Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
FDA   C M
S  LEARANCE OF  EDICAL 
 
D T 510( ) 
EVICES  HROUGH THE  K  
 
 
P  
ROCESS 
 
Daniel R. Levinson   
Inspector General  
 
September 2013 
OEI-04-10-00480   
   
EXECUTIVE SUMMARY:  FDAS CLEARANCE OF MEDICAL DEVICES 
THROUGH THE 510(k) PROCESS 
OEI-04-10-00480 
 
WHY WE DID THIS STUDY  
 
The Food and Drug Administrations (FDA) premarket notification (i.e., 510(k)) process 
is a faster and less stringent method to obtain clearance to market medical devices than 
the Premarket Approval (PMA) process.  FDA is required to classify devices by the level 
of control needed to provide reasonable assurance of device safety and effectiveness (i.e., 
Class I, II, or III). Most Class III devices must be approved through the PMA process, 
although some continue to be cleared through the 510(k) process using regulatory 
categories of devices (Class III preamendment device types).  The Safe Medical 
Devices Act of 1990 requires FDA to either reclassify Class III preamendment device 
types as Class II or I or keep them as Class III and require a PMA review.   
 
HOW WE DID THIS STUDY  
 
We determined whether FDA finished classifying the Class III preamendment device 
types used to clear devices through the 510(k) process, the number of Class III devices 
cleared using the 510(k) process, and the number of times each Class III preamendment 
device type was used to clear those devices through the 510(k) process from April 9, 
2009, to July 9, 2012. We reviewed documents in files submitted to us electronically by 
FDA for Class III and Class II devices cleared through the 510(k) process in 2010.  We  
did not determine whether FDAs clearance of the devices was appropriate. 
 
WHAT WE FOUND 
 
FDA has not finished classifying all types of Class III devices cleared through the 510(k) 
process, as required by Congress in 1990. As a result, FDA continues to clear some  
Class III devices through the 510(k) process.  Additionally, FDA did not consistently 
document the review of Class III and Class II devices cleared through the 510(k) process 
in 2010, according to our review of the files provided electronically by FDA.  Further, 
FDA did not provide complete administrative files during our data collection, thereby 
demonstrating deficiencies in its filing system.    
 
WHAT WE RECOMMEND 
 
FDA agreed with both of our recommendations to:  (1) in accordance with the law, finish 
classifying all types of Class III preamendment devices used to clear devices through the 
510(k) process and (2) improve its maintenance of administrative files for devices and 
continue to implement new policies on how to compile an administrative file.    
     
   
TABLE OF CONTENTS 
Objectives ....................................................................................................1 

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

Methodology................................................................................................9 

Findings......................................................................................................13 

FDA has not finished classifying all types of Class III 

preamendment devices, as required by Congress in 1990 .............13 

FDA did not consistently document the review of devices     
cleared through the 510(k) process in 2010 ...................................15 

Conclusion and Recommendations ............................................................17 

           Agency Comments and Office of Inspector General Response ......19 

Appendixes ................................................................................................20 

A: Documents That the Office of Inspector General Determined 

Should Reasonably Be Included in the Administrative Files for 

Devices Cleared Through the 510(k) Process ................................20 

B:  Type of Class III Preamendment Device, Number of         

Times Each Class III Preamendment Device Type Was Used To 
          
Clear 263 Unique Devices Through the 510(k) Process From 
            
April 9, 2009, Through July 9, 2012, and 515 Program 
       
Initiative Steps Completed as of July 9, 2012 ................................22 

C: Agency Comments  ...................................................................23 

Acknowledgments......................................................................................27 

 
     
   
OBJECTIVES 
1. 	  To determine whether the Food and Drug Administration (FDA) has 
finished classifying the remaining types of Class III preamendment 
devices that are currently used to review devices through the 
Premarket Notification (i.e., 510(k)) process.1  
2. 	  To determine whether FDA consistently documented the review of 
devices cleared through the 510(k) process in 2010.   
BACKGROUND 
The 510(k) process is a faster and less stringent method to obtain FDA 
clearance to market devices than the Premarket Approval (PMA) process.  
The Medical Device Amendments of 1976 (MDA) to the FFDCA 
established three regulatory classes for types of medical devices, on the 
basis of the level of control needed to ensure the safety and effectiveness 
of the device (i.e., Classes I, II, and III).2, 3   In recent years, there has been 
congressional and media interest in the 510(k) process, and consumer 
groups have criticized that process and FDAs use of it to review certain 
Class III devices.  
  Medical Device Approvals and Clearances 
A medical device is defined as an instrument, apparatus, implement...or 
other similar or related article, including any component, part, or 
accessory, which is...intended for use in the diagnosis of disease or other 
conditions, or in the cure, mitigation, treatment, or prevention of 
disease....4  Devices vary in complexity and application, ranging from  
simple tongue depressors to complex pacemakers.  FDAs Center for 
 
1 The 510(k) process is based on section 510(k)  of the Federal Food, Drug, and Cosmetic 
Act (FFDCA) (21 U.S.C.  360(k)).  The applicable regulations can  be found at 21 CFR 
Part  807, Subpart E.  
2 P.L. 94-295 (May 28, 1976). The device classes are described at section 513(a)(1) of the 
FFDCA (21 U.S.C.  360c(a)(1)). After the  enactment  of the MDA,  any new device 
(referred to as  a postamendment device) that is not substantially equivalent to a 
predicate device (a device already being legally marketed) is automatically classified as a  
Class III device.  The sponsor must either submit a PMA application or petition FDA to  
reclassify the device as Class I or II.  Section 513(f)(1)  (21 U.S.C.  360c(f)(1)). 
3 Devices are classified using types of devices in  21 CFR Parts 862-892.   
4 A medical device, as distinguished from a drug, does not achieve its  primary intended  
purposes  through  chemical  action within or on  the body of man or other  animals and  
which is not dependent upon being metabolized  for the achievement of its primary 
intended purposes.  Section 201(h) of  the FFDCA  (21 U.S.C.  321(h)).  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       1 
    
