Re: FDA hearings - Electroconvulsive therapy machines

[Guest guest]

To comment (hopefully against reclassifying ECT

machines as safe) you can use this easy link and then click the

orange button entitled "Submit A Comment"

http://www.regulations.gov/#%21documentDetail;D=FDA-2010-N-0585-0001

On 1/7/2011 7:34 AM, jeremy9282 wrote:

January 27-28, 2011,

Neurological Devices Panel of the Medical Devices Advisory

Committee Meeting Announcement

Food and

Drug Administration

[Docket

No. FDA-2010-N-0585]

Neurological

Devices Panel of the Medical Devices Advisory Committee; Notice

of Meeting

AGENCY: Food

and Drug Administration, HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee of the Food and Drug

Administration (FDA). The meeting will be open to the public.

Name of Committee:

Neurological Devices Panel of the Medical Devices Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the Agency on FDA's

regulatory issues.

Date and Time: The meeting

will be held on January 27 and 28, 2011, from 8 a.m. to 6 p.m.

FDA

is opening a docket for public comment on this meeting. The

docket number is FDA-2010-N-0585. The docket will open for

public comment on November 26, 2010. The

docket will close on January 25, 2011. Interested persons

may submit electronic or written comments regarding this

meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to

the Division of Dockets Management, Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. Submit a single copy of electronic comments or a

paper copy of any mailed comments, except that individuals

may submit one paper copy. Comments are to be identified

with the docket number found in brackets in the heading of

this meeting notice. Received comments may be seen in the

Division of Dockets Management between 9 a.m. and 4 p.m.,

Monday through Friday.

Location:

Hilton Washington DC North/Gaithersburg, Ballroom, 620

Pkwy., Gaithersburg, MD.

Contact Person:

Engles, Food and Drug Administration, Center for Devices and

Radiological Health, 10903 New Hampshire Ave., Silver Spring,

MD 20993, or FDA Advisory Committee Information Line,

1-800-741-8138 (301-443-0572 in the Washington, DC area), code

3014512513. Please call the Information Line for

up-to-date information on this meeting. A notice in the Federal

Register about last minute modifications that impact a

previously announced advisory committee meeting cannot always be

published quickly enough to provide timely notice. Therefore,

you should always check the Agency's Web site and call the

appropriate advisory committee hot line/phone line to learn

about possible modifications before coming to the meeting.

Agenda: On January 27 and

28, 2011, the committee will discuss and make recommendations

regarding the possible reclassification of devices

indicated for use in electroconvulsive therapy.

FDA intends to make

background material available to the public no later than 2

business days before the meeting. If FDA is unable to post the

background material on its Web site prior to the meeting, the

background material will be made publicly available at the

location of the advisory committee meeting, and the background

material will be posted on FDA's Web site after the

meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Scroll down to the appropriate advisory committee link.

Procedure: Interested persons

may present data, information, or views, orally or in writing,

on issues pending before the committee. Written submissions

may be made to the contact person on or before January 14,

2011. Oral presentations from the public will be scheduled at

approximately 10 a.m., immediately following the FDA's

presentation, on January 27, 2011. Those individuals

interested in making formal oral presentations should notify

the contact person and submit a brief statement of the general

nature of the evidence or arguments they wish to present, the

names and addresses of proposed participants, and an

indication of the approximate time requested to make their

presentation on or before January 6, 2011. Time

allotted for each presentation may be limited. If the number of

registrants requesting to speak is greater than can be

reasonably accommodated during the scheduled open public hearing

session, FDA may conduct a lottery to determine the speakers for

the scheduled open public hearing session. The contact person

will notify interested persons regarding their request to speak

by January 7, 2011.

Persons

attending FDA's advisory committee meetings are advised that the

Agency is not responsible for providing access to electrical

outlets. FDA welcomes the attendance of the public at its

advisory committee meetings and will make every effort to

accommodate persons with physical disabilities or special needs.

If you require special accommodations due to a disability,

please contact AnnMarie , Conference Management Staff,

at 301-796-5966 at least 7 days in advance of the meeting.

FDA is

committed to the orderly conduct of its advisory committee

meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm

for procedures on public conduct during advisory committee

meetings.

Notice of

this meeting is given under the Federal Advisory Committee Act

(5 U.S.C. app. 2).

Dated: November 18, 2010.

Sign: Thinh

Nguyen,

Acting Associate Commissioner for

Special

Medical Programs.

