FY 2016

PERFORMANCE REPORT

TO CONGRESS

for the

Office of 

Combination Products

as required by the

Medical Device User Fee and

Modernization Act of 2002
FY 2016 OCP Performance Report
Commissioner’s Report

I am pleased to submit the Food and Drug Administration’s (FDA or the Agency) fiscal year 

(FY) 2016 annual report to Congress for the Office of Combination Products (OCP). This report 

includes data from the thirteenth full year since OCP was established, as mandated by the 

Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, enacted on 

October 26, 2002.

Combination products are therapeutic and diagnostic products that combine drugs, devices, 

and/or biological products. Technological advances continue to merge product types and blur 

the historical lines of separation between FDA’s human medical product Centers, which are 

made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug 

Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). 

Combination products involve constituent parts that would normally be regulated under different 

types of regulatory authorities, and frequently by different FDA medical product Centers, which

raises regulatory, policy, and review-management challenges. Differences in regulatory 

pathways for each component can impact the regulatory processes for all aspects of product 

development and management, including preclinical testing, clinical investigation, marketing 

applications, manufacturing and quality control, adverse event reporting, promotion and 

advertising, user fees, and post-approval modifications.

OCP continues to enhance the transparency and predictability of the process for assigning 

combination products to the appropriate lead Center and for the review process. In this regard, 

OCP continues to facilitate interactions between industry and FDA to clearly delineate 

regulatory pathways, monitor and adjust processes to ensure timely and effective premarket 

review, and ensure the consistent and appropriate postmarket regulation of combination 

products. In addition to combination products, OCP also has classification and assignment 

responsibilities for non-combination drug, device, and biologic products.

Combination products are likely to become more complicated as new technologies emerge and 

existing technologies mature. Therefore, OCP will continue to focus on the most important 

issues relating to the regulation of combination products. OCP is committed to actively assisting 

industry and FDA reviewers in understanding the complexities of this regulatory area. 

FDA looks forward to ensuring success in meeting the unique challenges in the review and 

regulation of combination products.

FY 2016 OCP Performance Report

Scott Gottlieb, M.D.

Commissioner of Food and Drugs
FY 2016 OCP Performance Report

(This page left blank intentionally.)
Executive Summary

FDA established OCP on December 24, 2002, as required by MDUFMA. The statutory mission 

of OCP is to ensure the prompt assignment of combination products (for drug-device, biologicdevice, drug-biologic, or drug-device-biologic products) to FDA medical product Centers, the 

timely and effective premarket review of such applications, and consistent and appropriate 

postmarket regulation of these products. 

This document presents OCP’s annual report to Congress and covers activities and

accomplishments during FY 2016 (October 1, 2015, through September 30, 2016). OCP’s

activities and performance for FY 2016 that are highlighted in this report include: 

· Prompt Assignment of Combination Products. In FY 2016, OCP continued to clarify 

the jurisdictional assignment of combination products and to provide prompt Request for 

Designation (RFD) decisions. OCP issued two combination-product and two noncombination-product RFD decisions, with every assignment meeting the 60-day statutory 

decision time requirement. OCP also provided timely classification and jurisdictional 

assessments for 157 separate pre-RFD submissions.

FY 2016 OCP Performance Report

1

 To enhance the RFD process, 

OCP—in collaboration with the Office of Medical Products and Tobacco (OMPT), 

CDER’s Lean Management Staff, and the FDA medical product Centers—made

changes to our internal procedures for responding to communications from sponsors 

regarding preliminary product classification assessments from OCP. The pre-RFD 

process is the result of such cooperative efforts. 

· Timely and Effective Premarket Review. In FY 2016, OCP continued to make 

significant contributions to the premarket review of combination products by responding 

to 978 requests for assistance from Centers and sponsors. This is a 40 percent 

increase from the 700 requests received in FY 2015. OCP, in conjunction with the 

Centers, implemented major changes intended to improve the inter-Center consult 

process. The Lean Management mapping process was utilized to analyze the current 

state of the inter-Center consult processes for premarket reviews; identify potential 

causes of delays and inefficiency; and develop a revised process to enhance efficiency, 

coordination, and consistency of review of combination products. The revised process is 

in the pilot phase and is expected to be broadly implemented by the end of FY 2017. 

Other OCP activities relating to premarket review included chairing and/or participating 

in a number of inter-Center working groups to examine complex regulatory issues, 

clarifying regulatory standards, addressing challenging categories of products, 

identifying and resolving specific product issues, updating the premarket review process, 

and determining developmental considerations for combination products.

· Combination Product Review. FDA received 357 original premarket applications for 

combination products in FY 2016. This is a 5 percent increase from the 341

2

received in 

 

1

Informal requests for product classification and jurisdictional assessment/feedback are now referred to 

as “pre-RFDs” or pre-requests for designation. 

2 Refer to the appendix on page A-1 for the FY 2015 updated performance data.
FY 2015. Inter-Center consulting reviews for combination products increased to 1,130 for 

FY 2016 from 932 in FY 2015. Examples of approved combination products can be 

found on the OCP website: http://www.fda.gov/CombinationProducts/default.htm.

FY 2016 OCP Performance Report

· Consistent and Appropriate Postmarket Regulation. In FY 2016, OCP provided 

clarification and support for 50 separate postmarket matters. OCP continued to chair two 

FDA working groups to address how current good manufacturing practices (CGMPs) 

apply to combination products, which included the finalization of guidance, and also led 

cross-cutting training of compliance and inspections staff. OCP also continued to work 

with FDA’s medical product Centers to finalize the postmarket safety reporting rule for 

combination products. The group also helped to resolve postmarket safety issues, 

registration and listing issues, postmarket change submissions, and other postmarket 

regulatory issues pertaining to specific combination products.

· Additional Activities and Accomplishments. In addition, the Agency created a crosscutting decisional Combination Products Policy Council consisting of senior leaders, 

including from the FDA medical product Centers and OCP. The Council was chartered to 

discuss, resolve, and ensure implementation of solutions to complex policy questions for 

combination products. Moreover, OCP continued to conduct external outreach activities 

through a variety of educational and informational presentations to national and 

international audiences. These activities were intended to foster greater efficiency of the 

combination product development and premarket review process by enhancing 

understanding of the complex regulatory and scientific issues that arise regarding 

combination products.

OCP documented 1,028 activities in FY 2016.

3

 The topics of these activities included 

jurisdiction/classification, premarket review, and postmarket regulation. 

 

3 Some of these reported activities may have involved more than one type of activity (e.g., premarket 

review issues and postmarket regulation issues) and may be represented and/or recorded as multiple 

types of activities. The activities reported do not include formal OCP activities (e.g., responses to RFD 

submissions).
Table of Contents

Introduction................................

