Department of Health and Human Services
 
OFFICE OF 

 
INSPECTOR GENERAL 

 
 
 
 
 
 
 
 
S   D
CIENTIFIC  ISAGREEMENTS 

 
R M D  
EGARDING  EDICAL  EVICE 

 
 
R D  
EGULATORY  ECISIONS 

 
Daniel R. Levinson 
  
Inspector General
  
 
June 2012 

OEI-01-10-00470 
  
EXECUTIVE SUMMARY:  SCIENTIFIC DISAGREEMENTS REGARDING 
MEDICAL DEVICE REGULATORY DECISIONS 
OEI-01-10-00470 
 
 
WHY WE DID THIS STUDY 
 
The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and 
effectiveness of medical devices and other products.  At the Center for Devices and 
Radiological Health (CDRH), a series of scientific disagreements received media attention 
between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed 
over whether medical devices under review met applicable review standards.  In October 
2009, CDRH issued new policies and procedures for resolving internal scientific 
disagreements related to regulatory decisions.   
 
HOW WE DID THIS STUDY  
 
We surveyed CDRH managers and reviewers, requesting that they identify scientific 
disagreements that occurred during the fiscal year 20082010 period.  We then reviewed the 
administrative files related to 36 reported scientific disagreements for the same period.  We  
also surveyed respondents about their awareness of and training on CDRHs new policies and 
procedures for addressing scientific disagreements.  
 
WHAT WE FOUND 
 
Of the 36 reported scientific disagreements, 3 occurred after October 2009, and the new 
procedures were used to resolve them. The nature and resolutions of these 36 disagreements 
varied widely.  Scientific disagreements often involved multiple issues, and most of their 
resolutions did not lead directly to the approval or clearance of devices.  Most administrative 
files related to scientific disagreements contained required documentation, although 
accountability for file completeness is unclear.  In addition, not all of CDRHs managers and 
reviewers have received training on the new procedures.  CDRH also faces broader challenges 
in identifying and resolving scientific disagreements because of uncertainty about regulatory 
definitions and processes and staff perceptions about expressing differences of opinion. 
 
WHAT WE RECOMMEND 
 
We recommend that FDA:  (1) define more clearly its requirements for documenting and 
resolving scientific disagreements, (2) train all reviewers and managers on the new policies 
and procedures for resolving scientific disagreements, and (3) more clearly assign 
accountability for the contents of the administrative files of all submissions.  FDA concurred 
with our three recommendations. 
 
 
     
 
TABLE OF CONTENTS 
 
Objectives ....................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................8 

Findings......................................................................................................11 
 
At least 36 device submissions had reported scientific 

disagreements from FY  2008 through FY 2010 ............................11 
 
The nature and resolutions of CDRHs reported scientific 

disagreements varied widely ..........................................................12 

Most administrative files related to scientific disagreements 

contained required documentation .................................................14 

Not all of CDRHs managers and reviewers received training       

on the new scientific disagreement procedures .............................15 

CDRH faces challenges in identifying and resolving scientific 

disagreements  ................................................................................17 

Recommendations......................................................................................20 

Agency Comments and Office of Inspector General Response .....22 

Appendix A:  Agency Comments ..............................................................23 

Acknowledgments......................................................................................26 

 
     
OBJECTIVES 
1. 	  To describe the extent and nature of reported internal scientific 
disagreements related to regulatory decisions at the Food and Drug 
Administrations (FDA) Center for Devices and Radiological Health 
(CDRH) from fiscal year (FY) 2008 through FY 2010. 
2.	   To determine whether CDRH followed required regulations, policies, 
and procedures when addressing internal scientific disagreements.  
3.	   To assess the extent to which CDRH has implemented its new policies 
and procedures for addressing internal scientific disagreements. 
4.	   To identify challenges CDRH faces in addressing internal scientific 
disagreements. 
BACKGROUND 
The integrity of FDAs process for approving new medical products is 
essential to ensure that the public receives safe and effective products and 
has confidence in the manner in which FDA comes to its approval decisions.  
The President underscored the importance of scientific integrity, including 
the value of open dialogue, in a March 2009 memorandum to the heads of all 
executive departments and agencies.1   
Scientific disagreements among FDA reviewers may arise for many reasons.  
When reviewers are unable to resolve a disagreement through open 
communication, a fair and transparent resolution process is essential to 
ensure scientific integrity.2   At CDRH, a series of scientific disagreements 
initiated by reviewers received media attention between 2008 and 2010.3  In 
these instances, CDRH reviewers and their managers disagreed over whether 
medical devices under review met applicable review standards.4    
In October 2009, CDRH issued new policies and procedures for addressing 
internal scientific disagreements consequential to regulatory decisions.  The 
 
1 
Memorandum  on Scientific Integrity, 74 Fed. Reg. 10671 (Mar. 11, 2009). 
 
2 
FDA regulations describe a general process for resolving internal disputes on significant 

FDA decisions.   21 CFR  10.75.

3 
 G. Harris, Scientists Accuse Agency Officials of Misconduct, The New York Times, 

November 18, 2008; Dissidents at FDA Complain of Inquiry, The New York Times, January 

27, 2009; and Scientists Say FDA Ignored Radiation Warnings, The New York Times 

March 28, 2010. 

4 The U.S. Office of Special Counsel, an independent Federal investigative and prosecutorial 

agency, is investigating allegations from some  of these reviewers that FDA monitored their 

emails related to these disagreements.  See Office of Special Counsel Broadens Investigation 

into FDAs Surveillance of Employees E-mail. Accessed at www.osc.gov on February 22, 

