FY 2017

PERFORMANCE REPORT

TO CONGRESS

for the

Office of 

Combination Products

as required by the

Medical Device User Fee and

Modernization Act of 2002

Report

The Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2017 Annual Report 

to Congress for the Office of Combination Products (OCP) includes data from the 14th full year 

since OCP was established, as mandated by the Medical Device User Fee and Modernization 

Act of 2002, P.L. 107-250 (MDUFMA), enacted on October 26, 2002.

Combination products are therapeutic and diagnostic products that combine a drug, device, 

and/or biological product. 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 Centers, which can raise 

regulatory, policy, and review management challenges. Differences relating to the regulatory 

pathways and considerations for each type of constituent part (drug, device, biological product)

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 efficiency, consistency, transparency and predictability of the 

process for assigning combination products to the appropriate lead Center and for the 

regulatory 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. 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. 

 
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Executive Summary

FDA established the Office of Combination Products (OCP) on December 24, 2002, as required 

by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The statutory 

mission of OCP is to ensure the prompt assignment of combination products (for drug-device, 

biologic-device, drug-biologic, or drug-device-biologic products) to FDA Centers, the timely and 

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

regulation of these products, after approval. 

This document presents OCP’s Annual Report to Congress and covers activities and 

accomplishments during FY 2017 (October 1, 2016-September 30, 2017). OCP’s activities and 

performance for FY 2017 that are highlighted in this report include: 

• Prompt Assignment of Combination Products. In FY 2017, OCP continued to clarify 

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

Designation (RFD) decisions. OCP issued 5 combination products and 3 noncombination product RFD decisions, with every assignment meeting the 60-day statutory 

decision time requirement. OCP also provided timely classification and jurisdictional 

assessments for 78 separate Pre-Request for Designation (Pre-RFD) submissions.1

 To 

enhance the RFD process, OCP in collaboration with the Office of Medical Products and 

Tobacco (OMPT), Center for Drug Evaluation and Research (CDER) Lean Enterprise 

Institute (LEAN) management mapping process, and the medical product Centers made 

some changes to our internal procedures for responding to communications from 

sponsors regarding preliminary product classification assessments from OCP. The PreRFD process is the result of these cooperative efforts. The revised process was 

communicated to stakeholders in a draft Pre-RFD guidance document issued in January

2017. In addition, to facilitate product classification and assignment, FDA issued a final 

guidance in September 2017, on classification of products as drugs and devices and 

additional product classification issues. 

• Timely and Effective Combination Product Review. In FY 2017, OCP received 525 

requests for product-specific assistance, the responses to which contributed to ensuring 

the timely and effective review of combination products. This is a 97 percent increase 

from the 266 requests received in 2016. OCP, in conjunction with the Centers and 

OMPT, identified mechanisms to improve the inter-center consult process. LEAN was 

utilized to analyze the then 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 was piloted through the end of FY 2017 and 

was expected to be fully implemented in light of the pilot results by early in FY 2018. 

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,

 

1 Informal requests for product classification and jurisdictional assessment/feedback are now referred to as “preRFDs” or pre-requests for designation. 
identifying and resolving specific product issues, updating of the premarket review 

process, and developmental considerations for combination products.

FDA received 561 original premarket applications for combination products in FY 2017. 

This reflects a 69 percent increase from the 330 applications of the types reported in FY 

2016 and the new inclusion in the FY 2017 report of data on two additional application 

types, abbreviated new drug applications and de novo classifications.2

 Inter-center 

consulting reviews for combination products increased to 1,419 for FY 2017 from 1,130 in 

FY 2016. Examples of approved combination products can be found at the OCP Web 

site www.fda.gov/CombinationProducts/default.htm.

• Consistent and Appropriate Postmarket Regulation. In FY 2017, OCP provided 

clarification and support for 74 separate postmarket matters. OCP continued to chair 

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

postmarketing safety reporting (PMSR) requirements to combination products. FDA 

published a final rule on PMSR for combination products in December 2016, and a final 

guidance on CGMPs for combination products in January 2017. OCP also continued to 

work with the medical product Centers on registration and listing issues, postmarket 

manufacturing compliance, and other postmarket regulatory issues pertaining to specific 

combination products.

• Procedural and Policy Activities and Accomplishments. The Agency created a 

cross-cutting decisional Combination Products Policy Council (CPPC), consisting of 

senior leaders from all three medical product Centers, OMPT, Office of Special Medical 

Programs (OSMP), and OCP in FY 2016. The CPPC continued to provide direction 

regarding complex policy and procedural questions for combination products, relating to 

the implementation of section 3038 of the 21st Century Cures Act (the Cures Act), human 

factors, the inter-center consult process, availability of premarket pathways for 

combination products, and inter-component coordination on cross-cutting policy activities. 

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 also continued to work 

with foreign counterparts, providing technical assistance and opportunities to foster 

regulatory convergence.