FY 2016 OCP Performance Report

......................................................1

Description of Combination Products ............................................................... 1

Statutorily Mandated Functions of OCP............................................................ 2

Performance Presented in This Report ............................................................ 3

Prompt Assignment of Combination Products..............................4

Requirement Workload Trends: FY 2011 to FY 2016...................................... 4

FY 2016 Review Performance.......................................................................... 6

Pre-RFD Submissions to OCP Requesting Classification and Center Assignment 

Assessments .................................................................................................... 6

OCP Requirements and Accomplishments....................................................... 9

Timely and Effective Premarket Review.........................................6

Number and Types of Combination Products under Review ............................ 6

Requirement Workload Trends: FY 2011 to FY 2016....................................... 7

Timeliness in Days of the Reviews of Combination Products......................... 14

FY 2015 and FY 2016 Review Performance .................................................. 15

OCP Requirements and Accomplishments..................................................... 16

Premarket Review Process ......................................................................... 16

Consistent and Appropriate Postmarket Regulation ..................19

Effective Resolution of Review Disputes.....................................21

Timeliness in Days of Dispute Resolutions Regarding Combination Products 21

Additional Activities and Accomplishments................................22

External Outreach........................................................................................... 23

Regulatory Initiatives ...................................................................................... 23

Appendix ......................................................................................A-1

Appendix A: FY 2015 Updated Performance Detail.......................................A-1
Acronyms

510(k) – Premarket Notifications

BLA – Biologics License Application

CBER – Center for Biologics Evaluation and Research

CDER – Center for Drug Evaluation and Research

CDRH – Center for Devices and Radiological Health

CFR – Code of Federal Regulations

CGMP – Current Good Manufacturing Practice

FDA – Food and Drug Administration

FY – Fiscal Year (October 1 to September 30)

HDE – Humanitarian Device Exemption

IDE – Investigational Device Exemption

IND – Investigational New Drug

ISO – International Organization for Standardization

MDUFA – Medical Device User Fee Amendments of 2007

MDUFMA – Medical Device User Fee and Modernization Act of 2002

NDA – New Drug Application

NSE – Not Substantially Equivalent

OCC – Office of the Chief Counsel

OCP – Office of Combination Products

PDUFA – Prescription Drug User Fee Act

PMA – Premarket Approval Application

PMC – Postmarketing Commitment

PMR – Postmarketing Requirement

RFD – Request for Designation

SE – Substantially Equivalent

FY 2016 OCP Performance Report

Introduction

On October 26, 2002, Congress enacted MDUFMA. Among other things, MDUFMA required 

FDA to establish an office “to ensure the prompt assignment of combination products to Agency 

Centers, the timely and effective premarket review of such products, and consistent and 

appropriate postmarket regulation of combination products.” In response, FDA established 

OCP within the Office of the Commissioner. Information about OCP, including the authorizing 

text of MDUFMA, can be found at the OCP website at

http://www.fda.gov/CombinationProducts/default.htm.

FY 2016 OCP Performance Report 1

Description of Combination Products

Combination products are developed to enhance the safety and effectiveness of the component

medical products. Combination products are those identified in Title 21 Code of Federal 

Regulations (CFR) § 3.2(e):

(1) A product comprised of two or more regulated components, i.e., drug/device, 

biologic/device, drug/biologic, or drug/device/biologic, that is physically, chemically, or 

otherwise combined or mixed and produced as a single entity; 

(2) Two or more separate products packaged together in a single package or as a unit and 

comprised of drug and device products, device and biological products, or biological and 

drug products; 

(3) A drug, device, or biological product packaged separately that, according to its 

investigational plan or proposed labeling, is intended for use only with an approved 

individually specified drug, device, or biological product where both are required to 

achieve the intended use, indication, or effect and where upon approval of the proposed 

product the labeling of the approved product would need to be changed, e.g., to reflect a 

change in intended use, dosage form, strength, route of administration, or significant 

change in dose; or,

(4) Any investigational drug, device, or biological product packaged separately that 

according to its proposed labeling is for use only with another individually specified 

investigational drug, device, or biological product where both are required to achieve the 

intended use, indication, or effect.

Some combination products have the potential to provide enhanced therapeutic advantages 

compared to non-combination devices, drugs, and biologics and incorporate cutting-edge, novel 

technologies that hold great promise for advancing patient care. Combination products may 

include drug-delivery systems, gene therapy systems, personalized medicine drug-device 

combinations, biological-device combinations, nanotechnology, and other innovative products 

for diagnostic and therapeutic treatment of cardiovascular, neurological, metabolic, oncologic, 

and other disorders. 
Statutorily Mandated Functions of OCP

2 FY 2016 OCP Performance Report

MDUFMA established broad responsibilities for OCP that cover the regulatory life cycle of 

combination products, including product jurisdiction decisions and duties relating to premarket 

review and postmarket oversight for these products. However, the primary responsibilities for 

scientific premarket review and postmarket regulation of combination products remain in one of 

the three FDA medical product Centers—CBER, CDER, or CDRH—to which they are assigned 

by OCP. Specifically, section 503(g)(4)(B)-(F) of the Federal Food, Drug, and Cosmetic Act 

(FD&C Act) required OCP to, among other things:

1. Promptly assign a Center with primary jurisdiction for a combination product;

2. Ensure the timely and effective premarket review of combination products by overseeing 

the timeliness of, and coordinating and overseeing progress of, reviews involving more 

than one Center;

3. Ensure the consistency and appropriateness of postmarket regulation of combination 

products;

4. Resolve disputes regarding the timeliness of premarket review of combination products; 

and

5. Review and update agreements, guidance documents, or practices specific to the 

assignment of combination products.

Among other activities, OCP serves as a focal point for addressing combination product issues 

raised by FDA reviewers and industry and works with the relevant Centers to develop guidance 

documents and regulations to clarify the regulation of combination products.

In addition, OCP has responsibility for FDA action on all RFDs submitted by industry in 

accordance with 21 CFR Part 3, “Product Jurisdiction.” This responsibility includes responding 

to requests for classification of a particular product as a biological product, device, drug, or 

combination product, as well as requests for product assignment.
Performance Presented in This Report

This section includes FY 2016 OCP activities and accomplishments in the assignment of 

combination products and in coordinating the premarket review and postmarket regulation of 

combination products. OCP is also required to provide an annual performance assessment for 

the various combination product applications. Accordingly, this section also provides 

performance information for FY 2016 and updates FY 2015 performance information for 

reporting timeliness (in days) of the reviews of combination products in the subsection “Timely 

and Effective Premarket Review.”