2012. 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   1 
   
guidance defines eligible differences of opinion as consequential to a 
regulatory decision (such as, but not limited to, a product approval, 
clearance ... ) if taking one position on the issue would lead to a different 
decision than taking another position.5  [Emphasis added.] 
CDRH Organizational Structure  
CDRH is one of seven centers at FDA.6  CDRH comprises eight offices 
headed by directors, including the Office of the Center Director.7  Of the 
eight CDRH offices, the principal ones that approve or clear new devices for 
sale in the United States are the Offices of Device Evaluation (ODE) and In 
Vitro Diagnostic Device Evaluation and Safety (OIVD). 
ODE consists of five divisions organized by general medical device types, 
such as cardiovascular or surgical and orthopedic devices.  OIVD consists of 
four divisions organized around diagnostic device types, such as radiological 
or immunology and hematology devices.8   
CDRH has an ombudsman, who reports to the Deputy Center Director for 
Policy and serves as an impartial party to assist in addressing industry 
complaints about CDRH.  The ombudsman also assists in addressing 
scientific disagreements among CDRH employees.  
Medical Device Approval and Clearance 
The Medical Device Amendments of 1976 to the Federal Food, Drug, and 
Cosmetic Act (FFDCA) established a framework for regulating medical 
devices.9  CDRH assigns each type of device one of three regulatory 
classifications (Class I, II, or III) that are based on its intended use and 
potential risk to patients and other end users.  Regulatory control increases 
from Class I to Class III.   The application path for a medical device 
depends on its class and level of risk.  CDRH approves medical devices 
submitted under the Premarket Approval (PMA) process and clears 
medical devices submitted under the Premarket Notification (510(k)) 
 
5 
 FDA, CDRH,  Standard Operating Procedure (SOP) for Resolution of Internal Differences  
of Opinion in Regulatory Decision-Making, October 30, 2009,  4.4, p. 5.  The term  
regulatory decision is not defined in statute or regulations. 
6 
The other FDA centers are the Center for Drug Evaluation and Research, Center for 
Biologics Evaluation and Research, Center for Food Safety and Applied Nutrition, Center for 
Veterinary Medicine, Center for Tobacco Products, and National Center for Toxicological 
Research.  
7 
CDRH Organizational Chart.  Accessed at www.fda.gov on August 11, 2011.
8 FDA  moved its radiological products division from ODE to OIVD in February 2010.     
9 The  Medical Device Amendments of 1976, P.L. 94-295, are codified largely in ch. V of the 
FFDCA,  501573, 21 U.S.C.  351360ccc-2. 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   2 
   
process.10  Under certain circumstances, CDRH may allow manufacturers 
to market a device under a humanitarian use device exemption. 
The PMA Process.  For a medical device that poses a significant risk of 
illness or injury, the manufacturer generally must submit a PMA  
application.11   When submitting a PMA application, a manufacturer must 
present sufficient valid scientific evidence to provide a reasonable assurance 
that a device is safe and effective for its intended use and otherwise meets 
the statutory criteria for approval.12  After CDRH approves a device for 
marketing in the United States, the manufacturer generally must submit a 
supplemental application to CDRH before it makes any change to the device 
that may affect its safety or efficacy.13    
Typically, CDRH reviews safety and effectiveness data from clinical trials 
on human subjects.  CDRH requires a manufacturer to obtain an 
investigational device exemption (IDE) for a device before conducting 
clinical trials that may pose significant risks to humans.14  CDRH reviews 
the IDE application to determine whether the investigational plan, including 
the clinical trial protocol, is sound and human subjects are adequately 
protected. 
The 510(k) Process. The 510(k) process is considered a faster and less 
stringent premarket review process than PMA.15  A submission under the 
510(k) process must demonstrate that the device in question is substantially 
equivalent to a legally marketed device that is not subject to the PMA  
process (predicate device).16  Most 510(k) submissions do not require 
clinical trial data.17  
CDRH clears a device for marketing if it determines that the submitted 
device has the same intended use and technological characteristics as the 
 
10 
Most Class I devices are low-risk medical devices, such as tongue depressors and manual 
stethoscopes, and are exempt from FDAs premarket notification  requirements.  See FDA, 
CDRH,  Learn If a Medical Device Has Been Cleared by FDA for Marketing. Accessed at  
www.fda.gov on December 7, 2011.   
11
21 CFR  814. Class III devices must be reviewed through the PMA process unless they are 
 
substantially equivalent to a device introduced to the U.S. market before May 28, 1976.  

These Class III devices may be reviewed through the 510(k) process until FDA requires their
  
manufacturers to submit PMA applications.  See FDA, CDRH, General and Special Controls. 

Accessed at www.fda.gov  on December 7, 2011. 

12 
FFDCA,  515(d)(2); 21 CFR  814.44(d)(1) and 814.45(a).

13 
21 CFR  814.39(a). 

14 
21 CFR Part 812.  FDA regulations permit a device manufacturer, under certain
  
circumstances, to support a PMA with clinical trial data obtained from trials not conducted 

under an IDE. 21 CFR  814.15. 
    
15 
21 CFR pt. 807, subpart E. 

16 
21 CFR  807.87 and 807.92(a). 

17  FDA, CDRH, Device Advice:  Investigational Device (IDE).  Accessed at www.fda.gov on 

December 7, 2011. 
 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   3 
   
predicate device. A device with technological characteristics that differ from  
those of the predicate device may also be declared substantially equivalent if 
the information in the 510(k) submission demonstrates that the device is at 
least as safe and effective as the predicate and does not raise additional 
questions of safety and effectiveness.18  
Humanitarian Use Device Exemption. Manufacturers may also receive 
approval to market their devices under the humanitarian use device 
exemption.  This exemption is for medical devices designed to treat rare 
diseases or conditions.19    
Product Review Timelines.   The Medical Device User Fee Amendments 
Act of 2007 (MDUFA II) reauthorizes FDA to collect user fees for medical 
device applications and identify appropriate timelines for the review of  
some product submissions.20   The review times vary by application type, 
ranging from 60 days for some PMA supplemental applications to 295 
days for some PMAs.21  If the device manufacturer submits an incomplete 
application, CDRH may send a letter to the manufacturer requesting 
additional information and place the review on hold while it awaits a 
response. 
Potential Scientific Disagreements That May  Affect Regulatory  
Decisions 
For each type of regulatory decision, such as the approval of a PMA  
application or clearance of a 510(k) submission, multiple CDRH reviewers 
and managers, often with different backgrounds and training, analyze data 
presented by the applicant. Reviewers and managers make 
recommendations or take regulatory action on the basis of their 
interpretations of those data. A difference of opinion among FDA reviewers 
or managers is always possible.  
For example, CDRH reviewers and managers could disagree on whether:  
	   clinical trial data submitted in a PMA application demonstrate safety 
and effectiveness or   
	   a 510(k) application demonstrates that a device is substantially 
equivalent to a predicate device. 
 