   
Devices and Radiological Health (CDRH) is, in part, responsible for the 
premarket review of devices.5    
The Premarket Approval process. The PMA review is the most stringent 
process for obtaining FDA approval to market a device and is required by 
statute for devices that support or sustain human life, are of substantial 
importance in preventing impairment of human health, or present a 
potential unreasonable risk of illness or injury. 6  For a device to receive 
approval via the PMA process, the device manufacturer (i.e., sponsor) 
must submit sufficient scientific evidence to demonstrate a reasonable 
assurance that it is safe and effective for its intended use.7   Typically, FDA  
requires sponsors to submit results of nonclinical laboratory studies and 
clinical investigations involving human subjects.8   
After a sponsor submits a PMA application, FDA performs a preliminary 
review to determine whether the application is sufficiently complete for 
scientists with subject matter expertise (reviewers) to begin a substantive 
review.9  FDAs substantive review includes inspections of manufacturing 
facilities, audits of clinical study data, and reviews of safety and 
effectiveness data and patient labeling information.10  
The Premarket Notification process. The 510(k) process is a faster and 
less stringent method for sponsors to obtain FDA clearance to market a 
device, and FDA is required by statute to review specific devices through 
the 510(k) process.  For a device to receive clearance via the 510(k) 
process, sponsors do not have to submit scientific evidence demonstrating 
that the device is safe and effective for its intended use, as is required 
under the PMA process.  Instead, sponsors must submit information 
demonstrating a devices substantial equivalence to a device already being 
legally marketed (i.e., the predicate device).11    
 
5 FDA encompasses seven centers.  CDRH  has primary responsibility for reviewing 
 
device submissions through the 510(k) process.  CDRH reviewed all devices cleared
  
through the 510(k) process in 2010.   

6 Sections 515(a) and 513(a)(1)(C)  of the FFDCA  (21 U.S.C.   360e(a) and  

360c(a)(1)(C)). 
 
7 Section 515(c) of the FFDCA (21 U.S.C.  360e(c)) and  21  CFR   814.20. 

8 21 CFR   814.20. 

9 21 CFR   814.42(a). 

10 FDA,  Premarket Approval:  PMA Review Process, June 8,  2011.  Accessed at 
 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour 

Device/PremarketSubmissions/PremarketApprovalPMA/ucm047991.htm on 
         
August 13, 2012.   

11 A legally marketed device to which a new device may be compared for a 
 
determination regarding substantial equivalence is a device that was legally marketed 
 
prior to May 28, 1976, or a device which has been  reclassified from class III to class II  or 
 
class I (the predicate), or a device which has been  found to  be substantially equivalent 
 
through the 510(k) premarket notification  process.  21 CFR   807.92(a)(3). 

FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       2 
    
   
FDA determines that a device is substantially equivalent to a predicate 
device if it has the same intended use  and technological characteristics as 
the predicate device.  FDA may also determine that a device is 
substantially equivalent to a predicate if it has the same intended use but 
different technological characteristics as the predicate and the information 
submitted to FDA does not raise questions of safety and effectiveness that 
are different from those raised by the predicate device.12, 13   
An FDA scientist with subject matter expertise analyzes data in the 
sponsors submissions to determine whether a device is substantially 
equivalent to its predicate device.  Once this reviewer reaches a final 
decision, CDRH managers (i.e., the Branch Chief and Division Director) 
review the file, including the reviewers final decision.  If the managers 
agree with the reviewers final decision, FDA sends a letter specifying the 
decision to the sponsor.  If the managers disagree with the reviewers final 
decision, CDRH may initiate its procedures for resolving scientific 
disputes.14, 15  Of all devices under review through the 510(k) process in 
2010, FDA cleared 71 percent (2,714 of 3,825) of them.16,  17    
Medical Devices, Types of Devices, and Regulatory 
Classification 
Medical devices are categorized into types that generally describe their 
function and characteristics.  The device type  determines for each what 
 
12 FDA,  Medical Devices:  Premarket Notification (510k). Accessed at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour 
Device/PremarketSubmissions/PremarketNotification510k/default.htm on August 28,  
2012.  A device cannot  be found substantially equivalent to the predicate device if the 
predicate device has been  removed  from the market at the initiative of FDA or  has been  
determined by  a judicial  order to  be misbranded or adulterated.  21 CFR   807.100(b).  
13 In December 2011, FDA issued new draft guidance on evaluating substantial 
equivalence.   FDA,  Draft Guidance for Industry and Food and Drug  Administration 
Staff, The 510(k) Program: Evaluating Substantial Equivalence in Premarket  
Notifications [510(k)] (12/27/2011).  This draft guidance was not in effect during our 
review.  
14 FDA,  FDA Staff  Manual  Guides, SMG 9010.1 Volume  IV, Agency Program  
Directives, General or Multidiscipline Dispute Resolution,  Scientific Dispute Resolution  
at FDA (eff. January  13, 2009); CDRH SOP for Resolution of  Internal Differences of  
Opinion in Regulatory Decision-Making  (September 4, 2012).   
15 CDRHs policies and procedures for addressing scientific  disputes were the subject  of  
another OIG evaluation, Scientific Disagreements Regarding Medical Device Regulatory 
Decisions, OEI-01-10-00470, June 2012. 
16 The remaining 29  percent  of devices were not cleared through the 510(k)  process.  For 
example, these  devices were determined to be not substantially  equivalent, had been  
withdrawn by the sponsor, or  had been exempted from premarket review.  2010 510(k)  
clearance data provided by  CDRH on August 25, 2011. 
17  When reporting the number  of individual devices cleared  by FDA through the 510(k)  
process, we included all 510(k) applications, including, for example, those that may have 
been submitted for clearance for changes to a device already being marketed  (i.e., a 
Special 510(k) review). 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       3 
    
   
the review process will be (e.g., PMA, 510(k)) or whether the device will 
be exempt from review.  Hereinafter, the term device is describes a 
unique device, and the terms type of device and device type describe a 
regulatory category of devices.18  
FDA classifies devices according to the level of control needed to provide 
reasonable assurance of the safety and effectiveness of the device (i.e., 
Classes I, II, and III).  Types of Class III devices include those that support 
or sustain human life, are of substantial importance in preventing 
impairment of human health, or present a potential unreasonable risk of 
illness or injury.19, 20  Generally, Class III devices must be approved via the 
PMA process.21   Table 1 contains the regulatory class, examples of types 
of devices in each class, and the premarket review process associated with 
each class.  
Table 1:  Medical Device Regulatory Classes, Examples of Types of Devices,  and 
Premarket Review Process  
Class  Examples of Types  Premarket Review Process 
of Device 
I  Tongue depressors,  Most are exempt from premarket review.*  Nonexempt devices must be 
stethoscopes  cleared through the 510(k) process rather than the PMA process. 
II  Syringes,   Some are exempt from premarket review.*  Nonexempt devices must be 
electrocardiographs  cleared through the 510(k) process rather than the PMA process. 
III  Implantable pacemakers,  In most cases, premarket approval is required.  In limited circumstances, 
atrial defibrillators  FDA clears Class III devices through the 510(k) process.  (FDAs clearance 
of Class III devices through the less stringent 510(k) process is discussed 
below.) 
     * Manufacturers of exempt devices must register and list the devices with FDA. 
 