Consistent with the mandated functions of OCP, this section presents information and data on 

OCP activities related to:

· Prompt assignment of combination products 

o Timeliness of the assignment of combination products

· Timely and effective premarket review 

o Number and types of combination products under review

o Timeliness of the reviews of combination products

o Number of premarket reviews of combination products that involved a consulting 

Center

· Consistent and appropriate postmarket regulation 

· Effective resolution of review disputes 

o Timeliness of dispute resolutions regarding combination products

Unless otherwise noted, all performance data in this section are as of September 30, 2016.

FY 2016 OCP Performance Report 3
2 FY 2016 OCP Performance Report

Prompt Assignment of Combination Products

OCP is required to assign primary jurisdiction for combination products (i.e., Center assignment) 

based on the product’s primary mode of action (PMOA) (see 21 CFR 3.4(b)) in response to 

RFDs. RFD submissions are subject to a statutory 60-day deadline. OCP also provides 

assessments concerning product classification Center and assignment in response to preRFDs.

4

Requirement Workload Trends: FY 2011 to FY 2016

Classification and assignment workloads in FY 2016 are compared to the previous 5-year 

averages for the total number of combination product assignment requests and the total number 

of non-combination product classifications and assignment requests in the table below. Review 

workloads for both types of assignments are down compared to their respective 5-year 

averages. Specifically, the total formal combination product classifications and assignments are 

down 87 percent in FY 2016 and non-combination classifications and assignments are also 

down 80 percent for FY 2016.

OCP Requirement Workloads

5

RFD Submissions FY 11 FY 12 FY 13 FY 14 FY 15 FY 16

FY 11 to 

FY 15

5-Year 

Average

FY 16

Compared 

to 5-Year 

Average

Total Formal Combination 

Product Classifications/ 

Assignments 

27 23 17 8 2 2 15 - 87%

Total Formal NonCombination Product 

Classifications/ Assignments

12 10 14 9 7 2 10 - 80%

 

4 Responses pre-RFDs requesting assessments concerning product classification and Center assignment

do not have a required timeframe. However, OCP attempts to respond to pre-RFDs in a timeframe 

similar to RFDs (i.e., within 60 days). Information about pre-RFDs (including the timeliness of OCP 

responses to informal inquiries) is provided on page 7.

5 The decrease in RFD decisions has been accompanied by an increase in the number of pre-RFD 

assessments provided by OCP. See the section below titled “OCP Pre-RFD Requests for Classification 

and Assignment.”

4
2 FY 2016 OCP Performance Report

The total number of RFD combination 

product classifications and assignments 

issued in FY 2016 were the same as in FY 

2015 and continued to be the lowest 

number in the past 6 years. 

The total number of formal product 

classifications and assignments for noncombination products decreased in FY 2016

to the lowest number in the past 6 years.

FY 11 FY 12 FY 13 FY 14 FY 15 FY 16

Total 27 23 17 8 2 2

CBER 4 2 2 1 0 0

CDER 15 16 9 5 1 1

CDRH 8 5 6 2 1 1

0

5

10

15

20

25

30

35

40

Number of Requests

Combination Product Assignment Requests

FY 11 FY 12 FY 13 FY 14 FY 15 FY 16

Total 12 10 14 9 7 2

CBER 2 2 5 2 4 0

CDER 4 6 6 4 1 2

CDRH 6 2 3 3 2 0

0

5

10

15

20

Number of Requests

Non-Combination Product Assignment 

Requests

5
RFD workload is based on 58 RFD submissions that were received during FY 2016. Of these 

58 RFD submissions under consideration during FY 2016, decisions were issued for 4 

submissions (7 percent), 49 RFD submissions were found by OCP to have insufficient 

information for filing (84 percent), and 2 submissions were withdrawn by the sponsor prior to 

issuance of a formal decision (3 percent).

6 FY 2016 OCP Performance Report

6

 One filed RFD was undergoing review at the end of 

FY 2016, but a decision had not been issued. Furthermore, two RFDs were undergoing a 

review of completeness, but had not been filed by September 30, 2016.

FY 2016 Review Performance

In FY 2016, four RFD assignment decisions were issued for combination (two) and noncombination (two) products, all by the statutorily mandated 60-day deadline (see tables on the 

following page). The combination product assignment times were 45 and 47 days, with a 

median product assignment time of 46 days. The non-combination product assignment times 

were both 60 days.

Workload and Performance for Number of

Combination Product Assignments Issued

Determination

Product

Assignments

Issued*

Percent

on Time*

Drug-Device 2 100%

Drug-Biologic 0 NA

Device-Biologic 0 NA

Drug-Device-Biologic 0 NA

Total 2 100%

* Does not include request for reconsideration responses, 

which are issued within the 15-day time frame provided by 

21 CFR § 3.8. One request for reconsideration was 

submitted for a combination product in FY 2016.

Workload and Performance for Number of 

Non-Combination Product Assignments 

Issued

Determination

Product

Assignments

Issued*

Percent

on Time*

Drug 2 100%

Biologic 0 NA

Device 0 NA

Total 2 100%

* Does not include request for reconsideration responses, 

which are issued within the 15-day time frame provided by 

21 CFR § 3.8. No requests for reconsideration were

submitted for a non-combination product in FY 2016.

Pre-RFD Submissions to OCP Requesting Classification and Center 

Assignment Assessments7 

In addition to RFDs, OCP also provided preliminary feedback/assessments for pre-RFD 

submissions for product classification and Center assignment8in FY 2016. The pre-RFD 

 

6 Both of the RFDs were withdrawn prior to filing.

7 See footnote 1. Effective FY 2016, these requests are referred to as “pre-RFDs.” Due to this change, 

the data shown for FY 2013 through FY 2015 are now referred to as “pre-RFD” data and includes both 

internal and external requests. These requests were presented as “informal assessments” in prior OCP 

performance reports. 

8 A sponsor may obtain preliminary feedback on a product’s classification and/or Center assignment, or 

on what information to provide in an RFD, by submitting a pre-RFD to OCP.
process may be preferable to the more formal RFD process when a sponsor would like to 

engage FDA using a more interactive approach, a course that may be especially helpful when a 

medical product is at an early stage in its development or when a sponsor is contemplating 

whether to develop a specific product (or what configuration of that product to pursue). In the 

table below, OCP pre-RFD submission review workloads in FY 2016 are compared to 

the previous 3-year averages.

FY 2015 OCP Performance Report 7

9

 Total pre-RFD submissions increased by 64 percent in FY 2016 

compared to the 3-year average.