18 
FFDCA,  513(i), and FDA, CDRH, Guidance on the CDRH Premarket Notification 
Review Program, 6/30/86 (K86-3), 510(k) Memorandum #K86-3.  Accessed at www.fda.gov  
on December 7, 2011. 
19  FFDCA,  520(m)(1)(2).    
20  MDUFA II is contained within Title II of the Food and Drug Administration Amendments 
Act of 2007, P.L. 110-85 (Sept. 27, 2007).  MDUFA II does not address IDEs and certain 
PMA supplements.  FDA, FY 2010 Performance Report to Congress Medical Device User  
Fee Amendments of 2007.  Accessed at www.fda.gov  on August 12, 2011. 
21 
Ibid. 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   4 
   
 
A scientific disagreement may consist of multiple issues.  For example, 

disagreements over a devices safety could concern all of the following:  

   clinical trial data, 
 
   an engineering aspect of the device, or 

   a manufacturing issue.  

In most instances, CDRH reviewers and managers resolve disagreements 

through discussion and consensus building. 

CDRH Procedures for Resolving Scientific Disagreements  
Administrative Procedures. FDAs regulations provide the basis for 
resolving scientific disagreements by requiring the documentation of 
recommendations and decisions, including significant controversies or 
differences of opinion and their resolutions, and by authorizing internal 
review of decisions.22  FDA regulations require that employees maintain an 
administrative file for every significant regulatory decision (e.g., approval of 
a PMA application).  The administrative file must contain:  
 	  appropriate documentation of the regulatory decision and  
 	  recommendations and decisions of all relevant reviewers and 
managers, including documentation of significant controversies or 
disagreements and their resolutions.23   
FDA regulations also permit FDA employees to request an internal review of 
a decision.24  For example, a branch chief may review the administrative file 
associated with a regulatory decision should he or she have concerns about 
some aspect of the review and may then raise those concerns with the     
next-level manager.   An internal FDA review of a decision must be based 
exclusively on information in the administrative file.25   
CDRH Guidance Prior to October 2009. This guidance for resolving 
scientific disagreements encouraged reviewers to consult with their 
supervisors during a device review.26  If a supervisor disagreed with the 
conclusions or recommendations of a review, he or she could not order 
changes. Instead, the supervisor was required to discuss the disagreement 
with the reviewer.  The guidance provided that if the disagreement was 
resolved through discussion, a memorandum (overturn memorandum) could 
 
22
 21 CFR  10.70 and 10.75.

23   
21 CFR  10.70(b). 

24   
21 CFR  10.75(a). 

25 
21 CFR  10.75(d). 

26 
CDRH,  Documentation and Resolution of Differences of Opinion on Product Evaluations, 

Guidance Memorandum G93-1, p. 1, 1993, revised 1996.  This guidance was written by ODE. 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   5 
   
be added to the administrative file, as appropriate, indicating the agreement 
reached.27   
If a reviewer and supervisor could not reach consensus on a review, the 
division director resolved the disagreement by evaluating the review 
package and rendering a decision. If the decision was not scientific in 
nature, the director could make a notation in the file.  If the issues related to 
the substantive scientific evaluation and the director decided to act contrary 
to the recommendation, he or she added a memorandum to the 
administrative file stating the decision  made and its basis.  A reviewer or 
supervisor who disagreed with the decision could appeal to progressively 
higher supervisory levels until the appeal reached the FDA Commissioner.28   
CDRH officials told us that reviewers and supervisors used these scientific 
disagreement procedures inconsistently.  
CDRH Guidance Effective October 2009. In January 2009, FDA released an 
agencywide directive to strengthen procedures for addressing internal 
scientific disagreements.29   The directive required each center to establish its  
own disagreement resolution policies and established an FDA-wide appeals 
process for resolving internal scientific disagreements.  CDRH released new 
procedures for resolving scientific disagreements in October 2009.30   
The new procedures provide a formal process for resolving internal 
disagreements consequential to regulatory decisions.  The procedures cover 
both the interpretation of scientific evidence to support a decision and the 
interpretation or application of law or policy (scientific disagreements).  A  
scientific disagreement is consequential to a regulatory decision ... if taking 
one position on the issue would lead to a different decision than taking 
another position.31   
The new procedures encourage managers and reviewers to attempt to resolve 
their disagreements through discussion before they invoke the new 
procedures. If a scientific disagreement is not resolved through discussion, a 
reviewer or manager may initiate CDRHs new procedures by writing an 
initiation memorandum outlining his or her position.  The ombudsman 
reviews the memorandum and determines whether it is complete and eligible 
 
27 Ibid., pp. 23.

28 
Ibid., pp. 34.

29 
FDA, FDA Staff Manual Guides, SMG 9010.1 vol. IV, Agency Program Directives, 

General or Multidiscipline Dispute Resolution, Scientific Dispute Resolution at FDA 

(effective January 13, 2009). 
 
30 
CDRH,  Standard Operating Procedure (SOP) for Resolution of Internal Differences of 

Opinion in Regulatory Decision-Making, October 30, 2009.