 

2 FY 2016 numbers were changed to reflect updates to data presented in the FY 2016 OCP Performance Report. 

The updated data for FY 2016 is located in Appendix A.
Table of Contents

Introduction ......................................................................................... 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 2012 to FY 2017 ...................................... 4

Pre-RFD Workload Performance...................................................................... 6

OCP Performance on Internal Center-Requested Classification and Assignment 

Consultations ................................................................................................... 8

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

Combination Product Pre-Market Review .....................................10

Number and Types of Combination Products Submitted for Review...............10

Requirement Workload Trends: FY 2012 to FY 2017 .....................................11

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

FY 2016 and FY 2017 Review Performance ..................................................16

Premarket Review..........................................................................................17

Combination Product Postmarket Activities................................. 18

Effective Resolution of Review Disputes ......................................20

Percentage of Combination Products for which a Dispute Resolution was Requested

.......................................................................................................................20

Policy Activities and Accomplishments........................................21

Regulatory Initiatives ......................................................................................21

Additional Premarket Review Regulatory Initiatives .......................................22

Additional Postmarket Review Regulatory Initiatives......................................23

Additional Activities and Accomplishments................................. 24

Information Technology..................................................................................24

External Outreach ..........................................................................................24

Appendix............................................................................................26

Appendix A: FY 2016 Updated Performance Detail........................................26
Acronyms

510(k) –Premarket Notifications

ANDA – Abbreviated New Drug Application

BLA – Biologics License Application

BSUFA – Biosimilar User Fee Act

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)

GDUFA – Generic Drug User Fee Act

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

Pre-RFD – Pre-Request for Designation

RFD – Request for Designation

SE – Substantially Equivalent
1 FY 2017 OCP Performance Report

Introduction

On October 26, 2002, the Medical Device User Fee and Modernization Act (MDUFMA) was 

signed into law. 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 the OCP within the Office of the 

Commissioner. On December 13, 2016, the Cures Act was signed into law. Among other 

things, the Cures Act clarified and expanded the duties of OCP, to include ensuring the 

alignment of premarket review of combination products. Information about OCP, including the 

authorizing text of MDUFMA as amended by the Cures Act, can be found on the OCP Web site 

at www.fda.gov/CombinationProducts/default.htm. 

Description of Combination Products

Title 21 Code of Federal Regulations (CFR) § 3.2(e) states that combination products include:

(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 medical products (devices, drugs, and biological products) 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, applications of 

nanotechnology, and other innovative products and characteristics for diagnostic and 

therapeutic treatment of cardiovascular, neurological, metabolic, oncologic, and other disorders. 
2 FY 2017 OCP Performance Report

Statutorily Mandated Functions of OCP

MDUFMA and the Cures Act have established broad responsibilities for OCP that cover the 

regulatory life cycle from product jurisdiction decisions to duties relating to premarket review and 

postmarket oversight of combination products (i.e., drug-device, drug-biologic and devicebiologic combination products). However, the primary responsibilities for scientific premarket 

review and postmarket regulation of combination products remain in the three medical product 

Centers – CBER, CDER, or CDRH – to which they are assigned by OCP. 

Specifically, section 503(g)(8)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 

requires 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 reviews and the alignment of agency feedback to the sponsor and by 

coordinating 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 stakeholders and works with the relevant Centers to develop 

guidance documents, regulations, processes, and procedures to clarify and enhance the 

efficiency, consistency and transparency of combination products regulation.

In addition, OCP has responsibility for FDA action on all requests for designation (RFDs) 

submitted by industry in accordance with 21 CFR Part 3, “Product Jurisdiction.” RFDs may 

request classification of a particular product as a biological product, device, or drug, or 

combination product, a determination of its Center assignment or both.
3 FY 2017 OCP Performance Report

Performance Presented in This Report

This report presents FY 2017 OCP activities and accomplishments in assigning combination 

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

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

combination product applications. Accordingly, this section also provides FY 2017 performance 

information and updates FY 2016 performance information as related to timeliness in days of 

the reviews of combination products in the subsection “Timely and Effective Premarket 

Review.”3

Consistent with the mandated functions of OCP, information in this report 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, 2017.

 

3 FDA has initiated various activities related to implementation of the Cures Act requirements for combination 

products, and this report has been modified to provide new information to reflect the Cures Act requirements and 

expectations. As the Cures Act implementation proceeds, the Agency will consider what additional information or 

adjustments may be appropriate for subsequent reports. 
4 FY 2017 OCP Performance Report

Prompt Assignment of Combination Products

OCP is required to respond to RFDs to classify a particular product as a biological product, 

device, drug, or combination product and to assign a particular product to the appropriate 

Agency component. OCP assigns primary jurisdiction for combination products (i.e., Center 

assignment) based on the product’s primary mode of action (PMOA) (see 21 USC 353(g)(1), 21 

CFR 3.4(b)) in response to RFDs. RFD submissions are subject to a statutory 60-day 

deadline.4

 OCP also provides responses to Pre-RFD requests for assistance regarding product 

classification and assignment.5

Requirement Workload Trends: FY 2012 to FY 2017

The number of classifications and assignments in FY 2017 is compared to the previous 5-year 

averages for the total number of combination product and non-combination product 

classification and assignment determinations in the table below. While the number of 

classifications and assignments increased compared to FY 2016, it is lower compared to the 

respective 5-year averages. Specifically, as compared to the previous 5-year average, the total 

number of RFD combination product classifications and assignments was 50 percent lower in 

FY 2017 and non-combination classifications and assignments was 63 percent lower for FY 

2017. 