OCP Pre-RFD Submission Workload

Pre-RFD Assessments FY 13 FY 14 FY 15 FY 16

FY 13 to 

FY 15

3-Year 

Average

FY 16

Compared 

to 3-Year 

Average

Total Pre-RFD Assessments 37 113 139 157 96 +64%

 

9 Data represent pre-RFDs to which OCP received complete information and responded with feedback on 

product classification or Center assignment during the respective fiscal year. Pre-RFD submissions were 

not included in this data if they were still undergoing review or the requests contained incomplete 

information. 
OCP responded to nearly all pre-RFD submissions in a timeframe consistent with that 

mandated for formal RFDs (i.e., 60 days). The table below shows the median and average 

review times for all pre-RFD classification and Center assignment assessments issued within 

the fiscal years shown. The average time to review pre-RFD submissions increased in FY 2016 

as compared to the previous 3 years. In FY 2016, the average number of review days was 30,

and 96 percent of informal assessments decisions were answered in 60 days or less.

Pre-RFD Submission Timeliness

8 FY 2016 OCP Performance Report

Pre-RFD Assessment 

Timeliness Measures FY 13 FY 14 FY 15 FY 16

Median Review Days 10 7 20 21

Average Review Days 21 18 24 30

Percent of Assessments

Issued in 60 days 92% 94% 95% 96%
OCP Requirements and Accomplishments

FY 2016 OCP Performance Report 9

Type of Activity FY 2016 Accomplishments

Issuing required RFD assignments within 

60 days

OCP issued all RFD assignments by the statutory 60-day 

deadline.

Responding to informal stakeholder 

inquiries including, pre-RFDs

OCP responded to 712 stakeholder inquiries related to product 

classification and Center assignment. These 712 inquiries 

include 157 pre-RFDs and an additional 555 inquiries of more 

general or procedural questions relating to product classification 

and assignment, as well as queries about the classification or 

assignment of a particular product where the sponsor did not 

provide sufficient information for the Agency to provide feedback. 

This represents a 50 percent increase in informal inquiries for 

classification and Center assignment compared to FY 2015.

Clarifying standards for product 

classification and preparing guidance on 

this issue

OCP continued to chair a working group including staff from 

CDER, CDRH, CBER, and the Office of Chief Counsel (OCC) to 

clarify interpretive standards’ address classification and 

assignment of challenging categories of products; and pursue 

related policy initiatives, including developing guidance on how 

FDA determines whether a product is a drug, device, biological 

product, or combination product, and to clarify standards for 

cross-labeled combination product status. OCP participated in a 

Part 15 panel and continued to participate in an FDA working 

group on developing guidance to clarify classification standards 

for human tissue products.

Enhancing the timeliness, consistency, 

and clarity of jurisdictional decisions 

across FDA

OCP continued to facilitate product classification and 

jurisdictional meetings with CBER, CDER, CDRH, and OCC staff 

to exchange information and discuss challenging product 

classification and Center assignment issues before the FDA. 

OCP continued to provide training to review staff, including 

personnel from CBER, CDER, and CDRH, as well as Office of 

Regulatory Affairs inspectors, on product classification and

Center assignment.
Timely and Effective Premarket Review

OCP is responsible for ensuring the timely and effective premarket review of combination 

products, including overseeing the timeliness of reviews and coordinating reviews involving 

more than one Center. In 2002, FDA established policies and procedures for FDA staff to follow 

when requesting, receiving, handling, processing, and tracking formal reviews of combination 

products, devices, drugs, and biologics. This policy was formally incorporated into the FDA 

Staff Manual Guide, Agency Program Procedures, Volume IV, effective June 18, 2004, and is 

available on the FDA website at

http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/ucm135860.htm.

10 FY 2016 OCP Performance Report

10

Number and Types of Combination Products under Review

FDA is required to report the number and types of combination products under review. The 

following information refers to FDA performance presented in this subsection.

· The number and types of combination products under review for FY 2016 by CBER, CDER, 

and CDRH included submissions filed or received in FY 2016. The number of combination 

product submissions is a small subset of the total number of medical product submissions 

received by FDA. 

· When reporting timeliness in days of the review for CBER-led or CDER-led combination 

products, Prescription Drug User Fee Act (PDUFA V) goals are referenced for priority and 

standard new drug applications (NDAs) and biologics license applications (BLAs). With 

CBER-led or CDRH-led combination products, MDUFA III goals are referenced for 

expedited and original premarket approval applications (PMAs), premarket notifications 

(510(k)s), and device BLAs. Performance goals apply to only a subset of applications of a 

certain type. Therefore, not every application is required to be reviewed in accordance with 

a user fee-related time frame.

· Some product review goals, such as for NDAs, are defined by number of months. Due to 

the differences in the numbers of days in each month (28 to 31), 10 months represents a 

range from 304 days (such as February 1 to December 1) to 306 days (such as March 15 to 

January 15), and 6 months represents a range from 182 days (such as February 15 to 

August 15) to 184 days (such as July 15 to January 15).

· Median review time is based on FDA first cycle review performance for PDUFA V goals. For 

MDUFA III goals, median review times are based on total MDUFA III decision review time. 

Actual review time is used when only one action was measured.

 

10 On December 13, 2016, during FDA’s 2017 fiscal year, the 21st Century Cures Act was signed into law. Section 

3038 of this legislation amended section 503(g) of the FD&C Act (21 USC 353(g)), the principal provision of the 

FD&C Act with respect to combination products. The amendments to section 503(g) included some additions to the 

congressional reporting requirements for OCP. Among other changes, consistent with these additional reporting 

requirements, the FDA FY 2017 report will include, for combination products, data on timely and effective 

premarket review of abbreviated new drug applications (see FD&C Act section 505(j) (21 USC 355(j)) and de novo 

classifications (see FD&C Act section 315(f) (21 USC 360c(f)).
Requirement Workload Trends: FY 2011 to FY 2016

Review workloads in FY 2016 are compared to the previous 5-year averages for the total 

combination products submitted for review and the total inter-Center consult requests in the 

table below.

OCP Requirement Workloads

FY 2016 OCP Performance Report 11

Submission/Request FY 11 FY 12 FY 13 FY 14 FY 15* FY 16

FY 11 to 

FY 15

5-Year 

Average

FY 16 

Compared 

to 5-Year 

Average

Total Combination Products 

Submitted for Review by 

Centers

285 264 313 317 341 357 304 + 17%

Total Inter-Center Consult 

Requests 530 660 828 1,013 932 1,130 776 + 42%

* FY 2015 numbers were changed to reflect updates to data presented in the FY 2015 OCP performance report.

The total number of combination products 

submitted for review increased in FY 2016. 

