FDA proposes more consistent clinical data requirements

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has published a proposed rule that would require medical device clinical studies conducted outside the US in order to support product registrations to be conducted in compliance with Good Clinical Practice (GCP). Part of GCP requires manufacturers using overseas clinical studies in their US registration applications to show proof of review and approval of their studies by Independent Ethics Committees (IEC).

Through the proposed rule, the FDA is seeking to establish consistent clinical data acceptance requirements across all types of medical device applications and submissions, as well as take into account evolving Good Clinical Practice principles.

for complete article, http://www.massdevice.com/blogs/massdevice/fda-proposes-more-consistent-clinical-data-requirements

Flash: IRS releases final guidance on the medical device tax

Flash: IRS releases final guidance on the medical device tax

from MassDevice - FDA and Medical device business news and jobs for the medical device industry by MassDevice staff

 

Internal Revenue Service releases long awaited guidance on the 2.3% medical device excise tax

The IRS has released its final guidance on how the agency intends to regulate and enforce the 2.3% medical device excise tax, slated to go into effect in 2013.
The 58-page report from the federal agency was released Wednesday morning and can be downloaded here.

FDA/CDRH Device Good Manufacturing Practice Advisory Committee (DGMPAC) -Docket No. FDA-2012-N-0001

The FDA's looking for a few good medtech members

 

from MassDevice - FDA and Medical device business news and jobs for the medical device industry by MassDevice staff

The FDA solicits candidates for medical device industry representatives to join the Center for Devices & Radiological Health's Device Good Manufacturing Practice Advisory Committee.

The FDA is seeking written recommendations for candidates to sit on the Center for Devices & Radiological Health's Device Good Manufacturing Practice Advisory Committee, according to a note in the Federal Register.
The federal watchdog agency asked for written recommendations of medical device industry representatives who will hold a non-voting seat on the DGMPAC, a committee tasked with reviewing proposed regulations and making recommendations on medical device manufacturing practices.

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[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71804-71805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Device Good Manufacturing Practice Advisory
Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organization interested in participating in the selection of
nonvoting industry representatives to serve on the Device Good
Manufacturing Practice Advisory Committee (DGMPAC) in the Center for
Devices and Radiological Health notify FDA in writing. A nominee may
either be self-nominated or nominated by an organization to serve as a
nonvoting industry representative. Nominations will be accepted for
current vacancies effective with this notice.

DATES: Any industry organizations interested in participating in the
selection of an appropriate nonvoting members to represent industry
interests must send a letter stating that interest to FDA by January 3,
2013, for the vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by January
3, 2013.

ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993, 301-796-
5960, margaret.ames@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as amended, provides that the DGMPAC
shall be composed of two representatives of interests of the device
manufacturing industry. The Agency is requesting nominations for
nonvoting industry representatives on the DGMPAC.

I. Function of DGMPAC

    Review proposed regulations issuance regarding good manufacturing
practices governing the methods used in, and the facilities and
controls used for manufacture, packaging, storage, installation, and
servicing of devices, and make recommendations regarding the
feasibility and reasonableness of those proposed regulations. The
committee also reviews and makes recommendations on proposed guidelines
developed to assist the medical device industry in meeting the good
manufacturing practice requirements, and provides advice with regard to
any petition submitted by a manufacturer for an exemption or variance
from good manufacturing practice regulations.

II. Qualifications

    Persons nominated for the DGMPAC should possess appropriate
qualifications to understand and contribute to the committee's work as
described in the committee's function.

[[Page 71805]]

III. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations, and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular committee. The interested organizations are
not bound by the list of nominees in selecting a candidate. However, if
no individual is selected within the 60 days, the Commissioner of Food
and Drugs will select the nonvoting member to represent industry
interests.

IV. Application Procedure

    Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from device manufacturing industry.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.

    Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29165 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P

Overview of new medical device regulations in Europe - from MassDevice

By Stewart Eisenhart, Emergo Group
The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs were released by the EU Commission with significant fanfare on 26 September 2012. The weaknesses cited in the Executive Summary/Impact Assessment of the EU regulatory system, were not a shock. The MDEG report (2002) had identified these as areas of concern. In reviewing the changes it became apparent to us there are several themes in the proposed legislation: Oversight of Notified Bodies, Post-market safety, Transparency and traceability, access to external expertise and management of the regulatory system. The impact of the PIP scandal was apparent.

https://www.massdevice.com/blogs/massdevice/overview-new-medical-device-regulations-europe

Medical device groups not giving up on device tax repeal | MassDevice.com On Call

Medical device groups not giving up on device tax repeal | MassDevice.com On Call

from MassDevice - FDA and Medical device business news and jobs for the medical device industry by MassDevice staff

Medical device industry lobby AdvaMed, a vocal opponent of the medical device tax, isn't giving up on repeal as the measure prepares to take effect in in 3 months.