RFD Determinations 6

RFD Submissions FY 12 FY 13 FY 14 FY 15 FY 16 FY 17 

FY 12 to 

FY 16 

5-Year 

Average

FY 17 

Compared 

to 5-Year 

Average

Total RFD Combination 

Product Classifications/ 

Assignments 

23 17 8 2 2 5 10 - 50%

Total RFD Non-Combination 

Product Classifications/ 

Assignments

10 14 9 7 2 3 8 - 63%

 

4 OCP also provides assistance to sponsors regarding preparation of RFDs and development of data to support 

them, including in accordance with the Cures Act requirements codified at 21 USC 353(g)(1)(F). 5 Responses to Pre-RFD submissions for product classification and jurisdictional assignments do not have a required 

timeframe. However, OCP attempts to respond to Pre-RFD submissions in a timeframe similar to RFDs (i.e., within 

60 days). Information about Pre-RFD submissions (including the timeliness of OCP responses) is provided in section 

below titled Pre-RFD Workload Performance for FY 2017. 6 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 Workload Performance.
5 FY 2017 OCP Performance Report

The total number of RFD combination 

product classifications and assignments 

issued in FY 2017 increased by 3 as 

compared to FY 2016. 

The total number of RFD classifications and 

assignments for non-combination products 

increased in FY 2017 by 1 compared to FY 

2016.

FY 12 FY 13 FY 14 FY 15 FY 16 FY 17

Total 23 17 8 2 2 5

CBER 2 2 1 0 0 0

CDER 16 9 5 1 1 4

CDRH 5 6 2 1 1 1

0

5

10

15

20

25

30

35

40

Number of Requests

Combination Product Assignment Requests

FY 12 FY 13 FY 14 FY 15 FY 16 FY 17

Total 10 14 9 7 2 3

CBER 2 5 2 4 0 1

CDER 6 6 4 1 2 0

CDRH 2 3 3 2 0 2

0

5

10

15

20

Number of Requests

Non-Combination Product Assignment 

Requests
6 FY 2017 OCP Performance Report

OCP reviewed 61 RFD submissions in FY 2017.7 Of these submissions, decisions were issued 

for 8 submissions (13 percent), 49 RFD submissions were found by OCP to have insufficient 

information for filing (80 percent), and 4 submissions were withdrawn by the sponsor prior to 

filing or issuance of a decision (7 percent). 

In FY 2017, the 8 RFD determinations for combination (5) and non-combination (3) products, 

were all issued by the statutorily mandated 60-day deadline. The average and median 

combination product RFD review time was 58 days. The average non-combination product 

RFD review time was 57 days, with a median review time of 58 days. The following tables 

provide timeliness data by product type of the issued RFD decision. 

Timeliness of Combination Product 

Determinations

Determination

Product

Assignments

Issued* 

Percent

On Time*

Drug-Device 5 100%

Drug-Biologic 0 NA

Device-Biologic 0 NA

Drug-DeviceBiologic 0 NA

Total 5 100%

* 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 combination product in FY 2017.

Timeliness of Non-Combination Product 

Determinations 

Determination

Product

Assignments

Issued*

Percent

On Time*

Drug 0 NA

Biologic 1 100%

Device 2 100%

Total 3 100%

* 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 2017.

Pre-RFD Workload Performance 

In addition to RFDs, OCP also provided preliminary feedback/assessments in response to PreRFD submissions for product classification and jurisdictional assignment in FY 2017. The PreRFD process may be preferable to the more formal RFD process, such as 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), when a sponsor is 

contemplating whether to develop a specific product, or what configuration of that product to 

pursue. In the tables below, OCP Pre-RFD submission review workloads in FY 2017 are

provided. FY 2017 is the first full year of the “formalized” Pre-RFD program.8

 As such, 

available data allowing for a year-to-year comparison are not yet available. However, this yearto-year comparison data will be provided in future reports as it becomes available.

 

7 Of these 61 submissions, 59 submissions were received in 2017 and two submissions were carried over as pending 

at the end of FY 2016. Regarding the FY 2016 pending RFDs, 1 RFD resulted in a decision and 1 RFD was 

withdrawn by the sponsor prior to filing.

8 Formalization of the Pre-RFD program as a distinct OCP activity occurred during FY 2016. Consistent with past 

practice, Pre-RFD data presented in the FY 2016 report continued to be grouped with center-requested consultations 

(i.e., product classification and jurisdictional requests that originate with the FDA Centers and not with product 

sponsors). However, Pre-RFDs and Center requested consultations are two different types of interactions with OCP. 

Therefore, these two different data groups will be reported independently going forward. Center-requested 

consultations are discussed in the following section.
7 FY 2017 OCP Performance Report

In FY 2017, 78 Pre-RFD assessments were issued for combination (44) and non-combination 

(34) products, 96% by OCP’s internally established 60-day goal9 (see following tables). In FY 

2017, the 60-day review goal was missed for 3 submissions out of a total of 78. The average 

assignment review time was 37 days, with a median review time of 47 days. The following 

tables show Pre-RFD feedback for combination products and non-combination products based 

on classification and Center assignment.