Of the combination product application 

submissions received and categorized, 61 

percent were led by CDER, followed by 

CDRH (28 percent) and CBER (11 percent).

The total number of inter-Center consult 

requests increased in FY 2016 to the 

highest number in the past 6 years. The 

number of inter-Center consults increased 

by 42 percent as compared to the previous 

5-year average.

FY

11

FY

12

FY

13

FY

14

FY

15

FY

16

Total 285 264 313 317 341 357

CBER 38 38 37 44 37 39

CDER 133 117 136 147 175 218

CDRH 114 109 140 126 129 100

0

100

200

300

400

Number of Submissions

Combination Product Application 

Submissions

FY

11

FY

12

FY

13

FY

14

FY

15

FY

16

Total 530 660 828 1013 932 1130

CBER 51 40 31 48 53 74

CDER 220 350 506 643 499 754

CDRH 259 270 291 322 380 302

0

100

200

300

400

500

600

700

800

900

1000

1100

1200

Number of Requests

Inter-Center Consultation Requests
The table below reflects the number of Inter-Center consult request forms used during FY 2016,

broken down by primary assigned Center and which Center requested the consult.

12 FY 2016 OCP Performance Report

11

Number of Premarket Reviews of Combination Products by Requesting and Assigned Center

Primary 

Assigned 

Center

CBER

Consulted

CDER

Consulted

CDRH

Consulted

Number of 

Consults

CBER -- 7 2 9

CDER 28 -- 300 328

CDRH 46 747 -- 793

Total 74 754 302 1,130

 

11 Some applications were associated with multiple consulting requests. Additionally, because these 

consulting requests are associated with any combination product under review for which consultative or 

collaborative review is needed, regardless of the date of FDA receipt of the application, the number of 

requests is not directly comparable to the number of combination product applications received during 

FY 2016, as reported in the previous section.
The table below reflects the 357 original applications for combination products received in FY 

2016 under the identified seven application types, and presents their initial classification into 

one of nine categories.12 The same table reflecting applications received in FY 2015 is updated 

in Appendix A to reflect corrections and actions as of September 30, 2016. The majority of the 

applications (62 percent) were original INDs, followed by original 510(k)s (21 percent) and 

original IDEs (8 percent). The most common combination product category was possible 

combination based on mutually conforming labeling of separate products (25 percent), followed 

by device coated/impregnated/otherwise combined with drug (21 percent).

Workload by Combination Product Category Number

Combination Product Category Key: 

1 = convenience kit or co-package

2 = pre-filled drug delivery device/system

 3 = pre-filled biologic delivery device/system

4 = device coated/impregnated/otherwise 

combined with drug

 5 = device coated or otherwise combined with 

biologic

FY 2016 OCP Performance Report 13

 6 = drug/biologic combination

 7 = separate products requiring mutually 

conforming labeling

8 = possible combination based on mutually 

conforming labeling of separate products

9 = other type of combination product

12

 

12 The classifications are presented as “initial” because adjustments are made to these numbers for each 

fiscal year to reflect corrections and subsequent actions that may inform classification status, such as the 

ultimate status of products initially placed in category 8 (for certain possible combination products). An 

updated version of the same table for applications received in FY 2015 is provided in Appendix A to 

reflect corrections and actions as of September 30, 2016. 

Application Type 1 2 3 4 5 6 7 8 9 Totals

Original NDAs 5 13 0 0 0 0 0 0 1 19

Original BLAs 1 0 7 0 1 0 0 0 0 9

Original PMAs 0 0 0 3 1 0 0 0 0 4

Original 510(k)s 9 0 0 51 1 0 10 1 2 74

Original INDs 5 54 14 11 0 51 1 83 2 221

Original IDEs 2 0 0 11 4 0 2 6 5 30

Original HDEs 0 0 0 0 0 0 0 0 0 0

Totals 22 67 21 76 7 51 13 90 10 357
Timeliness in Days of the Reviews of Combination Products

FDA is required to report the timeliness in review time for combination products. The table 

below summarizes the review type and review performance target for original NDAs, BLAs, 

PMAs, and 510(k)s. PDUFA V and MDUFA III established review performance goals for many 

types of drug, device, and biological product premarket applications. These goals reflect current 

expectations about the portion of premarket applications that will be reviewed within a specified 

time frame. Performance goals apply to only a portion of all applications of a certain type, and 

they do not require that every application be reviewed in accordance with the applicable time 

frame. Typical goals range from 50 percent to 90 percent and vary by year. 

For MDUFA III performance goals, refer to:

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM2954

14 FY 2016 OCP Performance Report

54.pdf. 

For PDUFA V performance goals, refer to:

http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.

Performance Goals for Original Applications†

User Fee Act Original 

Application Type Review Type Review Within

PDUFA V NDAs Priority 6 months

PDUFA V NDAs Standard 10 months

PDUFA V BLAs Priority 6 months

PDUFA V BLAs Standard 10 months

MDUFA III Expedited and Original PMAs

Decision for PMA Filed 

Submissions with no Advisory 

Committee Input

180 days

MDUFA III Expedited and Original PMAs

Decision for PMA Filed 

Submissions with Advisory 

Committee Input

320 days

MDUFA III 510(k)s SE or NSE decision* 90 days

MDUFA III BLAs Priority 6 months

MDUFA III BLAs Standard 10 months

* Substantially equivalent (SE) or not substantially equivalent (NSE)

† The timelines to take action for BLAs that fall under the MDUFA III timeline are 6 months from receipt for a priority review and 

10 months for a standard review. The timelines for NMEs and BLAs that fall under PDUFA V’s “Program” Review Model are 

10 months for standard applications and 6 months for priority reviews from the 60-day filing date (or 12 months and 8 months 

respectively from the date of submission of the application) input.

FDA review of performance information, with respect to premarket review, for CBER, CDER, 

and CDRH is based on a fiscal year receipt cohort. This methodology calculates performance 

information for submissions for the fiscal year FDA received them, regardless of when FDA 

acted on or approved the submissions. This section updates FDA’s review performance on the 

FY 2015 combination product submissions and presents FDA’s review performance on the 

FY 2016 combination product submissions through September 30, 2016.
FY 2016 OCP Performance Report 15

FY 2015 and FY 2016 Review Performance

Final FY 2015 review goal performance is presented in the table below and was similar between 

FY 2015 and FY 2016. 