31
 Ibid.,  4.4, p. 5. 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   6 
   
for the new process.32   This review must be completed within 10 calendar 
days of receipt. A complete initiation memorandum must include: 
 	  the nature of the disagreement, 
 	  the basis for the initiators position, 
 	  any additional information or evaluations needed to resolve the 
disagreement, and 
 	  the initiators recommendation for each issue raised and the basis for 
each recommendation.  
If the ombudsman determines that the initiation memorandum is complete 
and eligible, he or she assigns a manager not involved in the initial 
disagreement to review it.  That manager discusses the disagreement with all 
parties involved and attempts to resolve it.  If the disagreement is resolved, 
the reviewer(s) and manager involved in the disagreement must add a joint 
memorandum to the administrative file documenting both the resolution 
reached and its basis.  
If the parties are unable to resolve the disagreement, the manager must make 
a decision on each disputed issue on the basis of a review of evidence in the 
administrative file and any other relevant resources.  A decision 
memorandum must document efforts made to resolve the disagreement, as 
well as the managers final decision on each issue and its basis.  The 
manager must send the decision memorandum to the ombudsman and all 
parties involved within 30 days of receiving the initiation memorandum.  If 
the manager consults with parties not involved in the disagreement, he or she 
has 45 days to file the decision memorandum.  The decision memorandum 
must be placed in the administrative file.  
If a reviewer or any other involved party is not satisfied with the 
managers decision, he or she may appeal within 10 calendar days for a 
review by a higher supervisory level. Under the procedures, an appealing 
party may continue to appeal the final decision at progressively higher 
supervisory levels until the appeal reaches the Center Director.  Once 
Center action is complete, an appealing party may carry the matter to the 
FDA Commissioner.33  
CDRH tracks only those scientific disagreements that use the new 
procedures and does not track scientific disagreements that have been 
resolved informally, no matter how significant they are.   
 
32 
To be eligible for the disagreement resolution process, the disagreement must be scientific 

and related to a regulatory decision.  

33
 FDA, FDA Staff Manual Guides, SMG 9010.1, vol. IV. 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   7 
   
METHODOLOGY 
Scope 
We reviewed the administrative files related to all reported CDRH internal 
scientific disagreements within ODE and OIVD for the FY 20082010 
period. Our review included disagreements using both the current and 
former policies and procedures.  We did not assess the appropriateness of the 
final decisions.  
Data Sources 
We used four sources of data in our review:  CDRH administrative files; an 
online survey of CDRH reviewers and managers; interviews with CDRH 
officials and other stakeholders; and CDRHs current and former policies, 
procedures, and guidance documents. 
Data Analysis  
CDRH Administrative Files.  Because CDRH did not formally track 
scientific disagreements until FY 2010, when it implemented its new 
procedures, we identified scientific disagreements for the FY 20082010 
period in two ways.   
First, we sent emails to 49 ODE and OIVD managers requesting that they 
identify scientific disagreements that occurred during the FY 20082010 
period. We specified that the managers should include scientific 
disagreements in which: 
   the CDRH guidance prior to October 2009 was used, 
   overturn memorandums were written, or  
   FDAs regulations relating to administrative procedures were used.  
Twenty-four ODE and OIVD managers representing all 9 product review 
divisions responded and identified 25 disagreements for the period of our 
review.  
Second, we surveyed those same managers as well as all reviewers working 
at ODE and OIVD using a questionnaire.  We surveyed only ODE and OIVD 
staff involved in the review of medical devices.  Respondents identified 21 
additional scientific disagreements for the FY 20082010 period, for a total 
of 46. CDRH provided the administrative files for all identified 
disagreements.   
We excluded 10 disagreements from the original 46.  Eight were excluded 
because they occurred outside the scope of our review (one involved 
external rather than internal parties and seven did not occur during the             
FY 20082010 period).  Two of the reported disagreements were duplicates 
of previously reported disagreements and therefore were not reviewed. 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   8 
   
We reviewed 36 administrative files to determine whether scientific 
disagreements were documented in accordance with applicable CDRH 
policies and procedures. Of the 36 scientific disagreements we reviewed,        
33 used the pre-October 2009 procedures or resolved the disagreements 
informally.  Three used the new formal procedures.  
Survey of ODE and OIVD Reviewers and Managers. We surveyed all ODE 
and OIVD reviewers and managers working at CDRH at the time of our 
survey in April 2011.  We developed and used an online survey to determine 
the extent to which ODE and OIVD employees were involved in scientific 
disagreements during the FY 20082010 period.  We also surveyed 
respondents about their awareness of and training on CDRH policies and 
procedures for addressing scientific disagreements.  CDRH reviewed the 
survey and encouraged its reviewers and managers to respond to it.     
CDRH provided the email addresses of 564 reviewers and managers.  We  
excluded eight individuals with invalid email addresses who were no longer 
employed at FDA.  We emailed survey invitations to 556 managers and 
reviewers. We made four attempts via email to obtain responses from ODE 
and OIVD reviewers and managers.  We also gave respondents an 
opportunity to call the Office of Inspector General (OIG) and respond over 
the phone. We received responses from 196 reviewers and managers, a 
response rate of 35 percent.  
Interviews With FDA Officials and Other Stakeholders. We conducted 
structured interviews with CDRH officials and other stakeholders to obtain 
additional context to the administrative file review.  As needed for 
clarification, we interviewed survey respondents who provided contact 
information.    
Review of FDA Policies, Procedures, and Guidance Documents. We  
obtained and reviewed all relevant policies, procedures, and guidance 
documents issued by FDA and CDRH for resolving internal scientific 
disagreements.  
Limitations 
Because CDRH did not track scientific disagreements until FY 2010, we 
requested that ODE and OIVD managers and reviewers identify all scientific 
disagreements during the FY 20082010 period.  Identification was based on 
personal recall. Turnover at CDRH, lack of recall of disagreements that 
occurred, and differing interpretations of what constitutes a scientific 
disagreement may have led to underreporting. 
The response rate for our survey of ODE and OIVD managers and reviewers 
was 35 percent, a rate that CDRH reports is comparable to that of its internal 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   9 
   
surveys. A variety of factors may have contributed to this rate, including 
concerns of reviewers and managers regarding anonymity.   
Because of the response rate, survey responses cannot be generalized to all 
ODE and OIVD managers and reviewers.  The response rate may also have 
contributed to underreporting of scientific disagreements because the survey 
was the only means for reviewers to report them. 
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency. 
   