Source:  OIG review of FDA Web site, Medical Devices:  Device  Classification.  Accessed at   
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm on April 27, 2012.  
 
 
 
18 Throughout this report, we state that FDA uses Class III preamendment device types 
to clear devices through the 510(k) process.  By this, we mean that a device within a 
Class III preamendment device type undergoes a 510(k)  review.    
19 Section 513(a)(1)(C) (21  U.S.C.  360c(a)(1)(C)).  Class I and Class II  devices are 
defined at sections 513(a)(1)(A) and (B) (21 U.S.C.  360c(a)(1)(A) and (B)), 
respectively. 
20 Devices with components from  more than one type of  device are classified at the higher 
class. FDA, Guidance for Industry and Food  and Drug Administration Staff - Medical  
Device Classification Product Codes (issued on  April 11, 2013).  Accessed at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument 
s/ucm285317.htm on July 25,  2013.  
21 There are exceptions, such as  devices that are substantially equivalent to a 
preamendment predicate device (21 CFR Part 814, Subpart A); devices that have an 
approved humanitarian device exemption (21 CFR Part 814, Subpart H); and  devices that  
have an approved investigational device exemption (21 CFR Part  812).  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       4 
    
   
Of the 2,714 devices that FDA cleared through the 510(k) process in 2010: 
   9 percent (241) were Class I, 
   89 percent (2,414) were Class II, and 
   2 percent (59) were Class III.  
Classification of Preamendment Medical Device Types 
Preamendment devices are those that were in commercial distribution 
before May 28, 1976, the date the MDA were signed into law.22   The MDA  
required FDA to classify all types of devices as one of the three 
established regulatory classes (i.e., Class I, II, or III) and to issue 
regulations requiring PMA review for all devices classified as Class III.23   
The MDA authorized FDA to convene classification panels to classify all 
the preamendment device types.24  The law required that FDA, once these 
device types were classified, take a number of steps for every Class III 
preamendment device type, including publishing a notice of proposed 
rulemaking; allowing comments on the proposed rule; providing an 
opportunity to request reclassification of the device type on the basis of 
new information; initiating a proceeding to reclassify the device type; and 
then, if the device type was determined to be Class III, publishing a final 
regulation requiring submission of a PMA application.25    
By the late 1980s, FDA had not finished classifying all Class III 
preamendment device types.26  Until FDA finishes classifying (i.e, 
reclassifying as Class I or Class II or requiring a PMA review) these Class 
III preamendment device types, all devices that relied on predicate devices 
in Class III preamendment device types are required to be reviewed 
through the 510(k) process.27      
In the Safe Medical Devices Act of 1990, Congress mandated that FDA  
before December 1, 1995: (1) require all manufacturers of preamendment  
 
22 FDA uses the term preamendment device to describe devices marketed before      
May 28, 1976, and devices substantially equivalent to them that have been  marketed 
since May 28, 1976.  See, e.g., 59  Fed. Reg.  23731 (May 6, 1994). 
23 Section 2 of  P.L. 94-295, adding  sections 513 and 515  of the FFDCA  (21 U.S.C.        
 360c and 360e). 

24 FDA,  PMA Historical Background. Accessed at 
 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour 

Device/PremarketSubmissions/PremarketApprovalPMA/ucm046769.htm on August 28, 
 
2012.  

25  Section 2 of P.L. 94-295, adding section 515(b) of  the FFDCA  (21 U.S.C.  360e(b)).   

26  Government Accountability Office (GAO) (09-190), p. 11, FDA Should Take Steps to 

Ensure that  High-Risk Device Types are Approved through the Most Stringent  Premarket 
 
Review Process.  Issued January 2009.  Accessed at 

http://www.gao.gov/new.items/d09190.pdf on January 4,  2011. 

27 Section 513(f)(1)(A) of the FFDCA (21 U.S.C.  360c(f)(1)(A)); 21 CFR  
                   
 807.92(a)(3).  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       5 
    
   
devices that were classified as Class III with no PMA requirement to 
submit a summary of information to FDA, including adverse safety or 
effectiveness information, and (2) reexamine the remaining types of Class 
III preamendment devices to determine whether they should be 
reclassified as Class I or II or remain as Class III.  If device types 
remained as Class III, FDA was required to establish, within 12 months, a 
schedule for the Class III devices to undergo PMA review.28, 29  
A May 1994 Federal Register notice described FDAs plan for 
implementing the Safe Medical Devices Act of 1990.30  FDA planned to 
propose regulations to finish classifying all the remaining types of Class 
III preamendment devices.  As of 1994, FDA had not finished classifying  
117 Class III preamendment device types.31  Between 1994 and 2009, 
FDA finished classifying 91 of these types.32  However, as of 2009, FDA  
had not finished classifying the remaining 26 types.  On April 9, 2009, 
FDA issued a Federal Register notice requiring sponsors to submit 
additional safety information to FDA by August 7, 2009, for 25 types of 
Class III preamendment devices.33  One additional type of Class III 
preamendment device was addressed separately in the Federal Register.34   
On April 9, 2009, FDA began the 515 Program Initiative to finish 
classifying the 26 remaining types of Class III preamendment devices.35,  36   
 
28 Section 4 of  P.L. 101-629 (November, 28, 1990), adding section  515(i)  of  the FFDCA 
(21 U.S.C.  360e(i)).   
29 FDA,  PMA Approvals. Accessed at 
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandcl 
earances/pmaapprovals/default.htm on  August 28, 2012.  Sponsors of Class III  
preamendment devices are not required to submit PMA applications until 30 months after 
the promulgation of a final classification  regulation  or until 90  days after the publication 
of a final regulation requiring the submission  of PMA applications, whichever period is  
later. FDA may allow more than 90  days after the promulgation  of a final rule for 
submission of  a PMA application.  See section 501(f)(2)(B) of the FFDCA (21 U.S.C.      
 351(f)(2)(B)).    
30 59 Fed. Reg. 23731  (May 6,  1994). 

31 GAO (09-190), p. 43, FDA Should Take Steps to Ensure that High-Risk Device Types  

are Approved through the Most Stringent Premarket Review Process.  Issued January 

2009. Accessed at http://www.gao.gov/new.items/d09190.pdf on January 4, 2011. 

32  FDA,  515 Program Initiative. Accessed at 
 
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CD 

RH/CDRHTransparency/ucm240310.htm  on  August 28, 2012.  