Original 

Application Type

Review

Type

Review 

Within

Number of 

Combination 

Products*

Median or 

Actual Review 

Time (Days)

Range of 

Review Time

(Days)

NDAs Priority 6 months 5 181 121 to 336

NDAs Standard 10 months 16 305 301 to 397

BLAs Priority 6 months 1 242 242

BLAs Standard 10 months 3* 365 359 to 455

Expedited and 

Original PMAs FDA Decision 180 or 320days† 8* 339 171 to 380

510(k)s SE or NSE Decision 90 days 75* 83 13 to 110

* FY 2015 numbers were changed to reflect updates to data presented in the FY 2015 OCP Performance Report. 

† Review within 180 days for decisions without Advisory Committee input and review within 320 days for decisions with 

Advisory Committee input.

Preliminary FY 2016 review goal performance is presented in the table below.

Original 

Application Type

Review

Type

Review 

Within

Number of 

Combination 

Products

Median or 

Actual Review 

Time (Days)

Range of 

Review Time

(Days)

NDAs Priority 6 months 3 174 165 to 183

NDAs Standard 10 months 16 304 303 to 304

BLAs Priority 6 months 2* 0 0

BLAs Standard 10 months 7 334 303 to 364

Expedited and 

Original PMAs FDA Decision 180 or 320days† 4* 177 177

510(k)s SE or NSE Decision 90 days 74 86 9 to 101

* Included in this count are BLAs and 510(k)s that are pending filing since the assumption is that they will go on to be filed. 

These are preliminary numbers that may change if reporting filed figures differ from receipt figures.

† Review within 180 days for decisions without Advisory Committee input and review within 320 days for decisions with 

Advisory Committee input.
OCP Requirements and Accomplishments

Premarket Review Process

OCP continued to facilitate the premarket review processes for combination products having 

complex regulatory issues. OCP fostered early interactions between industry and FDA to 

develop clearly delineated regulatory pathways for the development and expeditious review of 

premarket submissions for combination products. Responding to requests from both industry 

and FDA review staff, OCP provided guidance on unique regulatory issues presented by 

combination products such as the number of marketing applications, labeling requirements, 

human factor testing and pre-clinical testing requirements. OCP led or participated in meetings 

and discussions to ensure continued and consistent communication between sponsors and FDA 

review staff. OCP FY 2016 accomplishments related to premarket review are included in the 

table below.

16 FY 2016 OCP Performance Report

Type of Activity FY 2016 Accomplishments

Developing guidance 

and regulations

OCP chaired a cross-Center working group to develop a guidance document to 

clarify the role of human factors studies for combination products. In February 

2016, OCP, along with the FDA medical product Centers, issued the draft 

guidance “Human Factors Studies and Related Clinical Study Considerations in 

Combination Product Design and Development,” available at.

https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm484345.pdf

(See also the discussion of CGMP-related guidance and training under the 

“Consistent and Appropriate Postmarket Regulation” section.)

Responding to requests 

for assistance from 

Centers and sponsors 

relating to premarket 

review issues13

OCP received 978 requests for assistance, the responses to which contributed 

to ensuring the timely and effective review of combination products. OCP 

addressed issues related to: novel drug and biological product delivery systems, 

photodynamic therapy, wound healing products, generic drugs that include 

devices, consistency and clarity of labeling, and developmental considerations 

for combination products with mobile communication technologies.

Developing possible 

regulatory pathways for 

new products intended 

to be used with another 

sponsor’s alreadyapproved product

OCP continued to work with the Centers and OCC to assess approaches for 

resolving complex legal and public health issues associated with the marketing 

of products intended for use with other legally marketed products, including 

assessing the appropriateness of different marketing authorization pathways, 

labeling, and coordination with and between product sponsors. OCP also 

participated in Agency efforts to work with the imaging product industry on 

specific considerations relating to combined use of imaging devices with 

imaging agents.

 

13 The number of premarket activities reported in this section includes the 712 stakeholder jurisdictional 

inquiries reported above. This is because, generally, product classification and jurisdictional 

determinations are requested and made in the premarket setting.
FY 2016 OCP Performance Report 17

Type of Activity FY 2016 Accomplishments

Participating in other 

inter-Center and 

Agency-wide working 

groups to clarify issues 

related to combination 

products

OCP participated in inter-Center working groups to develop policies and 

technical guidance on topics that include: biological products and tissues, 

product labeling, wound care products, flow restrictors, metered dose inhalers 

and dry powder inhalers, guidance and citizen petition responses for specific 

types of generic combination products, guidance on comparative human factors 

studies for generic drug-led and interchangeable biologic-led combination 

products, and a final rule on the use of symbols in device and device-led 

combination product labeling. OCP also participated in Agency-wide working 

groups such as FDA’s Task Force on Antimicrobial Resistance and a workgroup 

focused on classification of certain wound care products containing 

antimicrobials. 

OCP participated in the CDER development of guidance for “Selection of the 

Appropriate Package Type Terms and Recommendations for Labeling 

Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and 

Single-Patient-Use Containers for Human Use,” available at: 

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugsgen/documents/document/ucm468228.pdf.

OCP and CDRH participated in the CDER electronic submission working group 

to further clarify where to provide device constituent part information when using 

the CDER/CBER ECTD format. The revised September 2016 guidance 

document, “Providing Regulatory Submissions in Electronic Format —Certain 

Human Pharmaceutical Product Applications and Related Submissions Using 

the eCTD Specifications,” is available at:

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ 

FormsSubmissionRequirements/ElectronicSubmissions/UCM465411.pdf

Serving as a resource 

for FDA staff on the 

appropriate use and 

interpretation of 

combination product 

categorization for 

premarket submissions

OCP assisted staff in CBER, CDER, and CDRH in determining the correct 

combination product categories for data reporting purposes. 

Practice of the Inter-Center Review Process

OCP oversees inter-Center consults to ensure that review of premarket applications are 

completed in a timely manner and meet PDUFA V and MDUFA III timelines. Specifically, OCP 

tracks and monitors all ongoing inter-Center consult requests; clarifies internal operating 

procedures, roles, and responsibilities; identifies consulting divisions and contacts; clarifies due 

dates and completion status; facilitates access to review documents; and responds to industry 

inquiries. Other areas of OCP involvement, on a less routine basis, include clarifying the impact 

of goal differences under PDUFA V and MDUFA III and resolving barriers to timely completion 

of consultation requests. OCP responded to external requests to host cross-Center early 

development meetings on bundled issues to minimize redundant product meetings. 

In addition to providing general consult process assistance and facilitating inter-Center 

communication, OCP also provided assistance to the Centers in resolving regulatory and 

scientific issues relating to specific combination products and to specific categories of 

combination products.
18 FY 2016 OCP Performance Report

Type of Activity FY 2016 Accomplishments

Consultative/collaborative 

review process

· Actively tracked, monitored, and followed up on a total of 1,130 interCenter consult requests on combination products under review to 

ensure the requesting Center received timely feedback. 