OCP Pre-RFD Submission Workload

Pre-RFD Assessments FY 17 

Combination Product 

Assessments 44

Non-Combination Product 

Assessments 34

Total Pre-RFD Assessments 78 

Number of Combination Product Pre-RFD Assessments

Classification Assignments

Issued

Percent

Issued in 60 

Days

Drug-Device 35 100%

Drug-Biologic 1 100%

Device-Biologic 5 100%

Drug-DeviceBiologic 2 50%

Unclassified 1 100%

Total 44 98%

Number of Combination Product Pre-RFD Assessments by Center Assignment

Center 

Assignment

Consultations

Issued

CDER 32 

CBER 5 

CDRH 7 

Total 44 

 

9 OCP does not have a mandated review timeframe for Pre-RFD assessments. However, OCP attempts to review 

Pre-RFD assessments within the same timeframe as RFD submissions (i.e., 60 days).
8 FY 2017 OCP Performance Report

Number of Non-Combination Product Pre-RFD Assessments

Classification Assignments

Issued

Percent

Issued in 60 

Days

Drug 10 100%

Biologic 5 100%

Device 19 89% 

Total 34 94%

Number of Non-Combination Product Pre-RFD Assessments by Center Assignment

Center 

Assignment

Consultations

Issued

CDER 13

CBER 7 

CDRH 14

Total 34

OCP Performance on Internal Center-Requested Classification and 

Assignment Consultations 

In addition to RFDs and Pre-RFDs submitted by industry/sponsors, OCP also provided 

classification and assignment feedback for combination and non-combination products in 

response to requests from Centers in relation to premarket submissions. FDA review Centers 

may contact OCP for assistance in determining if the product submitted to a Center for review is 

appropriately assigned to that Center or whether the sponsor would need to be referred to OCP 

for a classification or assignment determination, or both. The number of such consultations 

provided by OCP is presented in the table below. As with the Pre-RFD data presented above, 

FDA intends to provide in future reports metrics for multiple fiscal years, as such data become 

available. 

Center-Requested Classification and Assignment Consultations

Center 

Assignment Consultations

CDER 29

CBER 3 

CDRH 16

Total 48
9 FY 2017 OCP Performance Report

Additional OCP Classification and Assignment Activities

This reporting category reports on all other activities not falling within the classification and 

assignment activities reported above. Examples of this category of activity include questions to 

OCP about process (e.g., how to prepare an RFD or Pre-RFD) and consultations from FDA 

Centers where OCP recommended sponsor referral to OCP for further discussion.

Additional Number of OCP Product Classification and Assignment Activities

FY 17

Jurisdiction/Classification Issues 528

OCP Requirements and Accomplishments

Type of Activity FY 2017 Accomplishments

Issuing required RFD assignments 

within 60 days

OCP issued all RFD assignments by the statutory 60-day 

determination deadline.

Clarifying standards for product 

classification and preparing guidance 

on this issue

OCP published a final guidance on the classification of drugs 

and devices and associated considerations, including for 

combination products. OCP also 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 for challenging categories 

of products, and continued to pursue and support related policy 

initiatives, including issuance of guidance on classification of 

human tissue products t, and to clarify standards for crosslabeled combination product status.

Enhancing the timeliness, 

consistency, and clarity of 

jurisdictional decisions across FDA

OCP continued to facilitate product classification and 

jurisdictional meetings with CBER, CDER, and CDRH and 

Counsel OCC staff, to exchange information and discuss 

challenging product classification and 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 assignment.

See also discussion of issuance of guidance on the Pre-RFD 

program and classification of products and other policy activities 

relating to product classification and assignment under Policy 

Activities and Accomplishments
10 FY 2017 OCP Performance Report

Combination Product Pre-Market Review 

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

combination products, including by overseeing the timeliness of reviews and the alignment of 

feedback by 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 biological products. 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 Web site at 

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

10

In FY 2017, in light of feedback from stakeholders and internal FDA staff regarding the 

consistency, efficiency, and coordination within FDA of premarket reviews for combination 

products, FDA piloted a revised inter-center consultative process to ensure consultation occurs 

as appropriate, improve early identification of the inter-center review team, enhance efficiency of 

consult request issuance and clarity of questions asked, and better ensure responsiveness and 

documentation of completed consults. Based on the results of this pilot, an updated process is 

expected to be implemented and incorporated into the FDA Staff Manual Guide by early FY 

2018.

Number and Types of Combination Products Submitted for Review

FDA is required to report the number and types of combination products submitted for review. 

The following information refers to FDA performance data presented in this subsection.

• Data on the number and types of combination products submitted for review for FY 2017 by 

CBER, CDER, and CDRH include submissions filed or received in FY 2017. 