33  74  Fed.  Reg. 16214 (April 9, 2009). 

34 76 Fed. Reg. 22805   (April 25, 2011). 

35 FDA, 515 Program Initiative.  Accessed at 

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CD 

RH/CDRHTransparency/ucm240310.htm  on  January 11, 2011.  This guidance has been 
 
revised by FDA to reflect changes made by the Food and Drug Administration Safety and
  
Innovation Act  (FDASIA), discussed below. 
 
36 The 515 Program Initiative is based  on section 515 of  the FFDCA (21 U.S.C.  360e), 

which requires  Class III devices to undergo PMA review  to be legally  marketed.   

FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       6 
    
   
For types of devices that will remain Class III, FDA will call for PMA  
applications for all devices within the device type.   
The 515 Program Initiative had five steps.   
	   Step 1: FDA collects existing scientific information (e.g., safety of 
the devices) in the public domain and/or from scientific experts in 
the medical community. 
	   Step 2: FDA assesses the risks and benefits of the types of devices, 
as well as the clarity of knowledge of the medical device type 
subject to the reclassification.  
	   Step 3: FDA issues a proposed rule to classify the type of device 
into Class I, II, or III.  
	   Step 4: FDA receives and reviews comments submitted by the 
public regarding the proposed classification.  
	   Step 5: FDA issues a final rule, which notifies the public and 
stakeholders of the classification of the type of device as either 
Class I, II, or III.   
Once FDA requires PMA review for devices within a Class III 
preamendment device type, all sponsors of those previously cleared 
devices, as well as sponsors of those devices determined to be 
substantially equivalent to a preamendment device in that type, must 
submit PMA applications.  For each of these devices, FDA must approve 
the PMA application for the sponsor to continue marketing the device; 
however, if the application is filed in a timely manner, the device may 
continue to be marketed while the application is under review.37  Each 
device type may include hundreds of unique devices, each of which would 
be subject to a PMA review.  For example, in the pedicle screw spinal 
system device type, which is one of the remaining 26 Class III 
preamendment device types, FDA cleared 157 individual Class III devices 
between April 9, 2009, and July 9, 2012.    
On July 9, 2012, FDASIA established a new process for finishing the 
classification of types of Class III preamendment devices.38 Before a Class 
III preamendment device type can have a finished classification, FDA will  
now be required to issue an administrative order following publication of a 
proposed order, convene a device classification panel meeting, and 
consider public comments.  The statute specifies that the new process 
applies to reclassifying or requiring PMA review for types of Class III 
 
37 Sections  515(b)(1) and 501(f)  of the FFDCA (21 U.S.C.    360e(b)(1) and 351(f)).  
38  P.L. 112-144, section 608(b),  amending section 515(b)  of the FFDCA  (21 U.S.C.         
 360e(b)).  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       7 
    
   
preamendment devices, except those for which final rules had been 
promulgated before the date of enactment, July 9, 2012.  FDASIA amends 
the timeframe for FDA to finish classifying all types of Class III 
preamendment devices to July 9, 2014, which is 2 years from the date of 
FDASIAs enactment.39    
FDAs Documentation of Medical Device Clearance 
FDA creates an administrative file for each PMA or 510(k) application 
submitted by a sponsor, which includes all documents pertaining to a 
particular administrative action, including internal working memoranda, 
and recommendations.40  Further, FDA must include certain 
documentation in the administrative file for every significant FDA  
decision on any matter under the laws administered by the [FDA] 
Commissioner.41  Federal regulations state that documentation of the 
significant decision includes [a]ppropriate documentation of the basis for 
the decision, including relevant evaluations, reviews, memoranda, letters, 
opinions of consultants, minutes of meetings, and other pertinent written 
documents; and [t]he recommendations and decisions of individual 
employees, including supervisory personnel, responsible for handling the 
matter.42  Further, Federal regulations state that documents that are 
prepared by agency employees but are not in the administrative file have 
no status or effect for the purpose of approving or clearing a device.43   
The fact that documents are missing does not necessarily indicate that a 
device was improperly approved or cleared.  Finally, Federal regulations 
require that all written documents in the administrative file be signed and 
dated by the author.44    
FDA issued several relevant Standard Operating Procedures (SOPs) 
during or after our review. On July 19, 2010, FDA issued an SOP entitled 
Documentation of Meetings with Sponsors and Applicants.4 5  On July 1, 
2011, FDA issued Documentation of Informal Conversations and 
Communications Regarding Premarket Submissions.46  As of January 
2012, when we completed data collection for our file review, FDA had not 
defined, beyond the requirements of 21 CFR  10.70 and these SOPs, the 
 
39  P.L. 112-144, section 608(b)(1)(C), amending  section  515(i)(2) of the FFDCA    
       
(21 U.S.C.     360e(i)(2)). 
 
40 21 CFR   10.3(a). 

41 21 CFR   10.70(a) and (b).   

42 21 CFR   10.70(b).   

43 21 CFR   10.70(d).   

44 21  CFR  10.70(c)(2). 
 
45  CDRH  ODE/OIVD SOP 2010-001: Documentation of  Meetings with Sponsors and  
Applicants, Version 1,  (effective July 19, 2010). 

46  CDRH  ODE/OIVD SOP 2011-001:  Documentation  of Informal  Conversations and 

Communications  Regarding Premarket Submissions, Version  1, (effective July 1, 2011). 
 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       8 
    
   
specific documents that must be in administrative files.  On September 20, 
2012, FDA implemented the SOP entitled Compiling the Administrative 
File for Premarket Submission Decisions.4 7  The stated purpose of this 
SOP is to establish written procedures for creating the Administrative 
File for premarket submission decisions by CDRH review staff.  This 
SOP was not in place during our review period and was not considered in  
developing our methodology. 
According to FDA officials, the administrative files supporting premarket 
submission decisions for medical devices, including files for devices 
undergoing 510(k) reviews, generally are compiled by the reviewer in 
paper format and then uploaded into the agencys electronic filing system, 
known as IMAGE. The paper documents may be housed in binders until 
they are transferred to IMAGE.  Once the paper documents are uploaded 
to IMAGE, they are retained until the paper file is validated against the 
electronic file and FDA confirms  that IMAGE contains the full 
administrative file.  According to FDA, until this validation is complete, 
CDRH staff can access the paper files, upon request.  
Related Work  
In 2009, GAO issued a report on FDAs PMA and 510(k) review 
processes.48  GAO analyzed data on PMA and 510(k) submissions for 
fiscal years 2003 through 2007 and analyzed the extent to which FDA  
used the 510(k) process to clear Class III devices.  GAO recommended 
that FDA reclassify each remaining Class III device type as Class I or 
Class II or require that it remain in Class III and, for those device types 
remaining in Class III, require approval for marketing through the PMA  
process. The Department of Health and Human Services concurred with 
GAOs recommendations.   
METHODOLOGY 
Scope 
We determined whether FDA finished classifying the remaining types of 
Class III preamendment devices, determined the number of Class III 
devices cleared through the 510(k) process, and determined the number of 
times Class III preamendment device types were used to clear these 
devices from  April 9, 2009, until July 9, 2012. We also determined 
whether documents that we concluded should reasonably be included in 
 
47  CDRH SOP CDRHOCD012: Compiling the Administrative File for Premarket 
Submission Decisions, Version 1.0, (effective September 20, 2012). 