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   10 
   
 
FINDINGS 
 
At least 36 device submissions had reported
scientific disagreements from FY 2008 through
FY 2010 
CDRH annually processes about 6,000 submissions that require regulatory 
decisions.34  However, CDRH began tracking scientific disagreements only 
in October 2009, when the new formal resolution procedures became 
effective.  It had not tracked scientific disagreements resolved using other 
methods, such as the pre-October 2009 procedures.  The actual number of 
disagreements could well have been higher than 36 because we had to rely  
on the individual recall of reviewers and managers, through an email inquiry 
and online survey, to identify them.  The response rate was 35 percent; 
consequently, it is possible that unreported scientific disagreements occurred 
during the FY 20082010 period.   
Of the 36 submissions with scientific disagreements, 3 used the 
new procedures for resolving them  
CDRHs new procedures provide both a means for formally resolving 
scientific disagreements and a mechanism for tracking and documenting 
them and their resolutions.  CDRH does not require reviewers and managers 
to use the new procedures; the individual parties are, in fact, encouraged to 
resolve the disagreements informally if possible.35   We identified             
nine scientific disagreements that occurred after the new procedures were 
released in October 2009. Of these nine, three used the new procedures and 
six were resolved informally.    
Scientific disagreements involving 510(k) submissions and 
radiological products were most common 
CDRH reviewers and managers reported scientific disagreements for          
19 510(k) and 11 PMA submissions (see Table 1).  As a percentage of 
submissions, 510(k)s were the most common, constituting about 65 percent 
of the estimated 18,000 submissions received during the FY 20082010 
period.36  PMA submissions, including supplements, constituted about  
33 percent of submissions for the 3-year period.     
 
 
34  Based on FY 2010 performance data provided by CDRH.  
35 
CDRH,  Standard Operating Procedure (SOP) for Resolution of Internal Differences of 

Opinion in Regulatory Decision-Making, October 30, 2009, p. 3.

36 
Based on FY 2010 performance data provided by CDRH. 
 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   11 
   
 
Table 1: Number of Medical Device Submissions With Scientific 
Disagreements by Type, FY 20082010    
 
 
Submission Type   Pre-October 2009    October 2009  Total 
 
Procedures Procedures  
510(k)  17  2  19 
 
PMA  11  0  11 
I DE  5  0   5 
Humanitarian use  10   1
 
device exemption  
   Total  33  3  36 
Source:  OIG analysis of CDRH administrative files. 
 
Eleven scientific disagreements involved radiological devices; two of them 
used the October 2009 procedures. The remaining 25 disagreements 
occurred across the other types of medical devices.     
The majority of scientific disagreements (23 of 36) occurred between 
reviewers and their managers (see Table 2).   
 
Table 2: Number of Medical Device Submissions With Scientific 
Disagreements by Involved Parties, FY 20082010  
 
Involved Parties   Pre-October 2009    October 2009  Total 
  Procedures Procedures  
Reviewers and  21  2  23 
  managers 
 
  Peer reviewers   9  9   0
w ithin a single office  
Peer reviewers in   2  1   1
 
two separate offices 
 
  Unable to determine   2  0   2
 
 Total  33  3  36 
 
 
Source:  OIG analysis of CDRH administrative files. 
 
The nature and resolutions of CDRHs reported 
scientific disagreements varied widely  
CDRHs scientific disagreements involved a range of issues and their 
resolutions often did not lead directly to the approval or clearance of the 
medical devices.  About one-third of the resolutions directly led CDRH to 
clear or approve new devices, while the other two-thirds dealt with the 
process prior to final decisions on clearance or approval.  
 
 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   12 
   
Two-thirds of scientific disagreements contained multiple issues 
Of the 36 scientific disagreements we reviewed, 24 involved multiple issues.  
CDRH does not categorize or provide any common nomenclature for the 
types of issues that might cause a scientific disagreement, and managers and 
reviewers did not use consistent terminology to document their concerns.       
Many of the issues involved in scientific disagreements varied according to 
the type of submission, but issues related to device safety and effectiveness 
spanned all submission types.  Disagreements about the 510(k) submission 
process contained the widest range of issues.  These included whether a 
device was eligible for clearance through the 510(k) process, what labeling 
for a device was appropriate, and what predicate device was appropriate. 
Disagreements about PMA submissions included issues related to clinical 
trial design, the need for additional clinical data, and the appropriateness of  
labeling. For IDE submissions, the scientific disagreements related to the 
proposed clinical trial design. 
Two-thirds of the resolutions did not directly lead CDRH to clear or 
approve new medical devices for marketing 
The 36 resolutions spanned all steps of medical device development and 
processing through CDRH and often addressed reviewers needs for 
additional information from the manufacturers.  The development and 
processing of a device includes design and clinical testing; 510(k) or PMA  
application submission; and postapproval activities, such as changes to the 
product. 
Device manufacturers seeking an IDE to conduct clinical trials on humans  
must submit to CDRH the details of proposed clinical trials, including the 
protocols, before they can start trials in the United States.37  Five of the 
resolutions addressed this part of the process.  In one, CDRH reviewers 
disagreed about certain elements of a protocol that was submitted in advance 
of a formal IDE.38   As a result of the resolution, CDRH provided advice to 
the manufacturer on how to revise the protocol before submitting it for 
approval. As a result of the other four resolutions, CDRH approved the trial 
protocols.  In two, CDRH placed conditions on the manufacturers conduct 
of the clinical trials.  
Twenty-five disagreements pertained to applications to clear or approve new 
devices. Of these, 12 resolutions led CDRH to clear or approve the new 
 
37   
 21 CFR pt. 812. 
38  CDRH encourages potential IDE submitters to  consult with it before formally submitting 
an IDE application. CDRH also permits a pre-IDE submission for troublesome parts of the 
IDE application.  CDRH issues a response to a review of a pre-IDE submission within 60 days  
of receipt. See FDA, CDRH, IDE Approval Process.  Accessed at www.fda.gov  on 
December 7, 2011. 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   13 
   