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

products, The prescription Drug User Fee Act (PDUFA V) goals were referenced for priority 

and standard new drug applications (NDAs) and applicable biologics license applications 

(BLAs), the Generic Drug User Fee Act (GDUFA) goals were referenced for 2017 goals for 

abbreviated new drug applications (ANDAs), and Biosimilar User Fee Act (BsUFA) goals 

were referenced for 2017 goals for BLAs for biosimilar combination products. For CBER-led 

or CDRH-led combination products, MDUFA III goals were referenced for expedited and 

original premarket approval applications (PMAs), premarket notifications [510(k)s], and 

device BLAs.

• 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).

 

10 In FY 2017, the inter-center consultation process is undergoing a review and testing enhancements. Additional 

information regarding these changes is available on pages 17 and 18 of the report.
11 FY 2017 OCP Performance Report

• Median review time was based on FDA first cycle review performance for PDUFA V goals. 

For MDUFA III goals, median review times were based on total MDUFA III decision review 

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

Requirement Workload Trends: FY 2012 to FY 2017

Beginning with FY 2017, FDA is now reporting on workload for abbreviated new drug 

applications (ANDAs) and de novo classifications (de novos) submissions in addition to the 

previous application types reported upon in prior OCP Reports to Congress. FDA is also 

tracking user fee performance for biosimilar products separately from other biological products. 

FDA is making these changes in light of submission trends and clarification provided by Cures 

with respect to premarket availability of premarket pathways for combination products.

FY 2017 Submission Review Workloads

Submission/Request FY 12 FY 13 FY 14 FY 15 FY 16* FY 1711

Total Combination Products 

Submitted for Review by 

Centers

264 313 317 341 330 561

* FY 2016 numbers were changed to reflect updates to data presented in the FY 2016 OCP Performance Report.

The total number of combination products submitted for review increased in FY 2017. Sixtyseven percent (67%) of the combination product submissions received were led by CDER, 

followed by CDRH (24 percent) and CBER (9 percent).

 

11 Reported FY 2017 data include additional submission types (i.e., ANDAs and de novo submissions) that were not 

previously reported in past years. As such the data shown for FY 2017 are not directly comparable to the past years 

shown in this table. 

FY

12

FY

13

FY

14

FY

15

FY

16

FY

17

Total 264 313 317 341 330 561

CBER 38 37 44 37 36 53

CDER 117 136 147 175 199 375

CDRH 109 140 126 129 95 133

0

100

200

300

400

500

600

Number of Submissions

Combination Product Application 

Submissions
12 FY 2017 OCP Performance Report

The table below presents the 561 original applications for combination products received in FY 

2017, broken down by the identified ten application types and by the product’s initial 

classification into one of nine categories of combination product.12 The same table reflecting 

applications received in FY 2016 is updated in Appendix A to reflect corrections and actions as 

of September 30, 2017. The majority of the applications (53 percent) received in FY 2017 were 

Original INDs, followed by Original 510(k)s (16 percent) and ANDAs (12 percent). The most 

common combination product category was pre-filled drug delivery device/system (19 percent), 

followed by device coated/impregnated/otherwise combined with drug (18 percent).

Workload by Combination Product Category Number

Application 

Type 1 2 3 4 5 6 7 8 9 Totals

Original NDAs 7 23 0 2 0 0 0 0 2 34

Original BLAs 0 0 8 0 0 1 0 0 0 9

Original PMAs 0 0 0 5 1 0 1 0 2 9

Original 

510(k)s 6 0 2 56 3 0 7 3 12 89

Original INDs 33 46 23 12 14 66 0 92 11 297

Original IDEs 6 0 0 27 0 0 4 3 7 47

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

ANDAs 27 40 0 0 0 0 0 0 1 68

Biosimilars 6 0 1 0 0 0 0 0 0 7

De novos 1 0 0 0 0 0 0 0 0 1

Totals 85 109 34 102 18 67 12 98 35 561

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

 

12The 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). 
13 FY 2017 OCP Performance Report

Inter-center Consultation Requests

The total number of inter-center consult requests increased for FY 2017 to the highest number 

in the past 6 years. The number of inter-center consults increased by 55% as compared to the 

previous 5-year average. 

Total review workload for inter-center consults in FY 2017 is compared to the previous 5-year 

averages in the table below.

FY 2017 Inter-center Consult Workloads

Submission/Request FY 12 FY 13 FY 14 FY 15 FY 16* FY 17

FY 12 to 

FY 16

5-Year 

Average

FY 17 

Compared 

to 5-Year 

Average

Total Inter-center Consult 

Requests 660 828 1,013 932 1,130 1,419 913 + 55%

FY

12

FY

13

FY

14

FY

15

FY

16

FY

17

Total 660 828 1,013 932 1,130 1,419

CBER 40 31 48 53 9 105

CDER 350 506 643 499 793 881

CDRH 270 291 322 380 328 433

0

100

200

300

400

500

600

700

800

900

1000

1100

1200

Number of Requests

Inter-center Consultation Requests by 

Reviewing Center
14 FY 2017 OCP Performance Report

The table below presents the number of inter-center consult requests during FY 2017, broken 

down by requesting Center (i.e., primary assigned lead Center) and which Center reviewed the 

consult (i.e., consulting center).13 

Number of Premarket Review Inter-center Consults for Combination Products by Requesting and 