-

[Guest guest]

To comment (hopefully against reclassifying ECT

machines as safe) you can use this easy link and then click the

orange button entitled "Submit A Comment"

http://www.regulations.gov/#%21documentDetail;D=FDA-2010-N-0585-0001

On 1/7/2011 7:34 AM, jeremy9282 wrote:

January 27-28, 2011,

Neurological Devices Panel of the Medical Devices Advisory

Committee Meeting Announcement

Food and

Drug Administration

[Docket

No. FDA-2010-N-0585]

Neurological

Devices Panel of the Medical Devices Advisory Committee; Notice

of Meeting

AGENCY: Food

and Drug Administration, HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee of the Food and Drug

Administration (FDA). The meeting will be open to the public.

Name of Committee:

Neurological Devices Panel of the Medical Devices Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the Agency on FDA's

regulatory issues.

Date and Time: The meeting

will be held on January 27 and 28, 2011, from 8 a.m. to 6 p.m.

FDA

is opening a docket for public comment on this meeting. The

docket number is FDA-2010-N-0585. The docket will open for

public comment on November 26, 2010. The

docket will close on January 25, 2011. Interested persons

may submit electronic or written comments regarding this

meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to

the Division of Dockets Management, Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. Submit a single copy of electronic comments or a

paper copy of any mailed comments, except that individuals

may submit one paper copy. Comments are to be identified

with the docket number found in brackets in the heading of

this meeting notice. Received comments may be seen in the

Division of Dockets Management between 9 a.m. and 4 p.m.,

Monday through Friday.

Location:

Hilton Washington DC North/Gaithersburg, Ballroom, 620

Pkwy., Gaithersburg, MD.

Contact Person:

Engles, Food and Drug Administration, Center for Devices and

Radiological Health, 10903 New Hampshire Ave., Silver Spring,

MD 20993, or FDA Advisory Committee Information Line,

1-800-741-8138 (301-443-0572 in the Washington, DC area), code

3014512513. Please call the Information Line for

up-to-date information on this meeting. A notice in the Federal

Register about last minute modifications that impact a

previously announced advisory committee meeting cannot always be

published quickly enough to provide timely notice. Therefore,

you should always check the Agency's Web site and call the

appropriate advisory committee hot line/phone line to learn

about possible modifications before coming to the meeting.

Agenda: On January 27 and

28, 2011, the committee will discuss and make recommendations

regarding the possible reclassification of devices

indicated for use in electroconvulsive therapy.

FDA intends to make

background material available to the public no later than 2

business days before the meeting. If FDA is unable to post the

background material on its Web site prior to the meeting, the

background material will be made publicly available at the

location of the advisory committee meeting, and the background

material will be posted on FDA's Web site after the

meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Scroll down to the appropriate advisory committee link.

Procedure: Interested persons

may present data, information, or views, orally or in writing,

on issues pending before the committee. Written submissions

may be made to the contact person on or before January 14,

2011. Oral presentations from the public will be scheduled at

approximately 10 a.m., immediately following the FDA's

presentation, on January 27, 2011. Those individuals

interested in making formal oral presentations should notify

the contact person and submit a brief statement of the general

nature of the evidence or arguments they wish to present, the

names and addresses of proposed participants, and an

indication of the approximate time requested to make their

presentation on or before January 6, 2011. Time

allotted for each presentation may be limited. If the number of

registrants requesting to speak is greater than can be

reasonably accommodated during the scheduled open public hearing

session, FDA may conduct a lottery to determine the speakers for

the scheduled open public hearing session. The contact person

will notify interested persons regarding their request to speak

by January 7, 2011.

Persons

attending FDA's advisory committee meetings are advised that the

Agency is not responsible for providing access to electrical

outlets. FDA welcomes the attendance of the public at its

advisory committee meetings and will make every effort to

accommodate persons with physical disabilities or special needs.

If you require special accommodations due to a disability,

please contact AnnMarie , Conference Management Staff,

at 301-796-5966 at least 7 days in advance of the meeting.

FDA is

committed to the orderly conduct of its advisory committee

meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm

for procedures on public conduct during advisory committee

meetings.

Notice of

this meeting is given under the Federal Advisory Committee Act

(5 U.S.C. app. 2).

Dated: November 18, 2010.

Sign: Thinh

Nguyen,

Acting Associate Commissioner for

Special

Medical Programs.