48 GAO (09-190), FDA  Should Take Steps to Ensure that High-Risk Device  Types are 

Approved through the Most  Stringent Premarket Review Process.  Issued January 2009. 
  
Accessed at http://www.gao.gov/new.items/d09190.pdf on  January 4, 2011. 
 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       9 
    
   
the administrative file to clear Class III and II devices through the 510(k) 
process in 2010 were present. In October and November 2011, we 
requested that FDA provide us the complete administrative files for 163 
devices cleared through the 510(k) process in 2010.  FDA provided files to 
us electronically within 30 days of our request and said that the electronic 
transmission completely fulfilled our data request.  
We did not determine whether FDAs decisions in 2010 to clear devices 
through the 510(k) process were appropriate.   
Data Collection and Analysis 
Determining whether FDA finished classifying the 26 remaining types of  
Class III preamendment devices, determining the number of Class III 
devices cleared through the 510(k) process, and determining the number 
of times Class III preamendment device types were used to clear these 
devices from April 9, 2009, to July 9, 2012. We analyzed relevant statutes, 
regulations, Federal Register notices, and CDRH responses to survey 
questions. On the basis of these documents, we determined the status of 
the 26 types of Class III preamendment devices in FDAs 515 Program  
Initiative. 
We obtained the three-digit product codes identified in FDAs 515 
Program Initiative Project Status table.49  Then, we searched FDAs 510(k) 
clearance database using these product codes to determine the number of 
times that Class III preamendment device types were used to clear devices 
between April 9, 2009, the date FDAs 515 Program Initiative began, and 
July 9, 2012, when FDASIA was enacted.50   We then determined the 
number of devices that were cleared using these Class III preamendment 
device types.   
Determining the extent to which FDA administrative files included 
documents to clear Class III and Class II devices through the 510(k)  
process in 2010. During our review period, FDA had not defined the 
specific documents that must be in administrative files; therefore, we 
based our assessment of what documents we determined should 
reasonably be included in an administrative file on our review of relevant 
Federal regulations, preinspection reviews of 510(k) administrative files, 
and meetings with FDA officials.  See Appendix A for the 12 types of 
documents that we determined should reasonably be included in an 
administrative file.    
 
49 FDAs 515  Program Initiative Project Status table is at 
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CD 
RH/CDRHTransparency/ucm240318.htm.  Accessed  on July 25, 2013.   
50 FDAs online  510(k) clearance database is at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       10 
    
   
We reviewed each electronic file to determine which documents were 
present.  We examined each page of all documents in the file. We also 
reviewed the files to see whether all written documents were signed and 
dated. We considered all emails included in the files to be signed and 
dated. We did not determine whether documents submitted by the sponsor 
were signed and dated.51    
We did not determine which of these documents constitute [a]ppropriate 
documentation of the basis for the decision, including relevant 
evaluations, reviews, memoranda, letters, opinions of consultants, minutes 
of meetings, and other pertinent written documents as stated in 21 CFR  
10.70. Rather, we considered all documentation that we found in the files 
or found referenced in the files to be relevant and pertinent.   
We selected a stratified random sample of 163 devices cleared through the 
510(k) process in 2010. We reviewed files for 159 of the devices.52   The 
sample consisted of all 59 Class III devices and a sample of 100 of the 
2,414 Class II devices. Table 2 shows the number of population and 
sample devices by stratum.  
 
Table 2:  Number of Population and Sample Devices by Stratum 
Number of Devices 
Cleared Through the  Sample 
Stratum  510(k) Process in 2010  Size 
Class II Devices  2,414  100 
Class III Devices  59  59 
Class II and Class III Devices  2,473  159 
Source: OIG Analysis of FDA 510(k) database, 2011. 
 
Limitations 
We may not have identified all documents missing from the administrative 
files that were relevant and pertinent to the 510(k) review.  For example, if 
FDA held a meeting with the sponsor and there was no reference to the 
meeting in the administrative file, we would not be aware that the meeting 
occurred and, therefore, did not report the meeting minutes as missing. 
 
51  We interpreted the requirements at 21  CFR  10.70(c) to apply  only to records 
generated by  FDA.  
52 FDA provided a list of all devices cleared through the 510(k)  process in  2010.  We  
requested a sample of 163 files from this list.  However, during the file review, we 
discovered that one of the devices was a Class I device (i.e., not within  the scope of our  
study).   Also, three devices on FDAs list classified as Class III were actually Class II 
devices.  We decided to exclude these four devices from the sample; therefore, we 
reviewed a total of 159 files. 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       11 
    
   
Further, to the extent that we did not receive all relevant documents, the 
omission may have affected our conclusions as to the consistency and 
completeness of documents maintained in the 510(k) administrative files.   
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. 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       12 
    