MASSDEVICE ON CALL — Medical device industry lobby AdvaMed isn't going to let regulatory setbacks and the impending onset of the medical device tax discourage its attempts to repeal the levy.
The group plans to continue garnering support for repeal, but has back-up plans in place in case the tax remains in place, AdvaMed CEO Stephen Ubl told an audience at the AdvaMed 2012 MedTech Conference in Boston this week.

Ex-Medicare chief Berwick: "The medical device industry is doing a lot to protect patients"

Erstwhile Centers for Medicare & Medicaid Services chief Dr. Donald Berwick tells MassDevice.com that, despite a clutch of headline-grabbing recalls, medical device makers are doing good work for patients.

Public health pioneer and onetime Centers for Medicare & Medicaid chief Dr. Donald Berwick gave some props to the medical device industry ahead of a presentation at Harvard Medical School this week.
Despite a recent stream of high-profile recalls and the ever-present clamor among consumer groups calling for more stringent regulatory oversight, Berwick said he remains a fan of the industry.
"The medical device industry is doing a lot to protect patients," Berwick told MassDevice.com. "There are people who are alive today who wouldn't be without medical devices."

more...
http://www.massdevice.com/news/ex-medicare-chief-berwick-medical-device-industry-doing-lot-protect-patients

Father sues Intuitive Surgical for botched da Vinci hysterectomy

In a lawsuit filed in a New York court, McCalla said that the da Vinci system burned an artery and intestines during his daughter's surgery, further accusing the surgeon and the hospital of carelessness for not discovering the damage.

McCalla claimed that the surgical robot contains dangerous design flaws, including un-insulated surgical arms that may allow electrical currents to jump to healthy internal organs and tissue. He also said that Intuitive didn't properly train physicians to use the device, according to a press release.

http://www.massdevice.com/news/father-sues-intuitive-surgical-botched-da-vinci-hysterectomy

ACA's Medicaid expansion far smaller than under either Bush

Justice Stephen Breyer seemed unsure of his facts last week.

During oral arguments on the constitutionality of health care reform, he suggested that the law's Medicaid expansion, which will offer government coverage to about 15 million low-wage workers and their families, was smaller than previous expansions – notably, the change of the late 1980s and early 1990s, which brought all poor children under Medicaid's umbrella; and one enacted in the late 1990s and early 2000s that included children up to 200 percent of the poverty level.

"The expansion from 0 to 18 or even 0 to 6 . . . it's pretty hard to argue that they aren't roughly comparable as a percentage of the prior program or as a percentage of GDP (gross domestic product)," he said to Paul Clement, the eloquent litigator who represented the 26 states challenging the Medicaid expansion as unconstitutional coercion of the states. "If I'm right on those numbers, or even roughly right – I don't guarantee them – then wouldn't you have to say, well, indeed, Medicaid has been unconstitutional since 1964?"

http://www.massdevice.com/blogs/massdevice/acas-medicaid-expansion-far-smaller-under-either-bush

If Obamacare falls, MassDevice

http://www.massdevice.com/blogs/massdevice/if-obamacare-falls

Until last week, the government's confidence on the constitutionality of the Patient Protection and Affordable Care Act (PPACA) seemed all but certain. Now, they're not so sure it might stand.
Of course, most American's are wondering: "Okay, if it gets repealed, then what?"
First, it is unlikely things will change right away. Many of the changes we've seen in health care with funding of the electronic medical record and forcing the collaboration between doctors and hospitals were created by the earlier economic "Stimulus" package funding, not the PPACA...

GAO: FDA "inconsistent" in meeting performance goals

March 30, 2012 by MassDevice staff

The FDA met most performance goals between 2003 and 2010, but was inconsistent in its review of pre-market approval applications, especially those marked "expedited," according to a Government Accountability Office report.

The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.

"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."