devices. Among the remaining 13, CDRH cleared or approved 2 devices and 
later reversed its decisions after additional review.  In one case, a product 
needed approval from both CDRH and the Center for Drug Evaluation and 
Research because it combined both a device and a drug; CDRH issued 
preliminary approval for that product, but had to revise its decision because 
the Center for Drug Evaluation and Research had not yet approved the drug 
portion.39    
For CDRH to clear or approve a device for marketing, the manufacturer 
must submit a complete application.  In some cases, the review team and 
managers agreed that a 510(k) or PMA application was incomplete, but 
disagreements arose about the type and extent of additional information to 
request. Eight of the twelve resolutions did not result in final decisions on 
the applications, but rather allowed the manufacturers to provide more 
information to CDRH so that the reviews could continue.    
Finally, six scientific disagreements and their resolutions addressed 
supplements to previously approved products.  The resolutions of five of 
these ultimately led CDRH to approve the supplements.  These supplements 
included changes to manufacturing sites, updates to firmware, and new 
indications, among others.  CDRH did not approve one of the supplements.     
Most administrative files related to reported scientific 
disagreements contained required documentation 
Regulations require documentation of scientific disagreements to be 
included in a submissions administrative file.40   The regulations, however, 
do not specify the type of documentation required.  Therefore, we reviewed 
the documentation in the administrative files and characterized the types of 
documents included, e.g., formal memorandums or emails.  Most files 
included documentation of the reported disagreements as required.    CDRH 
has not specified which FDA employee is accountable for ensuring the 
completeness of the administrative file.     
Of the 36 administrative files, 5 lacked documentation  
Of the files with documentation, 22 contained formal memorandums 
documenting the scientific disagreements (see Table 3).                      
Nineteen files contained formal memorandums, as recommended by the  
pre-October 2009 procedures, documenting the reversal of a previous 
decision or recommendation or clarifying a deficiency in the reviewers  
analysis. In addition, three files contained formal memorandums 
documenting disagreements resolved under the new procedures.  In nine 
 
39  A combination product is composed of two or more regulated product types, such as a drug 

and a device. 

40
 21 CFR  10.70(b)(2)(i). 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   14 
   
submission files, emails or other documentation referenced the scientific 
disagreements.  Five files contained no documentation of the disagreements 
or their resolutions.  
 
Table 3: Documentation of Reported  Scientific Disagreements Included in 
 
Administrative Files, FY 20082010 
 
Type of Documentation   Number of Files 
 
Formal memorandum related to pre-October 2009  19 
 procedures 
Formal memorandum related to new procedures  3 
 
(post-October 2009) 
 
Emails or other documents  9 
 No documentation   5
   Total  36 
Source:  OIG analysis of CDRH administrative files. 
 
Reviewers either may not be aware of the requirements to document 
scientific disagreements or may feel pressure from managers to not 
document them.  In response to our survey, 43 of 196 respondents stated that 
they were not aware that regulations require documenting scientific 
disagreements and their resolutions in the administrative files.   
Accountability for completeness of the administrative files is 
unclear 
The regulations for documenting significant decisions in the 
administrative files state that FDA  employees responsible for handling a 
matter are responsible for insuring the completeness of the administrative 
file relating to it.41   We found no documentation that further defined to 
whom this language specifically refers.  In an interview with CDRH 
officials, we attempted to clarify who was responsible for maintaining the 
administrative files.  One official told us that CDRH does not define 
employees responsible for handling a matter, although generally they 
are the lead reviewers on submissions.   
Not all of CDRHs managers and reviewers received 
training on the new scientific disagreement
procedures 
In January 2009, FDA released an agencywide directive to strengthen 
procedures for addressing internal scientific disagreements.  CDRH released 
its new procedures for resolving scientific disagreements in October 2009.  
However, as of April 2011, not all managers and reviewers had been trained.    
Among survey respondents, 87 of 192 reported that they had not been 
trained on the new procedures as of April 2011 (see Table 4).  About half 
 
41  21 CFR  10.70(b). 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   15 
   
of the reviewers that responded said they had not received the training, 
compared to one quarter of managers.42     
 
Table 4: Survey Response by  Position Regarding New  Scientific 
Disagreement Procedures Training  
Training status   Manager  Reviewer 
Trained   25  80 
Not trained  8  79
     Total*   33  159 
*Four persons did not respond to this question. 
Source:  OIG analysis of  survey data.  
 
Furthermore, 65 of 192 respondents reported they did not know how to 
initiate the new scientific disagreement procedures.  Almost all of these    
(64 of 65) were reviewers. 
Of the 105 survey respondents who indicated that they had received training 
on the new procedures, most reported group discussion with managers and 
peer reviewers (see Table 5).  
 
Table 5: Survey Response by Type of New  Scientific Disagreement 
Procedures Training Received    
 
Training type   Respondents 
  Group discussion with manager and/or   57 
peers 
  In person   38 
Informational handouts  37 
 
Internet module  19 
  Other  5 
Note: Respondents could provide more than one training  type. 
Source:  OIG analysis of  survey data. 
 
CDRH provided training on the new procedures through its branches and 
divisions rather than centrally.  Although the training was mandated by 
CDRH and managers were required to report the completion of the training 
by their organizational units, CDRH did not track who received the training.   
Training on the new policies and procedures serves several important 
purposes: (1) to provide an opportunity to highlight the details of the 
policies and procedures, (2) to answer managers and reviewers questions,             
(3) to communicate to managers and reviewers that the topic is important to 
the organization, and (4) to ensure that scientific disagreements are handled 
appropriately.   
 
42
 Of the 87 respondents who reported that they  had not been trained on the new procedures, 
21 had started working at CDRH in 2010 or 2011.  
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   16 
   
CDRH faces challenges in identifying and resolving 
scientific disagreements 
Regulatory decisions at CDRH require the professional judgment of reviewers 
and managers.  However, in some instances, lack of clarity regarding 
definitions or internal processes may contribute to scientific disagreements.  
For example, uncertainty about certain elements of the 510(k) process may 
trigger scientific disagreements.  Regulatory language about scientific 
disagreements leaves room for interpretation regarding what a scientific 
disagreement is and when it must be documented in the administrative file.   
Uncertainty about certain 510(k) regulatory definitions and 
processes may trigger scientific disagreements among CDRH 
reviewers 
Nine of the nineteen 510(k) submissions with disagreements related to 
whether devices were substantially equivalent to predicate devices.  
Determining substantial equivalence to a predicate device requires reviewers 
to exercise professional judgment and scientific expertise.  In five cases, 
reviewers and managers disagreed over whether the intended uses for the 
510(k) devices were the same as those for the predicates.  In three other 
cases, reviewers and managers disagreed over whether certain characteristics 
of predicate devices referenced in the applications made a substantial 
equivalency comparison inappropriate. 
Reviewers and managers also disagreed over whether to request additional 
information from applicants while the submissions were under review.  In 
six cases, reviewers and managers disagreed about this issue, with managers 
recommending that information requests be sent.  For example, in one case, 
the review team and manager disagreed about the appropriate steps after an 
applicant provided an incomplete response to a request for additional 
information.  The review team recommended that the submission be found 
not substantially equivalent, while the manager argued for a second request 
for additional information.  In supporting her recommendation, the manager 
contended that although CDRH had no policy requiring reviewers to give the 
applicant a second opportunity to provide additional information, it was 
good practice. 
To address internal and external concerns regarding the 510(k) review 
process, CDRH conducted a study of its process.  CDRH identified several 
areas for improvement, including (1) a lack of clarity regarding pivotal terms 
defining substantial equivalence; (2) use of predicates that may not be 
appropriate; (3) variations in the expertise, experience, and training of 
reviewers and managers contributing to inconsistency or uncertainty in 
510(k) decisionmaking; and (4) inadequate submissions by some  
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   17 
   