Providing significant 

facilitation or assistance

Provided significant assistance with respect to the following categories of 

products and other premarket regulatory issues:

· Novel drug-device cancer therapies

· Injector delivery systems (including intrathecal systems)

· Traditional products with novel combination uses 

· Medical imaging drugs and devices 

· Coordination of premarket CGMP inspections 

· Import-export of combination products or their constituent parts

· Inter-Center compliance and safety evaluator processes for premarket 

evaluation and postmarket safety matters 

· Registration and listing and associated information technology 

considerations

· Regulatory considerations for a monograph drug for use with a device 

constituent part or for a Class I device for use with a drug

· Risk determination and need for investigational application 

assessments

· Unique device identifiers and standardized numerical identification

· Application of IND and IDE requirements for combination products

· Application of 21 CFR Part 4 to premarket submissions under review

· CDRH development of guidance on premarket regulation of drugeluting stents

Development of

consultative/collaborative 

review process and 

procedures 

· OCP chaired a working group on consultation for containers/closures 

that also deliver drugs/biologics.

· OCP participated in an Agency working group, utilizing the Lean 

Management mapping process, to examine, revise, and enhance the 

inter-Center consult process. Additionally, significant improvements 

were made to the form used to manage consults between Centers.

· OCP lead efforts to improve staff access to IT systems needed for the 

review of combination products.

· OCP, along with the Office of the Commissioner and the FDA medical 

product Centers, initiated a pilot for adjustments to the inter-Center 

consult process intended to enable timely and consistent coordination 

to generate effective submission reviews.
Consistent and Appropriate Postmarket Regulation

OCP is tasked with ensuring the consistency and appropriateness of postmarket regulation of 

combination products. OCP meets this requirement by undertaking a variety of compliancerelated and postmarket activities to help ensure the safety and quality of combination products. 

The compliance-related and postmarket activities include leading Agency efforts to develop and 

publish regulations and guidance for postmarket safety and CGMPs for combination products,

coordinating and overseeing FDA actions relating to novel and complex postmarket safety 

issues and CGMP compliance questions, and facilitating and leading meetings between industry 

and FDA regarding these matters. These activities include providing support to FDA field 

inspectors for products seized at ports of entry to stop illegal products from entering the United 

States, responding to product defect issues, providing guidance on enforcement issues relating 

to import requirements, and providing warning letter review. OCP FY 2016 accomplishments 

related to the consistency and appropriateness of postmarket regulation are included in the 

table below.

FY 2016 OCP Performance Report 19

Type of Activity FY 2016 Accomplishments

Providing clarification and 

support on separate 

postmarket matters to 

ensure consistent and 

appropriate postmarket 

regulation of combination 

products

OCP addressed 50 postmarket-related matters involving such issues as 

the application of CGMPs and quality system regulations for inspections 

of combination products, appropriate mechanisms and manufacturer 

responsibilities for reporting adverse events, and requirements for 

registration and listing.

Developing regulations

In FY 2016, OCP continued to work with OCC and the Centers on 

clearance of a final rule on postmarketing safety requirements for 

combination products. OCP also worked with Centers to update 

information technology systems to support tracking, sharing, and 

assessment of safety reports for combination products.

Guidance development

· OCP chaired a working group to prepare final guidance on CGMP 

and to augment associated training materials for investigators and 

compliance staff. 

· OCP and Center experts presented training to FDA field and 

headquarters staff on CGMPs. The final guidance “Current Good 

Manufacturing Practice Requirements for Combination Products,”

along with enhanced training, is intended to facilitate timely, 

effective premarket review of combination products subject to 

premarket authorization by FDA. 

· OCP also continued to co-chair a committee on combination 

products of the Association for the Advancement of Medical 

Instrumentation (AAMI) that prepared TIR (Technical Information 

Report) 48 on CGMPs for combination products. Published by 

AAMI in 2016, the report is targeted to combination products 

manufacturers to help outline best practices with respect to CGMP 

obligations. The committee also began work on a TIR on risk 

management for combination products.

· OCP also continued to work with Centers on guidance for 

combination product registration and listing and on finalization of 

the draft guidance on postmarket change submissions for 

combination products.
20 FY 2016 OCP Performance Report

Type of Activity FY 2016 Accomplishments

Procedures development

Safety signals for combination products are submitted to CBER, CDER, 

and CDRH. OCP promoted consistency in the evaluation of adverse 

events and resolution of postmarket safety issues through coordination 

efforts and provision of regulatory guidance. 
Effective Resolution of Review Disputes

When requests are received, OCP is required to resolve disputes regarding the timeliness of the 

premarket review of a combination product. OCP facilitates communications between sponsors 

and FDA review staffs to identify, clarify, and resolve specific concerns associated with review 

timeliness. The facilitation of issues helps prevent the need for more formal dispute resolution.

In addition to disputes related to timeliness, OCP may also receive requests for dispute 

resolution and/or mediation for other review issues (e.g., inter-office review dispute resolution or 

requests by product sponsors for assistance in understanding a review division’s intent 

regarding issued decisions).

Timeliness in Days of Dispute Resolutions Regarding Combination 

Products

FDA is to report the timeliness in days of dispute resolutions regarding combination products. 

For the thirteenth consecutive year, no formal requests to resolve a dispute regarding the 

timeliness of a combination product review were received during FY 2016. The “Timely and 

Effective Premarket Review” section of this report provides examples of informal facilitation and 

resolution of issues related to premarket review.

FY 2016 OCP Performance Report 21
Additional Activities and Accomplishments

OCP officially documented activities performed during FY 2016. These are summarized in the 

table below. 

Number of OCP Documented Activities*

22 FY 2016 OCP Performance Report

OCP Activities FY 11 FY 12 FY 13 FY 14 FY 15 FY 16

FY 11 to 

FY 15

5-Year 

Average

FY 16

Compared 

to 5-Year 

Average

Total Activities by 

Stakeholder14 682 756 603 760 847 1028 730 + 41%

Total Activities by Issue Type

Jurisdiction/Classification 

Assignments and 

Issues15,16

265 268 233 248 475 712 298 + 139%

Premarket Review 

Issues 495 388 390 650 700 978 525 + 86%

Postmarket Regulation 

Issues 57 33 57 110 71 50 66 - 24%

* Some of these reported activities may have involved more than one type of activity (e.g., premarket review issues and 

postmarket regulation issues) and may be represented and/or recorded as multiple types of activities.

In addition to the required functions noted previously, OCP actively pursues strategies intended 

to further program objectives internally and externally. Although not exhaustive of all of OCP’s 

supplemental activities, the information below highlights additional FY 2016 OCP 

accomplishments with regard to two categories of efforts: external outreach and regulatory 

initiatives.