   
FINDINGS 
FDA has not finished classifying all types of Class III 
preamendment devices, as required by Congress in 
1990    
When the Safe Medical Devices Act of 1990 was enacted, FDA was 
required to finish classifying the 117 types of Class III preamendment 
devices. Between 1994 and 2009, FDA reclassified types of devices as 
lower classes or retained the Class III classification, thus requiring a PMA  
review for each device within the device type, for 91 of these device types.  
From  April 9, 2009, when the 515 Program Initiative began, until July 9, 
2012, when FDASIA amended the process and extended FDAs deadline, 
FDA finished classifying 7 of the remaining 26 types of Class III 
preamendment devices.  During this period, FDA cleared 260 Class III 
devices through the 510(k) process using 12 of the remaining 19 types of 
devices.  
As of July 9, 2012, FDA had not finished classifying 19 types of 
Class III preamendment devices  
From  April 9, 2009, when the 515 Program Initiative began, until July 9, 
2012, when FDASIA was enacted, FDA  collected existing scientific 
information (e.g., information on the safety of the devices) in the public 
domain and/or from scientific experts in the medical community for all of  
the remaining 26 types of Class III preamendment devices.  This was the 
first step of FDAs five-step 515 Program Initiative.  During this time, 
FDA also assessed the risks and benefits of each of the remaining 26 types 
of preamendment devices, completing step 2 of the 515 Program Initiative.  
FDA issued rules proposing classification for 13 device types and had 
received and reviewed comments for 11 device types, completing steps 3 
and 4 of the 515 Program Initiative.   As of July 9, 2012, FDA issued a rule 
finishing the classifications for seven types of devices.   
Of these seven types of Class III preamendment devices, six remained 
Class III devices and all devices in that type will now be required to 
undergo PMA review.  The remaining type of Class III preamendment 
device was reclassified as Class II.  As a result, new devices within this 
type can continue to be cleared through the 510(k) process. 
Table 3 shows the step in the 515 Program Initiative that was completed 
and the number of types of devices in each step from  April 9, 2009, until  
July 9, 2012. 
   
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       13 
    
   
 
Table 3:  Completed Steps in the FDA 515 Program Initiative and 
Number of Types of Devices per Step, April 9, 2009  July 9, 2012 
Number of Types of 
FDA 515 Program Step Completed   Devices 
Step 1  Collect existing scientific data  26 
Step 2  Assess device risk and benefits  26 
Step 3  Issue proposed rule   13 
Step 4  Receive and review public comments   11 
Step 5  Issue final rule  7 
Source: OIG analysis of FDA 515 Program Initiative status, 2013. 
  
See Appendix B for the type of device, number of times Class III 
preamendment device types were used to clear Class III devices from  
April 9, 2009 to July 9, 2012, and 515 Program Initiative steps completed 
as of July 9, 2012. 
FDA staff cited barriers to issuing proposed and final rules as the reason 
for the 21-year delay in finishing classifying all preamendment device 
types. For example, under the 515 Program Initiative, FDA cited the time  
to convene classification panels, the  time to complete the rulemaking 
process, and disagreement on the part of  industry and advocates about the 
best classification for these types of Class III preamendment devices. FDA  
informed us that as of February 17, 2012, it expected to recommend that at 
least 10 of the 22 remaining types of Class III preamendment devices 
remain Class III.   
On July 9, 2012, FDASIA established a new process for reclassifying 
devices. Before types of Class III preamendment devices can have a 
finished classification, FDA is now required to issue an administrative 
order following publication of a proposed order, convene a device 
classification panel meeting, and consider public comments.   The statute 
specifies that the new process applies to reclassifying or requiring a PMA  
review for types of Class III preamendment devices, except those for 
which final rules had been promulgated before the date of enactment, July 
9, 2012. The long-term effect of this process change has yet to be 
determined, but FDA has informed us that implementing it has further 
delayed progress. 
From April 9, 2009, to July 9, 2012, FDA cleared 263 Class III 
devices through the 510(k) process 
From  April 9, 2009, to July 9, 2012, FDA cleared 263 devices through the 
510(k) process that were determined to be substantially equivalent to Class 
III preamendment devices in the 515 Program Initiative.  Of those devices,  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       14 
    
   
FDA cleared 260 devices using 12 types of Class III preamendment 
devices that have not completed the 515 Program Initiative.53    
Three devices were cleared using one type of device that has completed 
the 515 Program Initiative.54  Devices within the remaining 13 types of 
devices were not used as predicates to clear any new devices through the 
510(k) process from April 9, 2009, to July 9, 2012.  Twenty-one of the 
devices cleared through the 510(k) process during our review period used 
more than one Class III preamendment device type.  Thus, Class III 
preamendment device types were used 284 times to clear 263 individual 
devices during our review period. See Appendix B for the 26 types of 
Class III preamendment devices in the 515 Program Initiative, the number 
of times each device type was used to clear each of the individual 263 
devices from  April 9, 2009, to July 9, 2012, and the 515 Program Initiative 
steps completed for each type of device. 
  
FDA did not consistently document the review of 
devices cleared through the 510(k) process in 2010 
Most of the files for Class III and Class II devices cleared through the 
510(k) process in 2010 contained most of the documents that we 
concluded should reasonably be included in the administrative files.  
However, most of the electronic files we reviewed were missing at least 
one document.  Missing documents included reviewers notes, 
memorandums describing the basis for FDAs clearance, and minutes of 
meetings between FDA reviewers and device sponsors.  Further, many 
documents in the files were not signed and dated. 
After we finished our review of FDAs files and during FDAs review of a 
preliminary draft of the report, FDA informed us that not all documents 
had been loaded into IMAGE at the time we requested our data.  
Therefore, FDA had not provided us with the complete administrative files 
we requested. FDA explained that we had been given documents in the 
electronic files but not paper documents and that some  of the electronic 
files we received had not been validated as complete.  To the extent that 
not all relevant documents were provided to us, the omission may have 
affected our conclusions as to the consistency and completeness of 
documents maintained in the 510(k) administrative files.  Our review of 
 
53  For 9 of  these 12  types of  devices, FDA had completed Step 2 of  the five-step 515 
Program  Initiative.  For 3 of  these 12  types of devices, FDA had completed Step  3  of the 
515  Program Initiative.   
54 After the clearance of these three devices, FDA reclassified the type of device as Class 
II, so all devices in this type  will continue to  be cleared through the 510(k) process; this 
explains why only 260 of the 263 Class III  devices were cleared using Class III  
preamendment device types that FDA has still not finished  classifying.  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       15 
    
   
files FDA submitted electronically and FDAs initial indication that it had 
provided complete information to us did not alert us to the fact that 
additional paper records may have existed. 
Our review of the electronic files showed that FDA did not consistently 
document the review of devices cleared through the 510(k) process in 
2010. As FDA recently stated, [C]omprehensive and accurate 
documentation of the deliberative process is essential to subsequent 
reviewers and supervisors that assume responsibility for the premarket 
review. Such documentation also ensures that a rational basis exists for 
agency decisions and promotes transparency and accountability in 
decision-making.55  FDA also noted the need for procedures to enable 
CDRH review staff and managers to appropriately and systematically 
document the facts, data, science, and deliberative process concerning 
premarket decisions.56  Our review also revealed vulnerabilities in FDAs 
management of its administrative files.  An adequate process for 
maintaining administrative files requires transparency regarding the 
location of documents and the completeness of the files.  The lack of such 
a process could lead to confusion and human error.   
 