Assigned Center

Requesting 

Center

Reviewing Center

CBER CDER CDRH Number of 

Consults

CBER -- 10 6 16

CDER 30 -- 427 457

CDRH 75 871 -- 946

Total 105 881 433 1,419

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 New Drug 

Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Prescription Drug User Fee 

Act (PDUFA) Biologics License Applications (BLAs), Biosimilar User Fee Act (BsUFA) BLAs, 

Premarket Approval Applications (PMAs), Device Classification under Section 513(f)(2) of 

FD&C Act (De Novos), and Premarket Notifications (510(k)s). PDUFA V, Generic Drug User 

Fee Act (GDUFA), BsUFA, and Medical Device User Fee Amendments (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 timeframe. Typical goals range from 50 percent 

to 90 percent and vary by year. 

For MDUFA III performance goals, refer to 

www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf

For PDUFA V performance goals, refer to 

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

 

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

requests are associated with any combination product under review, 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 2017 (reported in the previous section).
15 FY 2017 OCP Performance Report

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 Standard with no Advisory 

Committee Input 180 days

MDUFA III Expedited and Original PMAs Standard with Advisory 

Committee Input 320 days

MDUFA III 510(k)s Standard 90 days

MDUFA III BLAs Priority 6 months

MDUFA III BLAs Standard 10 months

BsUFA Biosimilars Standard 10 months

GDUFA I ANDAs Standard 10 months

MDUFA III De Novos Standard N/A

† 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). 

FDA premarket review performance information 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 2016 

combination product submissions and presents FDA’s review performance on the FY 2017 

combination product submissions through September 30, 2017.
16 FY 2017 OCP Performance Report

FY 2016 and FY 2017 Review Performance

Final FY 2016 review goal performance is presented in the table below and were similar 

between FY 2016 and FY 2017. 

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 3 183 165 to 336

NDAs Standard 10 months 16 304 301 to 394

BLAs Priority 6 months 2 289 242 to 335

BLAs Standard 10 months 6* 351 301 to 457

Expedited and 

Original PMAs Standard 180 or 320 days† 2* 177 177

510(k)s Standard 90 days 67* 87 9 to 161

* FY 2016 numbers were changed to reflect updates to data presented in the FY 2016 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 2017 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 4 184 182 to 184

NDAs Standard 10 months 30* 304 276 to 365

BLAs Priority 6 months 4* 240 239 to 240

BLAs Standard 10 months 5* 363 363

Expedited and 

Original PMAs Standard 180 or 320 days† 9* 179 170 to 180

510(k)s Standard 90 days 78* 81 15 to 220

Biosimilars Standard 10 months 7* 302 302

ANDAs Standard 10 months 67* 301 267 to 316

De Novos Standard N/A‡ 1 126 126

* Included in this count are NDAs, ANDAs, BLAs, PMAs 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 reported 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. 

‡ De Novo applications did not have an associated performance goal in FY17.
17 FY 2017 OCP Performance Report

Premarket Review 

OCP continued to facilitate the premarket review of combination products that raised complex 

regulatory issues. OCP fosters early interactions between industry and FDA to develop clearly 

delineated regulatory pathways for the development of combination products and expeditious 

review of premarket submissions for these products. Responding to requests from both industry 

and FDA review staff, OCP provides guidance on regulatory challenges unique to combination 

products. OCP also serves as a resource for FDA staff on the appropriate use and 

interpretation of combination product categorization for premarket submissions and assists staff 

in CBER, CDER, and CDRH in determining the correct combination product categories for data 

reporting purposes. Finally, OCP leads or participates in meetings and discussions, and 

otherwise engages, to ensure efficient, effective communication between sponsors and FDA 

review staff. OCP FY 2017 accomplishments related to premarket review are included in the 

tables below.

Number of OCP Documented Premarket Activities

FY 12 FY 13 FY 14 FY 15 FY 16 FY 17

FY 12 to 

FY 16

5-Year 

Average

FY 17 

Compared 

to 5-Year 

Average

Premarket Review 

Issues 120 157 402 225 266 525 234 + 124%

OCP received 525 requests for product-specific assistance, the responses to which contributed 

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

issues related to novel drug and biological product delivery systems, emergency use products, 

generic products that include devices, alignment of preclinical and biocompatibility data 

requests, approvability of rare disease products, alignment of review assessments for drugpump delivery and drug-device implant products, consistency and clarity of labeling, and 

developmental considerations for combination products with mobile communication 

technologies.

OCP oversees inter-center consults and facilitates inter-center coordination and Agency 

coordination with sponsors, to ensure that reviews of premarket applications are coordinated as 

appropriate, completed in a timely manner and meet PDUFA V, GDUFA I, BsUFA I, 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; resolves other barriers to timely completion of consults. 

