This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties. 

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

I. CONTACTS

An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the Center has taken or is about to take.

A. Total Number Received 

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a total of 414 in 2010. New cases were classified as follows:

Type

2011

2010

2009

Inquiries

201 (44%)

206 (50%)

65 (26%)

Complaints

202 (44%)

171 (41%)

132 (53%)

Disputes

43 (9%)

26 (6%)

53 (21%)

Other

15 (3%)

11 (3%)

-

Total

461

414

250

B. Source of Contacts:

Type

2011

2010

2009

Industry

278 (60%)

269 (65%)

175 (70%)

Consumers

105 (23%)

93 (23%)

42 (17%)

Health Care Providers

33 (7%)

25 (6%)

23 (9%)

Internal employee*

23 (5%)

-

-

Other

22 (5%)

27 (6%)

10 (4%)

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means.

C. CDRH Office

Type

2011

2010

2009

OCD

125 (27%)*

61 (15%)

15 (6%)

OCER

57 (12%)

35 (8%)

15 (6%)

OC

61 (13%)

85 (21%)

42 (17%)

ODE

163 (35%)

164 (40%)

135 (54%)

OIVD

32 (7%)

41 (10%)

10 (4%)

OMO

0 (0%)

1 (0.2%)

5 (9%)

OSEL

5 (1%)

0 (0.0%)

5 (2%)

OSB

18 (4%)

27 (7%)

10 (4%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCER: Office of Communication, Education, and Radiation Programs
ODE: Office of Device Evaluation
OIVD: Office of In Vitro Diagnostic Device Evaluation and Safety
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type

2011

2010

2009

510(k) Submission

105 (23%)

138 (33%)

38 (15%)

Adverse Event/MDR/Safety Issue

82 (18%)

70 (17%)

10 (4%)

Combination Product

3 (1%)

4 (1%)

8 (3%)

De Novo Petition

11 (2%)

2 (1%)

13 (5%)

FOIA/Disclosure

5 (1%)

3 (1%)

20 (8%)

Import/Export

25 (5%)

25 (6%)

8 (3%)

Inspection

7 (2%)

12 (3%)

8 (3%)

PMA/IDE/HDE Application

57 (12%)

55 (13%)

23 (9%)

Post-Market Study

8 (2%)

4 (1%)

8 (3%)

Pre-IDE Submission

7 (2%)

9 (2%)

13 (5%)

Registration and Listing Inquiry

19 (4%)

45 (11%)

13 (5%)

Trade Complaint

41 (9%)

28 (7%)

18 (7%)

Other

91 (20%)

19 (5%)

70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type

2011

2010

2009

510(k) Request for Additional Information

21 (5%)

8 (2%)

2 (1%)

Complaint about CDRH employee

6 (1%)

4 (1%)

0 (0%)

Data/Testing Requirements

27 (6%)

43 (10%)

59 (24%)

Level Playing field

16 (3%)

14 (3%)

7 (3%)

Practice of Medicine

29 (6%)

26 (6%)

0 (0%)

Miscommunication/Lack of Communication

111 (24%)

88 (21%)

39 (16%)

PMA Not Approvable

13 (3%)

9 (2%)

1 (0%)

510(k) Not Substantially Equivalent

26 (6%)

21 (5%)

3 (1%)

Policies and Procedures

151 (33%)

193 (46%)

114 (46%)

Registration and Listing

14 (3%)

1 (0%)

3 (1%)

Other

47 (10%)

7 (2%)

22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

F. Year-end Status of Inquiries, Complaints, and Disputes: 

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed as follows:

Type

2011

2010

2009*

Referred to CDRH Subject Matter Expert

65 (13%)

86 (24%)

Email response to inquirer

150 (31%)

83 (24%)

Teleconference

38 (8%)

48 (14%)

Referred to OCER (DSMICA)

41 (8%)

34 (10%)

Closed for inactivity

58 (12%)

27 (8%)

Closed with letter

51 (10%)

13 (4%)

No action requested or required

11 (2%)

13 (4%)

Referred to FDA Ombudsman

16 (3%)

10 (3%)

External meeting with inquirer

12 (2%)

8 (2%)

Referred to another Center within FDA

21 (4%)

7 (2%)

Referred to another Agency

7 (1%)

7 (2%)

Internal meeting

8 (2%)

2 (1%)

Other

9 (2%)

14 (4%)

* closure type was not tracked in 2009

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Approval Application (PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request of the parties.