Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

FDA’S CLEARANCE OF MEDICAL 

DEVICES THROUGH THE 510(K) 

PROCESS 

Daniel R. Levinson 

Inspector General 

September 2013 

OEI-04-10-00480 
 

EXECUTIVE SUMMARY: FDA’S CLEARANCE OF MEDICAL DEVICES 

THROUGH THE 510(k) PROCESS 

OEI-04-10-00480 

WHY WE DID THIS STUDY 

The Food and Drug Administration’s (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 FDA’s 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 FDA’s 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. FDA’s 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)). 

FDA’s 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 FDA’s 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 device’s 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). 

FDA’s 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 

sponsor’s 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 reviewer’s final decision. If the managers 

agree with the reviewer’s final decision, FDA sends a letter specifying the 

decision to the sponsor. If the managers disagree with the reviewer’s 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 CDRH’s 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). 

FDA’s 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 

of Device 

Premarket Review Process 

I Tongue depressors, 

stethoscopes 

Most are exempt from premarket review.* Nonexempt devices must be 

cleared through the 510(k) process rather than the PMA process. 

II Syringes, 

electrocardiographs 

Some are exempt from premarket review.* Nonexempt devices must be 

cleared through the 510(k) process rather than the PMA process. 

III Implantable pacemakers, 

atrial defibrillators 

In most cases, premarket approval is required. In limited circumstances, 

FDA clears Class III devices through the 510(k) process. (FDA’s 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). 

FDA’s 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). 

FDA’s 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 FDA’s 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. 

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FDA’s Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480) 7 

 

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)). 
 

 

 

 

 

 

 

 

 

 

 

 

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 

FDASIA’s enactment.39 

FDA’s 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. 

45 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).
 

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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. 

47 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 agency’s 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 FDA’s 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 

GAO’s 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.
 
 

 

 

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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 FDA’s 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 FDA’s 515 Program 

Initiative. 

We obtained the three-digit product codes identified in FDA’s 515 

Program Initiative Project Status table.49 Then, we searched FDA’s 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 FDA’s 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 FDA’s 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 FDA’s online 510(k) clearance database is at 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. 
 

 

 

 

 

 

 

 

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 

Stratum 

Number of Devices 

Cleared Through the 

510(k) Process in 2010 

Sample 

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 FDA’s 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. 

FDA’s 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. 

FDA’s 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 FDA’s 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 FDA’s 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. 

FDA’s 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 

FDA 515 Program Step Completed 

Number of Types of 

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, 

FDA’s 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 FDA’s 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 FDA’s files and during FDA’s 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. 

FDA’s Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480) 15 
 

 

FDA’s Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480) 16 

files FDA submitted electronically and FDA’s 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 FDA’s 

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. 
 

 

 

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 

device’s 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 

FDA’s 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: 

FDA’s 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 CDRH—can 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. 

FDA’s 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 FDA’s 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 FDA’s comments, see 

Appendix C. 

FDA’s 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 reviewer’s 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 FDA’s 

official Clearance Letter is included in group 3. 58 The Reviewer Cover Sheet documents the reviewer’s analysis of the device through the 

510(k) process. The Reviewer Memorandum contains the reviewer’s final summary of 

the deficiencies identified, additional information submitted by the sponsor to address the 

deficiencies, and the reviewer’s 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. 

FDA’s 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 FDA’s 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 

reviewer’s 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 FDA’s public Web site after a device is cleared. 

FDA’s 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 26Through the 510(k) Process From April 9, 2009, Through July 9, 2012, and 515 Program Initiative Steps Completed as of July Type of Class III Device 

Times Device Type Used to Clear Devices through the 510(k) Process 

Step 1 Complete 

Step 2 Complete 

Step 3 Complete 

Step Com

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 

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, 2012FDA’s 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 

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FDA’s Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480) 24 
 

 

 

 

FDA’s Clearance of Medical Devices Through the 510(k) Process (OEI-04-10-00480) 25 
 

 

 

FDA’s 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. 

FDA’s 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 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 

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.