In addition, OCP provided assistance to the Centers in resolving regulatory and scientific issues 

relating to specific combination products or to specific categories of combination products. OCP 

also responds to industry inquiries. For example, OCP responded to external industry requests 

to host cross-center early development meetings on bundled issues to minimize redundant 

product meetings. 
18 FY 2017 OCP Performance Report

Type of Activity FY 2017 Accomplishments

Providing Significant 

Premarket Review 

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 conditions of use

• Medical imaging drugs with device delivery systems and imaging 

systems

• Coordination of premarket CGMP inspections 

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

• Inter-center manufacturing process compliance and safety evaluator 

processes 

• Registration and listing and associated information technology 

infrastructure 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 for a 

combination product

• Unique device identifiers and standardized numerical identification

• Alignment of IND and IDE requirements for combination products

• Coordination of cross-center safety signal assessments

Combination Product Postmarket Activities 

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

combination products, and FDA is required to describe any improvements in the consistency of 

postmarket regulation of combination products. 

OCP meets the requirement to ensure consistency and appropriateness by undertaking a 

variety of compliance-related 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 (as discussed more fully in Policy Activities and 

Accomplishments below), 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 on CGMP facility inspection issues and on seizure of 

products at ports of entry to stop illegal products from entering the United States; responding to 

product defect issues; providing assistance on enforcement issues relating to import 

requirements and assisting in the development of compliance and enforcement action 

communications such as warning letters. OCP FY 2017 accomplishments related to the 

consistency and appropriateness of postmarket regulation are included in the table below (see 

also Policy Activities and Accomplishments below). 
19 FY 2017 OCP Performance Report

Documented Product-Specific Postmarket Regulatory Activities

FY 12 FY 13 FY 14 FY 15 FY 16 FY 17

FY 12 to 

FY 16

5-Year 

Average

FY 17 

Compared 

to 5-Year 

Average

Postmarket Regulatory

Activities 33 57 110 71 50 74 64 +16%

OCP addressed 74 postmarket-related matters involving such issues as the application of 

CGMPs and quality system regulations for inspections of combination products, appropriate 

mechanisms and responsibilities for reporting adverse events, and requirements for registration

and listing. This represents a 16% increase in the number of issues compared to the prior 5-

year average.

These efforts have helped improve the consistency of postmarket regulation in a number of 

ways, including by:

- Enhancing coordination among Agency components in support of CGMP inspectional 

and compliance policies and practices

- Clarifying stakeholder and FDA understanding of CGMP obligations (see also

publication of a final guidance discussed under Policy Activities and Accomplishments 

below) 

- Clarifying stakeholder and FDA understanding of PMSR requirements (see also

publication of a final rule discussed under Policy Activities and Accomplishments below) 
20 FY 2017 OCP Performance Report

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).

Percentage of Combination Products for which a Dispute Resolution 

was Requested 

FDA is required to identify the percentage of combination products for which a dispute 

resolution, with respect to premarket review, was requested by the combination product’s 

sponsor.14 For FY 2017, the percentage is zero. The “Timely and Effective Premarket Review” 

section of this report provides examples of informal facilitation and resolution of issues related to 

premarket review.

 

14 This reporting requirement was established by the Cures Act and replaces the prior requirement to report on the 

timeliness in days of dispute resolutions regarding combination products.
21 FY 2017 OCP Performance Report

Policy Activities and Accomplishments

Regulatory Initiatives

OCP activities include leading and assisting with policy initiatives important to and affecting the 

regulation of combination products. Examples of such activities pursued in FY 2017 are 

discussed below and included in the following tables.

Supporting legislative initiatives

OCP participated in development of FDA positions and engagement with Congress and 

stakeholders regarding legislative initiatives and briefings on combination products and 

combined use of medical products, including:

• The Cures Act and

• Fostering Innovation in Medical Imaging Act of 2017

Streamlining regulation

OCP published a final rule on PMSR for combination products to clarify and streamline PMSR 

requirements for combination products subject to premarket review.

OCP initiated revisions to FDA’s jurisdiction regulations at 21 CFR Part 3, to update and clarify 

them in light of legislative and other policy developments.

Providing clarifying guidance

OCP published with the medical product Centers:

• Final guidance on current good manufacturing requirements for combination products15

• Final guidance on classification of products as drugs and devices and additional 

classification issues16

• Draft guidance on the Pre-RFD Program17

 

15 Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm. 16 Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.htm. 17 Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm534661.htm. 
22 FY 2017 OCP Performance Report

Additional Jurisdictional Regulatory Initiatives

Type of Activity FY 2017 Accomplishments

Developing regulations

Additional OCP jurisdiction-related activities included 

participating in the following Agency rulemaking and guidance 

initiatives: 

• Rulemaking on the regulatory status of wound care 

products 

• Rulemaking on the meaning of “protein” in the definition of 

“biological product” in the Public Health Services Act

Participation in other inter-center and 

Agency-wide working groups to clarify 

issues related to product jurisdiction

OCP jurisdiction-related activities included participating in the 

following Agency rulemaking and guidance initiatives:

• Enhancing the efficiency and transparency of the Pre-RFD 

Program

• Classification-related issues for e-cigarettes and products 

that include tobacco, drugs, and devices

Additional Premarket Review Regulatory Initiatives

Type of Activity FY 2017 Accomplishments

Developing guidance and regulations

• OCP chaired a cross center working group to finalize 

guidance on human factors studies for combination products

• OCP chaired a cross-center working group to begin 

development of draft guidance for technical aspects of 

intravaginal ring drug-delivery combination products

OCP participated in the development of: 