-

[Guest guest]

To comment (hopefully against reclassifying ECT

machines as safe) you can use this easy link and then click the

orange button entitled "Submit A Comment"

http://www.regulations.gov/#%21documentDetail;D=FDA-2010-N-0585-0001

On 1/7/2011 7:34 AM, jeremy9282 wrote:

January 27-28, 2011,

Neurological Devices Panel of the Medical Devices Advisory

Committee Meeting Announcement

Food and

Drug Administration

[Docket

No. FDA-2010-N-0585]

Neurological

Devices Panel of the Medical Devices Advisory Committee; Notice

of Meeting

AGENCY: Food

and Drug Administration, HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee of the Food and Drug

Administration (FDA). The meeting will be open to the public.

Name of Committee:

Neurological Devices Panel of the Medical Devices Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the Agency on FDA's

regulatory issues.

Date and Time: The meeting

will be held on January 27 and 28, 2011, from 8 a.m. to 6 p.m.

FDA

is opening a docket for public comment on this meeting. The

docket number is FDA-2010-N-0585. The docket will open for

public comment on November 26, 2010. The

docket will close on January 25, 2011. Interested persons

may submit electronic or written comments regarding this

meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to

the Division of Dockets Management, Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. Submit a single copy of electronic comments or a

paper copy of any mailed comments, except that individuals

may submit one paper copy. Comments are to be identified

with the docket number found in brackets in the heading of

this meeting notice. Received comments may be seen in the

Division of Dockets Management between 9 a.m. and 4 p.m.,

Monday through Friday.

Location:

Hilton Washington DC North/Gaithersburg, Ballroom, 620

Pkwy., Gaithersburg, MD.

Contact Person:

Engles, Food and Drug Administration, Center for Devices and

Radiological Health, 10903 New Hampshire Ave., Silver Spring,

MD 20993, or FDA Advisory Committee Information Line,

1-800-741-8138 (301-443-0572 in the Washington, DC area), code

3014512513. Please call the Information Line for

up-to-date information on this meeting. A notice in the Federal

Register about last minute modifications that impact a

previously announced advisory committee meeting cannot always be

published quickly enough to provide timely notice. Therefore,

you should always check the Agency's Web site and call the

appropriate advisory committee hot line/phone line to learn

about possible modifications before coming to the meeting.

Agenda: On January 27 and

28, 2011, the committee will discuss and make recommendations

regarding the possible reclassification of devices

indicated for use in electroconvulsive therapy.

FDA intends to make

background material available to the public no later than 2

business days before the meeting. If FDA is unable to post the

background material on its Web site prior to the meeting, the

background material will be made publicly available at the

location of the advisory committee meeting, and the background

material will be posted on FDA's Web site after the

meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Scroll down to the appropriate advisory committee link.

Procedure: Interested persons

may present data, information, or views, orally or in writing,

on issues pending before the committee. Written submissions

may be made to the contact person on or before January 14,

2011. Oral presentations from the public will be scheduled at

approximately 10 a.m., immediately following the FDA's

presentation, on January 27, 2011. Those individuals

interested in making formal oral presentations should notify

the contact person and submit a brief statement of the general

nature of the evidence or arguments they wish to present, the

names and addresses of proposed participants, and an

indication of the approximate time requested to make their

presentation on or before January 6, 2011. Time

allotted for each presentation may be limited. If the number of

registrants requesting to speak is greater than can be

reasonably accommodated during the scheduled open public hearing

session, FDA may conduct a lottery to determine the speakers for

the scheduled open public hearing session. The contact person

will notify interested persons regarding their request to speak

by January 7, 2011.

Persons

attending FDA's advisory committee meetings are advised that the

Agency is not responsible for providing access to electrical

outlets. FDA welcomes the attendance of the public at its

advisory committee meetings and will make every effort to

accommodate persons with physical disabilities or special needs.

If you require special accommodations due to a disability,

please contact AnnMarie , Conference Management Staff,

at 301-796-5966 at least 7 days in advance of the meeting.

FDA is

committed to the orderly conduct of its advisory committee

meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm

for procedures on public conduct during advisory committee

meetings.

Notice of

this meeting is given under the Federal Advisory Committee Act

(5 U.S.C. app. 2).

Dated: November 18, 2010.

Sign: Thinh

Nguyen,

Acting Associate Commissioner for

Special

Medical Programs.

