Department of Health and Human Services
 

OFFICE OF 

INSPECTOR GENERAL 

SCIENTIFIC DISAGREEMENTS 

REGARDING MEDICAL DEVICE 

REGULATORY DECISIONS 

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 2008–2010 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 CDRH’s 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 CDRH’s 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 CDRH’s reported scientific 

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

Most administrative files related to scientific disagreements 

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

Not all of CDRH’s 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 

Administration’s (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 FDA’s 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 FDA’s 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, §§ 501–573, 21 U.S.C. §§ 351–360ccc-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 FDA’s 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. 

1121 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 device’s 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. FDA’s 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. 

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Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470) 6 

 

 

 

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 CDRH’s 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. 2–3. 28 Ibid., pp. 3–4.

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) 7 

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 initiator’s position, 

	 any additional information or evaluations needed to resolve the 

disagreement, and 

	 the initiator’s 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 manager’s 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 

manager’s 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. 
METHODOLOGY 

Scope 

We reviewed the administrative files related to all reported CDRH internal 

scientific disagreements within ODE and OIVD for the FY 2008–2010 

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 CDRH’s 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 2008–2010 

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 2008–2010 

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 

 FDA’s 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 2008–2010 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 2008–2010 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 2008–2010 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 2008–2010 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 
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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 2008–2010 period. 

Of the 36 submissions with scientific disagreements, 3 used the 

new procedures for resolving them 

CDRH’s 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 2008–2010 

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.
 
 Table 1: Number of Medical Device Submissions With Scientific 

Disagreements by Type, FY 2008–2010 

Submission Type Pre-October 2009 

Procedures

 October 2009 

Procedures 

Total 

510(k) 17 2 19 

PMA 11 0 11 

IDE 5 0 5 

Humanitarian use 

device exemption 

0 1 1

 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 2008–2010 

Involved Parties Pre-October 2009 

Procedures

 October 2009 

Procedures 

Total 

Reviewers and 

managers 

21 2 23 

Peer reviewers 

within a single office 

9 9 0

Peer reviewers in 

two separate offices 

1 2 1

Unable to determine 2 0 2

 Total 33 3 36 

Source: OIG analysis of CDRH administrative files. 

The nature and resolutions of CDRH’s reported 

scientific disagreements varied widely 

CDRH’s 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. 

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Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470) 13 

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) 14 

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 submission’s 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 reviewer’s 

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) 

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 2008–2010 

Type of Documentation Number of Files 

Formal memorandum related to pre-October 2009 

procedures 

19 

Formal memorandum related to new procedures 

(post-October 2009) 

3 

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 CDRH’s 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). 

15 
 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470) 16 

 

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 

peers 

57 

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. 
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 CDRH’s 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 Public’s Health: 

The FDA 510(k) Clearance Process at 35 Years, 2011.
 45 21 CFR § 10.70(b)(2)(i).

46 CDRH’s 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 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470) 19 

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 CDRH’s 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 

2008–2010 period of our review. 
 

 

RECOMMENDATIONS 

Part of CDRH’s 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 device’s 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. 

CDRH’s regulatory decisions have significant implications for the public’s 

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 2008–2010 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 
Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470) 21 

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. 

FDA’s 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 

disagreements—whether formally resolved using the new procedures or 

informally resolved—are 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). 
 

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 

submission’s 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 FDA’s 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:---- rs -~-""""----

Attachment 

Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10·00470) 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 

HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and are 

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 

50 States and the District of Columbia, OI utilizes its resources by actively coordinating with the 

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 OIG’s internal 

operations. OCIG represents OIG in all civil and administrative fraud and abuse cases involving HHS 

programs, including False Claims Act, program exclusion, and civil monetary penalty cases. In 

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