• rulemaking on De Novo classification 

• rulemaking on use of symbols in device and device-led 

combination product labeling

• Guidance on pre-submission facility inspection for generic 

drugs

• Guidance on metered dose inhalers and dry powder inhalers

• Guidance on flow restrictors

• Guidance and citizen petition responses for specific types of 

generic combination products

• Guidance on comparative assessments, including human 

factors for generic drug-led and interchangeable biologic-led 

combination products

• Selection of appropriate package type terms and 

recommendations for labeling injectable medical products 

• Where to provide device constituent part information when 

using the CDER/CBER Electronic Common Technical 

Document (eCTD) format

• Technical considerations for visual inspection for particulates 

in injectable solutions

• Final guidance on classification of human tissue products

• Comments on ISO standards development for certain 

syringes
23 FY 2017 OCP Performance Report

Type of Activity FY 2017 Accomplishments

Developing possible regulatory 

pathways for new products intended 

to be used with another sponsor’s 

already-approved 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 preparations for a Part 

15 hearing

Participation in other inter-center and 

Agency-wide working groups to 

clarify issues related to combination 

products

OCP led or participated in working groups with Centers and other 

Agency components regarding:

• The appropriate regulatory pathway for novel technology 

diagnostics and biomarkers for use with drug or biological 

products

• Companion diagnostics

• Expanding non-prescription drug availability

• Development of Agency thinking on regulation of software as 

drug labeling Agency-wide working groups such as FDA’s 

Task Force on Antimicrobial Resistance

Consultative/Collaborative Review 

Process and Procedures 

Development

OCP along with other components of the Office of the 

Commissioner and with the medical product Centers continued 

an inter-center consult process pilot intended to enable timely 

and consistent coordination to enable efficient, consistent review 

of submissions. This activity included development and 

presentation of training materials; facilitating, monitoring and 

assessing consult activities

Additional Postmarket Review Regulatory Initiatives

Type of Activity FY 2017 Accomplishments

Participation in other intercenter and Agency-wide 

working groups to clarify 

issues related to 

combination products and 

guidance development

• OCP continued to chair working groups relating to PMSR for 

combination products, focused on development of a draft 

guidance regarding the final rule and other efforts to implement 

the rule including development of internal SOPs 

• OCP 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, which was 

published by AAMI in 2017, and that began work on a TIR on 

risk management for combination products. 

• OCP continued to chair a working group and leadership body to 

support implementation of the final rule on CGMPs for 

combination products, including inspectional activities and 

expectations relating to premarket submissions

• OCP continued to work with Centers on track and trace regimes 

with respect to combination products, including Unique Device 

Identifier, numeric drug coding and serialized numeric identifiers
24 FY 2017 OCP Performance Report

Additional Activities and Accomplishments

Information Technology

OCP continued to coordinate and participate in cross-cutting information technology initiatives, 

to enhance infrastructure and update guidance as appropriate to improve the efficiency, 

consistency and reliability of information systems and communications within and among 

medical product Centers and between FDA and combination product sponsors and other 

interested stakeholders. OCP led efforts to improve staff access to IT systems needed for the 

review of combination products, and to update PMSR Agency IT systems and develop new 

guidance on how stakeholders should engage with them, in light of the final rule on PMSR for 

combination products.

External Outreach

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

combination products by meeting with trade associations and coalitions (e.g., Combination 

Products Coalition, Advanced Medical Technology Association, Association for Advancement of 

Medical Instrumentation) representing the drug, device, biological product, and combination 

product industries, and participating in industry conferences. 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, specific categories of 

combination products, particular regulatory issues, and stakeholder priorities for further action. 

Examples of FY 2017 outreach activities are included in the table below.

Type of Activity FY 2017 Accomplishments

Presentations and outreach 

activities

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

examples of 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 

• 2017 Drug Information Association Annual Conference on Combination 

Products

• Parenteral Drug Association/FDA Joint Regulatory Conference

• Drug Information Association Annual Meeting 2017

• FDLI 2017 Annual Conference

• Xavier University Health Combination Products Summit (September 

2017)
25 FY 2017 OCP Performance Report

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26 FY 2017 OCP Performance Report

Appendix

Appendix A: FY 2016 Updated Performance Detail

The table below reflects the 331 original applications initially classified into one of nine 

categories of combination products received in FY 2016. 

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 2016 by 

Center lead, as of September 30, 2017. 

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

Original NDAs 5 12 0 1 0 0 0 0 1 19

Original BLAs 1 0 6 0 1 0 0 0 0 8

Original PMAs 0 0 0 2 0 0 0 0 0 2

Original 510(k)s 10 0 0 51 1 0 5 1 3 71

Original INDs 5 50 10 11 1 40 1 79 4 201

Original IDEs 3 0 0 11 4 0 1 5 5 29

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

Totals 24 62 16 76 7 40 7 85 13 330

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.