 

14

“Total Activities by Stakeholder” represents the sum of the Premarket Review Issues and Postmarket 

Regulation Issues categories. The activities reported do not include formal OCP activities (e.g., 

responses to RFD submissions).

15 The “Jurisdiction/Classification Assignments and Issues” category listed in the table is a subset of the 

larger “Premarket Review Issues” category. 

16 The “Jurisdiction/Classification Assignments and Issues” category include all inquiries to OCP for the 

respective fiscal year that pertain to product classification and jurisdiction issues. As such, inquiries are 

included regardless of whether a product classification and jurisdictional decision was issued (e.g., 

pending decisions, inquiries for which additional information was requested, requests from FDA medical 

product Centers regarding whether a jurisdictional assessment would be needed). The 157 inquiries for 

FY 2016 (reported elsewhere in the Executive Summary) that resulted in informal product classification 

and jurisdictional assessment decisions are included in the total number of issues provided.
External Outreach

OCP conducts outreach activities to share information on FDA assignment and regulation of 

combination products by participating in industry conferences and meeting with trade 

associations and coalitions representing the drug, device, biological product, and combination 

product industries (e.g., Combination Products Coalition, Advanced Medical Technology 

Association, Association for Advancement of Medical Instrumentation). Discussions and 

presentations focus on a wide range of topics, including emerging issues in combination product 

regulation, the role of OCP, policies and guidances under consideration, rulemaking, companion

diagnostics, injector clinical development options, standards, and future industry needs. 

Examples of FY 2016 outreach activities are included in the tables on the following pages.

FY 2016 OCP Performance Report 23

Type of Activity FY 2016 Accomplishments

Presentations and outreach 

activities

OCP participated in a number of outreach activities. The following are 

examples of some notable venues/events for which OCP provided 

presentations and/or educational outreach:

· Association for the Advancement of Medical Instrumentation/FDA 

International Conference on Medical Device Standards and Regulation 

· Drug Information Association Fourth Annual Conference on Combination 

Products

· Parenteral Drug Association/FDA Joint Regulatory Conference

· Informa Annual Conference on Combination Products

· Drug Information Association Annual Meeting 

· NIH Neuroscience Forum: Developing Multimodal Therapies for Brain 

Disorders

· Ministry of Foreign Affairs of Denmark FDA Seminar on Combination 

Products

· FDLI 2016 Annual Conference

Regulatory Initiatives

OCP activities include efforts to assist in advancing initiatives important to and affecting the 

regulation of combination products. Examples of regulatory activities pursued in FY 2016 are

included in the following table.
24 FY 2016 OCP Performance Report

Type of Activity FY 2016 Accomplishments

Continuing to contribute to the 

advancement of innovative product 

initiatives

· OCP participated in an assessment of the procedures for 

sponsors to obtain informal feedback on product 

classification and assignment, in support of the pre-RFD 

program. 

· OCP assisted in determining the appropriate regulatory 

pathway for novel technology diagnostics and biomarkers 

under review for use with drug or biological products. 

· OCP worked with the Center for Tobacco Products, 

CDER, CDRH, and other FDA components on 

classification issues relating to e-cigarettes and products 

that include tobacco, drugs, and devices.

· OCP participated on working groups chaired by Centers 

to clarify common issues such as considerations for 

visualization of particulates in injectable solutions.

· OCP provided assistance on combination product 

considerations for guidance and regulations developed by 

Centers. Topics included the development and premarket 

review of companion diagnostics and other products 

intended for use with other products, unique identifiers for 

devices and combination products that include them, 

regulation of biosimilar biological products, generic 

developmental issues, and expanding non-prescription 

access to drugs.

· OCP coordinated development of consistent trial designs 

for certain novel delivery systems dedicated to cancer 

chemotherapeutics.

· OCP provided internal feedback on ISO standards 

development for certain syringes.

· OCP provided input into the 21st Century Cures Act and 

other innovative legislative initiatives relating to the 

regulation of combination products.

· OCP participated in the Lean Management initiatives to 

revise standard operating procedures for jurisdiction 

assessments and the inter-Center consult requests/review

process.

Continuing to actively participate in 

Agency information technology 

initiatives

OCP continued to coordinate and participate in cross-cutting 

information technology initiatives. Such initiatives are aimed at

enhancing the infrastructure necessary to improve the efficiency, 

consistency, and reliability of information systems and 

communications within and among FDA medical product Centers 

and between FDA and combination product sponsors and other 

interested stakeholders.
FY 2016 OCP Performance Report 25

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Appendix

Appendix A: FY 2015 Updated Performance Detail

The table below reflects the 341 original applications initially classified into one of nine 

categories of combination products received in FY 2015.

Workload by Combination Product Category Number

Workload by Center Lead The pie chart to the right shows the 

number and percentage of combination 

product applications in FY 2015 by 

Center lead, as of September 30, 2016.

FY 2016 OCP Performance Report A-1

CBER 

37 

(11%)

CDER 

175

(51%)

CDRH

129 

(38%)

Combination Product 

Applications (n = 341)

Application Type 1 2 3 4 5 6 7 8 9 Totals

Original NDAs 6 13 0 1 0 0 1 0 0 21

Original BLAs 0 0 4 0 0 0 0 0 0 4

Original PMAs 0 0 0 6 0 0 2 0 0 8

Original 510(k)s 8 0 0 57 0 0 5 1 8 79

Original INDs 9 50 18 4 4 40 3 48 5 181

Original IDEs 1 0 0 24 3 0 9 5 4 46

Original HDEs 0 0 0 0 0 0 2 0 0 2

Totals 24 63 22 92 7 40 22 54 17 341

Combination Product Category Key: 

1 = convenience kit or co-package

2 = pre-filled drug delivery device/system

 3 = pre-filled biologic delivery device/system

4 = device coated/impregnated/otherwise 

combined with drug

 5 = device coated or otherwise combined with 

biologic

 

 6 = drug/biologic combination

 7 = separate products requiring mutually conforming 

labeling

8 = possible combination based on mutually conforming 

labeling of separate products

9 = other type of combination product 

 

Department of Health and Human Services

Food and Drug Administration

This report was prepared by FDA’s Office of Combination Products in collaboration with the Office of 

Planning, the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, 

and the Center for Devices and Radiological Health. For information on obtaining additional copies 

contact:

Office of Planning

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, Maryland 20993-0002

Phone: 301-796-4850

This report is available on the FDA Home Page at: www.fda.gov and

the OCP Home Page at: www.fda.gov/CombinationProducts/default.htm.