Medtronic Unveils Physician Database, Revised Procedures ...

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CDRH Strives to Strike a Balance Between 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. 23 June 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) INSIDE THIS ISSUE

Transcript of Medtronic Unveils Physician Database, Revised Procedures ...

Page 1: Medtronic Unveils Physician Database, Revised Procedures ...

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

Page 2: Medtronic Unveils Physician Database, Revised Procedures ...

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

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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

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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

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Page 5: Medtronic Unveils Physician Database, Revised Procedures ...

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

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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.

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• 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

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Page 7: Medtronic Unveils Physician Database, Revised Procedures ...

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: Medtronic Unveils Physician Database, Revised Procedures ...

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

Page 10: Medtronic Unveils Physician Database, Revised Procedures ...

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

Copyright © 2010 by Washington Business Information Inc. All rights reserved. Devices & Diagnostics Letter (ISSN 0098-7573) is published weekly, 50issues, for $1,147. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation offederal copyright law and is strictly prohibited without the publisher’s express written permission. Subscribers registered with the Copyright Clearance Center(CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400. For site licenses formultiple users or to purchase multiple copies, contact Content Sales Manager Alka Desai at (703) 538-7669.

Reporters: David Belian, April Hollis, Jim Brocker

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Page 11: Medtronic Unveils Physician Database, Revised Procedures ...

Wait to learn about new FDA mandates and procedures until after an inspection,and you’re risking a Form 483 or a warning letter.

Instead, why not arm your employees with the actual FDA inspection policies andprocedures — before the investigators come knocking?

Order the agency’s own recently-updated manual — Investigations OperationsManual (IOM) 2010. It’s available for purchase from FDAnews.

Changes to the FDA’s inspections are always warily anticipated, and 2010 is no exception. The FDA made dozens of changes to the IOM, including the following areas:

■ New guidance on how the agency will handle inspections of companies with products that have REMS

■ Detailed revisions to the process for field examinations for medical devices

■ New references to Risk Control Reviews and circumstances under which inspectors should use this process

■ Expanded and refined definitions of the way the U.S. Marshals Service and FDA will work together

■ Overhauled and expanded guidance for handling import violations

■ New guidance specifically for investigations that may lead to criminal complaints

■ Direction for inspectors to overcome privacy barriers to accessing information

■ Updated phone numbers, office names, contact information

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Investigations Operations Manual 2010

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Page 12: Medtronic Unveils Physician Database, Revised Procedures ...

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.

With the FDA issuing warning letters at the rate of one-and-a-half per day in 2009 —a 23% increase over 2008 — now isn't the time to face the FDA unprepared!

FDA compliance expert Seth Mailhot has analyzed data from FDA devicemaker warn-ing letters to better understand what problems the FDA most often cites.

He's released his findings in a new, essential report that finds the following areas topped the FDA's most-cited regulations list:

■ CAPA

■ Complaint Files

■ Design Control

With FDA Device Enforcement: An Analysis of Warning Letter Trends, you'll be able to dissect the themes found inrecent FDA warning letters and focus on these topics as you prepare your teamfor an inspection that reflects the agency’s priorities — helping safeguard youfrom 483s, and yes, warning letters too.

All the details are in the exclusive management report, authored by FDA compliance expert Seth Mailhot. In FDA Device Enforcement: An Analysis of Warning Letter Trends, Seth puts his years of experience to work for you to help you understand and interpret the regulations of greatest concern to devicemakers.

FDA Device Enforcement: An Analysis of Warning Letter Trends

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