applicants.43  CDRH is taking steps to address these issues.  The Institute of 
Medicine also conducted a review of CDRHs 510(k) process and raised 
concerns about the process in general.44            
Regulatory language addressing the documentation of 
scientific disagreements is unclear 
The new CDRH policy requires documentation of scientific disagreements 
resolved using the new procedures through a written memorandum placed in 
the administrative file.  The FDA regulations that speak to the completeness 
of an administrative file are much broader.   They address the documentation 
of significant decisions in the administrative files and state: [t]he 
recommendations and decisions are to reveal significant controversies or 
differences of opinion and their resolution.45  FDA and CDRH do not 
further define the terms significant controversy and difference of 
opinion, but the regulations do not limit the terms to disagreements that 
invoke the new procedures. One CDRH official told us that no guidance 
explains what constitutes a significant scientific disagreement, adding that  
it would be in the eye of the beholder.   
Of the scientific disagreements we reviewed, 14 were not documented with 
formal memorandums in the administrative files.  It is difficult to determine 
whether the disagreements were not documented because of an oversight on 
the part of the parties involved or whether reviewers considered them too 
minor to warrant formal memorandums.  At least one party to the 
disagreement would have to consider it to be significant to document it for 
the administrative file.  It is also possible that two parties have a scientific 
disagreement that is undocumented because of other reasons.  
Each regulatory decision at CDRH requires an action that incorporates the 
work of many reviewers and their managers, and scientific disagreements 
are inevitable.  CDRH survey respondents reported that scientific 
disagreements are, in fact, common, but are generally resolved through 
open communication, management, and training.46  Such cases do not rise 
to the level of a scientific disagreement that needs to be resolved using the 
new formal procedures.  
 
43  CDRH Preliminary Internal Evaluations  Volume I, 510(k) Working Group:  Preliminary 

Report and Recommendations, August 2010. Accessed at www.fda.gov on 
              
December 11, 2011. 

44 
Institute of Medicine of the National Academies, Medical Devices and the Publics Health: 
 
The FDA 510(k) Clearance Process at 35 Years, 2011.
  
45
 21 CFR  10.70(b)(2)(i).

46  CDRHs new procedures for resolving scientific disagreements reflect this in that they
  
encourage staff to attempt to work out disagreements through discussion prior to initiating the 

formal procedures. 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   18 
   
Reviewers and managers have mixed perceptions about holding 
and expressing differences of opinion 
CDRH policy highlights its goal of supporting a work environment in which 
managers and reviewers are free to express scientific disagreements without 
fear of retaliation. However, some survey respondents expressed concerns 
about doing so: 41 of 196 respondents reported concerns that expressing a 
scientific disagreement to management could adversely affect their careers.  
In addition, six CDRH reviewers reported incidents in which they felt some  
pressure to change elements of their written reviews or to not document a 
scientific disagreement.47  In addition, two reviewers reported that many 
survey recipients would not respond to our survey because they were 
concerned about their anonymity while discussing a sensitive topic.      
In contrast, survey respondents reported more favorably regarding their 
relationships with their peers and managers:  182 of 196 reported feeling 
comfortable discussing scientific disagreements with their peers and 176 
of 196 reported feeling comfortable discussing scientific disagreements 
with their managers. Further, 178 of 196 reported feeling that they had the 
appropriate skill set to discuss scientific disagreements with peers or 
managers.  Lastly, two respondents spoke favorably about CDRHs new 
procedures as a means of addressing scientific disagreements that are not 
resolved through discussion. 
 
47
 These incidents, as reported by the reviewers, occurred both before and during the FY 
20082010 period of our review.    
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   19 
   
RECOMMENDATIONS 
Part of CDRHs mission is to protect the public health by ensuring the safety 
and effectiveness of medical devices.   Toward that end, scientists and 
researchers from multiple disciplines review thousands of submissions every 
year.  Such submissions cover all aspects of a devices life cycle, from the 
design of research protocols, to review and analysis of statistical data from 
clinical trials, to determinations of whether a device was substantially 
equivalent to one that had been approved earlier.   
CDRHs regulatory decisions have significant implications for the publics  
health. Therefore, its processes must ensure the scientific integrity and 
transparency of those decisions. Having robust processes to identify, openly 
discuss, resolve, and document disagreements among multiple reviewers 
contributes to that integrity.  
This evaluation identified 36 scientific disagreements between FYs 2008 and 
2010. Because CDRH did not track scientific disagreements until FY 2010, 
we requested that ODE and OIVD managers and reviewers identify all 
scientific disagreements during the FY 20082010 period.  Turnover at 
CDRH, lack of recall of disagreements that occurred, and differing 
interpretations of what constitutes a scientific disagreement may have led to 
underreporting. 
Each disagreement and its resolution are unique; more than half involved 
multiple points of contention.  Some involved the need for additional data, 
others involved decisions on whether to proceed with the next step in the 
review process, and some involved whether to give final approval or 
clearance. Some concerned the 510(k) process, which presents certain 
challenges known to CDRH not only from this evaluation but also from its 
own review and that of the Institute of Medicine.  CDRH has begun to 
consider its options to improve that process.  
Most of the administrative files related to these disagreements contained 
the required documentation.  However, it was unclear which specific 
employees are responsible for maintaining the administrative files.  
Furthermore, informal disagreements that were resolved without 
employing the new procedures were not always documented for these 
files.  
To strengthen its methods for resolving scientific disagreements, CDRH 
issued new procedures in October 2009.  These procedures are intended to 
help managers and reviewers understand the importance of openly 
discussing and resolving scientific disagreements.  However, the agency has 
not yet trained all of its managers and reviewers on the new procedures, and 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   20 
   