 
 
 
 
   
 
55  CDRH SOP CDRHOCD012: Compiling the Administrative File for Premarket 

Submission Decisions, Version 1.0, (effective September 20, 2012). 

56 Ibid. 

FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       16 
    
   
CONCLUSION AND RECOMMENDATIONS 
The 510(k) process is a faster and less-stringent method to obtain FDA  
clearance to market a medical device than the PMA process.  For example, 
in the 510(k) process, sponsors must show that a device is substantially 
equivalent to a predicate device. The PMA process requires that sponsors 
demonstrate a reasonable assurance of safety and effectiveness for a 
devices intended use through the submission of sufficient scientific 
evidence. Predicate devices used to establish substantial equivalence in 
the 510(k) process include Class III preamendment devices.  For these 
Class III preamendment device types, FDA must either reclassify them as 
a lower class or require that they remain Class III and call for a PMA  
review.  In recent years, the media and consumer groups have criticized 
FDAs continued use of the 510(k) process to clear Class III devices.  
FDA has not finished classifying all types of Class III preamendment 
devices, as required by Congress in 1990 and as currently required by 
FDASIA.  As a result, Class III devices continue to be cleared through the 
510(k) process.  Although FDA has not finished classifying these Class III 
preamendment device types, some of them may be reclassified as Class II, 
and devices can continue to be cleared through the 510(k) process with no 
change to the review process. For example, one of the seven device types 
that FDA finished classifying during the 515 Program Initiative was 
reclassified as Class II. However,  FDA determined that six of the seven 
device types will remain Class III device types, and all previously cleared 
and new devices in that type will undergo PMA review and be required to  
demonstrate a reasonable assurance of safety and effectiveness.   
With the enactment of FDASIA  in 2012, Congress repeated its 1990 
directive to finish classifying all Class III preamendment device types but 
changed the classification process by which these device types must be 
reviewed. FDA should finish classifying all Class III preamendment 
device types as quickly as possible and no later than July 9, 2014, 
consistent with FDASIA.  This will promote public health by requiring 
devices already on the market in those Class III device types to receive the 
more stringent PMA review to reasonably ensure they are safe and 
effective for their intended use.   
Additionally, we found that FDA did not consistently document the review 
of devices cleared through the 510(k) process in 2010, according to our 
review of the files provided electronically by FDA.  Further, FDA did not 
provide complete administrative files during our data collection, thereby 
demonstrating deficiencies in its filing system.  We recommend that FDA: 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       17 
    
   
In accordance with the law, finish classifying the remaining 19 
types of Class III preamendment devices that include devices 
still used as predicates in the 510(k) process  
Starting with the highest risk device types, which include devices that are 
used most frequently as predicates to clear Class III devices, FDA should 
complete the classification process for all types of Class III preamendment 
devices as soon as possible but no later than July 9, 2014, the deadline 
established in FDASIA. 
Improve its maintenance of administrative files for devices and 
continue to implement new policies on how to compile an 
administrative file 
FDA should examine its maintenance of administrative files for all cleared 
devices. FDA should keep all paper documents in a central location and 
scan them expeditiously to the electronic file. The FDA administrative file 
should be maintained such that anyone legitimately consulting the file 
even those outside CDRHcan easily ascertain whether the file is 
complete or additional documents exist elsewhere. 
FDA should also continue to implement its new SOP on how to compile 
the administrative file for decisions on 510(k) device submissions.  This 
policy could include standard review templates.  FDA should also require 
reviewer training that describes how to document the 510(k) 
administrative files.  
 
 
 
 
 
 
 
 
 
 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       18 
    
   
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
In its comments on the draft report, FDA agreed with both of our 
recommendations.  FDA agreed with the first recommendation to, in 
accordance with the law, finish classifying the remaining 19 types of Class 
III preamendment devices that include devices still used as predicates in 
the 510(k) process. FDA stated that it is taking steps to modify its 
procedure to comply with the new law.  Further, FDA indicated it has 
made significant progress toward completing the classification of the 
remaining types of Class III preamendment devices.  For example, for 69 
percent of the Class III preamendment device types that remained when 
the 515 Program Initiative began in 2009, FDA indicated that it has issued  
proposed orders or finished classifying the device types through the 
rulemaking process as of June 1, 2013.   
FDA also agreed with the second recommendation to improve its 
maintenance of administrative files for devices and continue to implement 
new policies on how to compile an administrative file.  FDA indicated it 
has significantly improved its policies on how to compile an 
administrative file.  For example, CDRH finalized and implemented an 
SOP to establish written procedures for creating the administrative file.  
FDA has also implemented technological changes that have facilitated the 
introduction of a standard review template. 
FDA questioned the relevance of our finding that FDA did not consistently 
document the review of devices cleared through the 510(k) process in 
2010, according to our review of the electronic files provided to us.  FDA  
believes that we included in our review some documents that are not 
required by regulation or SOP to be in the administrative file and cites two 
documents specifically.  On the basis of our inclusion of these particular 
documents, FDA questions the relevance of our finding.  At the time of 
our review, we did not have the benefit of FDAs SOP (which had not yet 
been issued). FDA did not specifically require these two documents, or 
any other particular documents, to be in the administrative file. Further,  
most of the files in our review did contain the two specific documents that 
FDA cited.  Therefore, the inclusion of these two documents, in particular, 
had minimal effect on our findings.   
FDA also provided technical comments.  In response, we made revisions 
to the report, where appropriate. For the full text of FDAs comments, see 
Appendix C. 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       19 
    
     
APPENDIX A 
Documents That the Office of Inspector General Determined 
Should Reasonably Be Included in the  Administrative Files for 
Devices Cleared Through the 510(k) Process   
 
On the basis of our review of relevant statutes and regulations, our 
preinspection review of 10 administrative files, and input from Food and 
Drug Administration officials during preinspection, we identified 
documents that we determined reasonably should be included in the file to 
clear the device through the 510(k) process. We grouped the documents 
in this manner on the basis of the organization of administrative files and 
for the purposes of reporting our results.  FDA does not formally group the 
documents in this manner.57     
 
A.   Documentation of the reviewers analysis: 
  
1. 	  Reviewer Cover Sheet, 
2. 	  Reviewer Memorandum, and 
3. 	  Reviewer Decision Flowchart.58, 59  
B.   All minutes of meetings and correspondence with sponsors and 
records of consultations with FDA staff:  
4. 	  the contents of all phone calls, emails, or other meetings between 
FDA reviewers and the sponsor; and 
 