-

[Guest guest]

To comment (hopefully against reclassifying ECT

machines as safe) you can use this easy link and then click the

orange button entitled "Submit A Comment"

http://www.regulations.gov/#%21documentDetail;D=FDA-2010-N-0585-0001

On 1/7/2011 7:34 AM, jeremy9282 wrote:

January 27-28, 2011,

Neurological Devices Panel of the Medical Devices Advisory

Committee Meeting Announcement

Food and

Drug Administration

[Docket

No. FDA-2010-N-0585]

Neurological

Devices Panel of the Medical Devices Advisory Committee; Notice

of Meeting

AGENCY: Food

and Drug Administration, HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee of the Food and Drug

Administration (FDA). The meeting will be open to the public.

Name of Committee:

Neurological Devices Panel of the Medical Devices Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the Agency on FDA's

regulatory issues.

Date and Time: The meeting

will be held on January 27 and 28, 2011, from 8 a.m. to 6 p.m.

FDA

is opening a docket for public comment on this meeting. The

docket number is FDA-2010-N-0585. The docket will open for

public comment on November 26, 2010. The

docket will close on January 25, 2011. Interested persons

may submit electronic or written comments regarding this

meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to

the Division of Dockets Management, Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. Submit a single copy of electronic comments or a

paper copy of any mailed comments, except that individuals

may submit one paper copy. Comments are to be identified

with the docket number found in brackets in the heading of

this meeting notice. Received comments may be seen in the

Division of Dockets Management between 9 a.m. and 4 p.m.,

Monday through Friday.

Location:

Hilton Washington DC North/Gaithersburg, Ballroom, 620

Pkwy., Gaithersburg, MD.

Contact Person:

Engles, Food and Drug Administration, Center for Devices and

Radiological Health, 10903 New Hampshire Ave., Silver Spring,

MD 20993, or FDA Advisory Committee Information Line,

1-800-741-8138 (301-443-0572 in the Washington, DC area), code

3014512513. Please call the Information Line for

up-to-date information on this meeting. A notice in the Federal

Register about last minute modifications that impact a

previously announced advisory committee meeting cannot always be

published quickly enough to provide timely notice. Therefore,

you should always check the Agency's Web site and call the

appropriate advisory committee hot line/phone line to learn

about possible modifications before coming to the meeting.

Agenda: On January 27 and

28, 2011, the committee will discuss and make recommendations

regarding the possible reclassification of devices

indicated for use in electroconvulsive therapy.

FDA intends to make

background material available to the public no later than 2

business days before the meeting. If FDA is unable to post the

background material on its Web site prior to the meeting, the

background material will be made publicly available at the

location of the advisory committee meeting, and the background

material will be posted on FDA's Web site after the

meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Scroll down to the appropriate advisory committee link.

Procedure: Interested persons

may present data, information, or views, orally or in writing,

on issues pending before the committee. Written submissions

may be made to the contact person on or before January 14,

2011. Oral presentations from the public will be scheduled at

approximately 10 a.m., immediately following the FDA's

presentation, on January 27, 2011. Those individuals

interested in making formal oral presentations should notify

the contact person and submit a brief statement of the general

nature of the evidence or arguments they wish to present, the

names and addresses of proposed participants, and an

indication of the approximate time requested to make their

presentation on or before January 6, 2011. Time

allotted for each presentation may be limited. If the number of

registrants requesting to speak is greater than can be

reasonably accommodated during the scheduled open public hearing

session, FDA may conduct a lottery to determine the speakers for

the scheduled open public hearing session. The contact person

will notify interested persons regarding their request to speak

by January 7, 2011.

Persons

attending FDA's advisory committee meetings are advised that the

Agency is not responsible for providing access to electrical

outlets. FDA welcomes the attendance of the public at its

advisory committee meetings and will make every effort to

accommodate persons with physical disabilities or special needs.

If you require special accommodations due to a disability,

please contact AnnMarie , Conference Management Staff,

at 301-796-5966 at least 7 days in advance of the meeting.

FDA is

committed to the orderly conduct of its advisory committee

meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm

for procedures on public conduct during advisory committee

meetings.

Notice of

this meeting is given under the Federal Advisory Committee Act

(5 U.S.C. app. 2).

Dated: November 18, 2010.

Sign: Thinh

Nguyen,

Acting Associate Commissioner for

Special

Medical Programs.

-