some reviewers report some reluctance to openly discuss or record scientific 
disagreements. 
To address these concerns, we recommend that FDA:  
Define more clearly its requirements for documenting and 
resolving scientific disagreements 
CDRH procedures require a formal process for resolving a disagreement 
when it cannot be resolved informally and is consequential to a regulatory 
decision. The resolution of the disagreement must be documented in the 
administrative file with a written memorandum.  CDRH reviewers and 
managers have used the new procedures only three times since they were 
implemented in 2009.  However, reviewers and managers reported six other 
scientific disagreements that occurred since 2009 when individuals involved 
did not invoke the new procedures. 
FDAs regulations require that the administrative file for every significant 
FDA decision, whether raised formally or informally, contain [t]he 
recommendations and decisions of individual employees and that [t]he 
recommendations and decisions are to reveal significant controversies or 
differences of opinion and their resolution.48 Differences of opinion that are 
resolved informally may still be significant and important to ensuring a 
complete administrative file.  Clarifying the definition of significant 
controversies or differences of opinion and their resolution would help 
CDRH to maximize transparency and ensure that important scientific 
disagreementswhether formally resolved using the new procedures or 
informally resolvedare documented appropriately in the administrative 
files.   
By more clearly defining the term significant controversies or differences 
of opinion, CDRH reviewers and managers could more easily identify 
disagreements that do not invoke the new procedures.  Clarifying the 
definitions would also help reviewers and managers document the 
disagreements and their resolutions more consistently.    
Train all reviewers and managers on the new policies and 
procedures for resolving scientific disagreements 
Mandatory training for reviewers and managers would help to ensure that 
they were aware of the new procedures for resolving scientific 
disagreements.  CDRH could use its existing system for tracking staff 
training to document training on the new procedures.  Mandatory training 
would also raise awareness of scientific disagreements in general and 
communicate the importance of successfully resolving them.   
 
48  21 CFR 10.70(b)(2)(i). 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   21 
   
More clearly assign accountability for the contents of the 
administrative files of all submissions 
Clarifying the definition of FDA  employee responsible for handling a 
matter found in the regulations would improve accountability for 
completeness of the administrative file.  Assigning one member of a 
submissions review team final responsibility for the completeness of the  
file would help ensure that significant scientific disagreements are 
appropriately documented and resolved.    
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
FDA concurs with all three of our recommendations and outlined its plans 
to implement them.   
In response to our first recommendation, FDA stated that CDRH is 
currently revising its standard operating procedures for resolving internal 
scientific disagreements.  It stated that this revision will include 
clarification on the required documentation of scientific disagreements and 
their resolutions. 
In response to our second recommendation, FDA highlighted plans to 
initiate training after CDRH releases its revised procedure.  CDRH will 
track the completion of the training by all reviewers and managers to 
ensure that everyone is trained.     
In response to our third recommendation, FDA stated that CDRH is 
developing new procedures addressing the administrative files and records 
for premarket submissions.  FDA stated that the procedures will include 
assigning accountability for the administrative file.       
The full text of FDAs comments is provided in Appendix A. 
 
 
 
 
 
 
 
 
 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   22 
  APPENDIXA 
AGENCY COMMENTS 
<4
......."""....

""'AR>MENT OF HEALTH AND HUMAN SERVIC" 
Food and Drug Administration 
Silver Spring MD 20993 
Date:  March 28, 2012 
To:  Inspector General 
From:  Acting Associate Commissioner for Policy and Planning 
Subject:  FDA's General Comment to OIG Draft Report on Scientific Disagreements 
Regarding Medical Device Regulatory Decisions 
FDA is providing the attached general comments to the Office ofinspector General's draft report 
entitled, Scientific Disagreements Regarding Medical Device Regulatory Decisions (OE1-01-10
00470). 
FDA appreciates the opportunity to review and comment on this draft report before it is 
published.  . 
David He-.-=D:o--rs-e-y-~-""""----
Attachment 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-1000470)  23   
 
Agency Comments (Continued) 
 
 
   
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   24 

   
Agency Comments (Continued) 
 
 
   
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   25 
   
ACKNOWLEDGMENTS 
This report was prepared under the direction of Joyce M. Greenleaf, 
Regional Inspector General for Evaluation and Inspections in the Boston 
regional office, and Russell W. Hereford, Deputy Regional Inspector 
General. 
Chris Galvin served as the team leader for this study.  Other principal 
Office of Evaluation and Inspections staff from the Boston regional office 
who contributed to the report include Jessica Fargnoli; central office staff  
who contributed include Talisha Searcy.   
 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470)   26 
   
Office of Inspector General

http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, is  
to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the 
health and welfare of beneficiaries served by those programs.  This statutory mission is carried out through 
a nationwide network of audits, investigations, and inspections conducted by the following operating 
components: 
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The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting audits with 
its own audit resources or by overseeing audit work done by others.  Audits examine the performance of  
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intended to provide independent assessments of HHS programs and operations.  These assessments help 
reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. 
Office  of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide HHS, Congress, 
and the public with timely, useful, and reliable information on significant issues.  These evaluations focus 
on preventing fraud, waste, or abuse and promoting economy, efficiency, and effectiveness of  
departmental programs.  To promote impact, OEI reports also present practical recommendations for 
improving program operations.  
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The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of fraud and 
misconduct related to HHS programs, operations, and beneficiaries.  With investigators working in all 
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Department of Justice and other Federal, State, and local law enforcement authorities.  The investigative 
efforts of OI often lead to criminal convictions, administrative sanctions, and/or civil monetary penalties. 
Office  of Counsel to  the Inspector  General  
The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering 
advice and opinions on HHS programs and operations and providing all legal support for OIGs internal  
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