 CFR 803, companies are required to
submit an MDR within 30 days of learning that a
device has malfunctioned and would be likely to
cause or contribute to a death or serious injury if
the malfunction were to recur.
The FDA points out six complaints of sensor
wire fractures that it says should have triggered
an MDR. In each case, hair-like wires broke off
underneath a patient’s skin. No injuries were re-
ported in a few cases, while others involved skin
irritations. In one complaint, a 3-year-old had
surgery under general anesthesia to remove the
wire. Another toddler had to go to the emergency
room when an infection developed.
The company’s analysis of such complaints
led it to conclude that the events were not re-
portable, DexCom says. However, in its March 2
response to a Form 483, the company agreed to
submit MDRs for all complaints of sensor wire
fractures received after Jan. 1, 2008.
In the warning letter, the FDA reminds Dex-
Com that it must submit a separate MDR for each
event; it cannot group multiple complaints. The
agency also requests documentation of DexCom’s
review of its MDR procedures along with a copy
of the revised procedures.
The letter is available at www.fda.gov/ICE
CI/EnforcementActions/WarningLetters/ucm213
414.htm. — Mari Serebrov
Covidien to Pay $2.6 BillionFor Endovascular Company
To accelerate the growth of its vascular plat-
form, Covidien has signed a merger agreement to
acquire Ev3 for $2.6 billion.
Under the agreement, which has been ap-
proved by the boards of directors for both compa-
nies, Covidien will acquire all of the outstanding
shares of Ev3 for $22.50 per share in cash. The
acquisition is expected to close July 31, Covidien
says.
Founded in 2000, Ev3 develops technolo-
gies and solutions to peripheral vascular and
neurovascular diseases, including plaque exci-
sion systems, angioplasty and occlusion bal-
loons, stents, catheters and embolic protection
devices.
Ev3 will become part of Covidien’s vascular
products line in its medical devices business seg-
ment. The merger is expected to advance innova-
tion in endovascular products and expand Covidi-
en’s presence worldwide, the company says.
— Mari Serebrov
Manufacturer, Supplier AgreementsShould Address Handling of CAPAs
As citations for corrective and preventive
actions (CAPAs) continue to be a leading issue in
FDA warning letters, devicemakers can help pro-
tect themselves by spelling out in supplier agree-
ments how corrective actions should be handled.
Supplier agreements should define how the
devicemaker will transmit a correction request,
specify the intended turnaround time, determine
how the supplier should deal with the correction
and stipulate the type of documentation the supplier
should keep, Dan O’Leary, president of Ombu En-
terprises, said during a recent FDAnews webinar.
If a supplier receives complaints related to a
product it makes for a devicemaker — or for a
similar product — it must notify the devicemak-
er, O’Leary said. Devicemakers may want to en-
ter that information into their complaint manage-
ment system and decide whether to investigate.
Generally in complaint handling, the manu-
facturer would do the investigation as part of its
internal corrective action process.
But in some cases, the investigation should be
done via the supplier’s corrective action process.
In such instances, the supplier will provide all the
skills and legwork and then report back to the
manufacturer on the corrective action that should
be taken.
In handling a complaint, the supplier should
notify the manufacturer if it files a medical de-
vice report (MDR). “You want a copy of the
MDR,” O’Leary told devicemakers. “You don’t
want to stumble across it on the FDA website
when you’re doing your due diligence.”
Manufacturers also need to be informed if a
supplier files a correction or removal involving
the devicemaker’s product or one similar to it, he
noted. The supplier agreement should spell out
how such information will be exchanged.
Other CAPAs may involve issues identified
during supplier inspections, O’Leary said. De-
vicemakers must ensure issues noted during a
supplier audit are corrected in a timely fashion.
He suggested a time frame of five working days.
However, if the supplier wants to prepare a
plan for correction, identify the root cause and
then take corrective action, the process could take
up to 30 days, O’Leary added. That’s why the
supplier agreement should address the timeliness
of corrections.
Suppliers also need to understand the proce-
dures for segregated, investigated disposition of
nonconforming material, according to O’Leary.
It is OK if the supplier reworks or scraps
disposition, he said, noting “rework” means
bringing the product back to full conformance.
But devicemakers must monitor whether the
suppliers are making repair and concession dispo-
sitions as those should not be made without prior
manufacturer approval.
A repaired disposition is a product altered so it
will work, but it no longer follows the specifications.
A concession will not be altered and must be
used as is, O’Leary said. — April Hollis
Page 10 DEVICES & DIAGNOSTICS LETTER June 7, 2010
President: Cynthia Carter; Publisher: Matt Salt; Editorial Director: Pamela Taulbee; Executive Editor: Mari Serebrov
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In this essential new report, you get freshly analyzed data from recent FDA warningletters that will help you understand — in advance — the problems the FDA focuseson and most often cites.
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■ Acceptance Activities
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