 
 
 
 
57 The focus of this review is documents that support  the  analysis  of FDA reviewers.   
Supervisor decisions and recommendations, as referenced  in 21  CFR  10.70(b)(2), may  
be  included  in group 1 or 2, depending on whether they are contained in written Reviewer 
Memorandums or if they were expressed in  meetings or correspondence.  The FDAs  
official Clearance Letter is included in group 3.  
58 The Reviewer  Cover Sheet documents the reviewers analysis of the device through the 
510(k)  process.  The Reviewer Memorandum contains the reviewers final summary of 
the deficiencies identified, additional information submitted  by the sponsor to address the 
deficiencies, and the reviewers conclusion about whether the additional information  
addresses the deficiencies.  The Reviewer  Decision Flowchart documents the logic used  
to clear the device through the 510(k)  process.  
59  At  the  time  of our review, FDA did not  specifically require the Reviewer Decision 
Flowchart, the  Medical Device User Fee Form, or any  other documents to  be in the 
administrative file.  However, most of the files in  our review did contain the Reviewer  
Decision Flowchart and the  Medical Device User Fee Form.     
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       20 
    
     
5. 	  the contents of all internal FDA  discussions or consultations, or 
emails regarding device clearance.60, 61  
C.   Other standard documents pertinent to the decision to clear the device: 
6. 	  letter from FDA to the sponsor clearing the device through the 
510(k) process (i.e., the FDA Clearance Letter); 
7. 	  letter from FDA to the sponsor acknowledging that FDA received 
the original 510(k) submission (i.e., the FDA  Acknowledgement 
Letter);  
8. 	  letter(s) from FDA to the sponsor confirming FDAs receipt of 
additional information the sponsor submitted (i.e.,  Additional 
Information Confirmation letter); 
9. 	  Medical Device User Fee Form;62   
10.  additional information submitted by the sponsor in response to the 
reviewers request;  
11.  the original 510(k) submission from the sponsor; and 
12.  the 510(k) Summary.63  
 
60 We  manually reviewed each administrative file to determine whether all minutes of 
meetings and correspondence  with sponsors and records of consultations  with FDA staff 
were present.  If documents in the administrative file contained a sufficient level of detail, 
attendees,  and dates of meetings, we considered these to  be minutes and records.    
61 Opinions of consultants, as referenced in   21 CFR   10.70, may be included in group 1 
or 2, depending  on whether they are contained in written Reviewer Memorandums or  
whether they  were expressed in meetings or correspondence. 
62 The Medical Device User Fee Form documents that the sponsor paid the user  fee, if 
required, to FDA for the 510(k) submission.  
  
63 The 510(k) Summary provides basic information about the device and the sponsor.
   
The 510(k) Summary  is posted on  FDAs public Web site after a device is cleared.  

FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       21 
    
     
APPENDIX B 

Type of Class III Preamendment Device, Number of Times Each  Class III Preamendment Device  Type  Was Used To Clear 263 Unique Devices 
Through the  510(k)  Process From April 9,  2009,  Through July 9,  2012,  and 515 Program Initiative  Steps Completed as of  July 9, 2012 
Times Device Type 
Used to Clear 
Devices through the  Step 1  Step 2  Step 3  Step 4  Step 5 
Type of Class III Device   510(k) Process  Complete   Complete   Complete   Complete   Complete  
Pedicle screw spinal system   157            
Hip  joint metal/metal semiconstrained, with an  
uncemented acetabular component, prosthesis   27             
Automated external defibrillator  24             
Implanted blood access device   20          
Hip  joint metal/metal semiconstrained, with cemented  
acetabular component, prosthesis  16            
Nonroller-type cardiopulmonary bypass blood pump   15             
External cardiac compressor  10            
Intra-aortic balloon and control system  4            
Shortwave diathermy  3           
Iontophoresis device  3            
External counter-pulsating device  1             
Cranial electrotherapy stimulator  1        
Electroconvulsive therapy device  0            
Endosseous dental implant (blade-form dental implants)   0             
Membrane lung  for long-term pulmonary support (i.e.,  
ECMO)  0            
Mandibular condyle  prosthesis   0             
Transilluminator for breast evaluation  0        
External  pacemaker pulse generator   0         
Sorbent hemoperfusion system   0         
Topical oxygen  3      
Female condom  0      
Implantable pacemaker pulse generator   0       
Pacemaker programmers  0      
Pacemaker repair or replacement material  0      
Cardiovascular permanent pacemaker electrode   0       
Ventricular bypass device  0       
TOTAL   284*  26  26   13  11  7 
Source: OIG analysis of FDA 515 Program Initiative  status and FDA 510(k) online clearance database, 2013. 

 Class III preamendment device types were used 284 times to clear 263 individual devices from April 9,  2009, through July 9, 2012  
  
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)        22    APPENDIXC 
Agency Comments 
.;;""'"'""'"' 
f 
_#DEPARTMENT OF HEALTH AND HUMAN SERVICES 
\.:~~ 
Food and Drug Administration 
S1lver Spring MD 209 93 
Date:  June 21,2013 
To:  Inspector General 
From:  Acting Associate Commissioner for Policy and Planning 
Subject:  FDA's General Comment to OIG Dmft Report on FDA's Clearance of Medical 
Devices Through the 51 O(k) Process 
FDA is providing the attached general comments to the Office oflnspector General's draft report 
entitled, FDA 's Clearance ofMedical Devicp Through the 51 O(k) Process (OEI-04-1 Oc00480). 
FDA appreciates the opportunity to review and comment on this draft report before it is 
published . 
Peter Lurie, MlY,tiPH 
Attachment 
FDA's Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)  23   
     
 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       24 
    
     
 
 
 
   
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       25 
    
     
 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       26 
        
     
ACKNOWLEDGMENTS 
This report was prepared under the direction of Dwayne Grant, Regional 
Inspector General for Evaluation and Inspections in the Atlanta regional 
office, and Jaime Durley, Deputy Regional Inspector General.   
Janna Sayer served as the lead analyst for this study.  Other principal 
Office of Evaluation and Inspections staff from the Atlanta regional office 
who contributed to the report include Starr Kidda and Sarah Langford; 
central office staff who contributed include Kevin Farber and Talisha 
Searcy.  
 
 
FDAs Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480)       27 
    
   
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: 
Office of Audit Services 
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.  
Office of Investigations  
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 OIGs 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  
connection with these cases, OCIG also negotiates and monitors corporate integrity agreements.  OCIG 
renders advisory opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG enforcement 
authorities.