Guidance for Industry and FDA Staff 

Expedited Review of Premarket 

Submissions for Devices 

Document Issued on: February 29, 2008 

This document supersedes “Expedited Review of Premarket Submissions for 

Devices” dated November 26, 2003.

For questions regarding the use or interpretation of this guidance in the review of PMAs and 

PDPs, please contact the PMA Staff at (240) 276-4040. 

For questions regarding the use or interpretation of this guidance in the review of 510(k)s, 

including the Evaluation of Automatic Class III Designation classification actions (de novo 

review), please contact Heather Rosecrans at (240) 276-4021 or by email at 

heather.rosecrans@fda.hhs.gov. 

For questions regarding the use or interpretation of this guidance in the review of devices 

regulated by CBER, please contact Sayah Nedjar, Ph.D., at 301-827-3524 or by email at 

sayah.nedjar@fda.hhs.gov. U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Devices and Radiological Health 

Center for Biologics Evaluation and Research
Preface 

Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the 

Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 

1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted 

to http://www.Regulations.gov. When submitting comments, please refer to the exact title of this 

guidance document. Comments may not be acted upon by the Agency until the document is next 

revised or updated. 

Additional Copies 

Additional copies are available from the Center for Devices and Radiological Health (CDRH) 

through the Internet at: http://www.fda.gov/cdrh/mdufma/guidance/108.pdf or 

http://www.fda.gov/cdrh/mdufma/guidance/. You may also send an e-mail request to 

dsmica@fda.hhs.gov to receive an electronic copy of the guidance document or send a fax 

request to 240-276-3151 to receive a hard copy. Please use the document number (108) to 

identify the guidance document you are requesting. 

Additional copies of this guidance document are also available from the Center for Biologics 

Evaluation and Research (CBER), Office of Communication, Training and Manufacturers 

Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by 

calling 1-800-835-4709 or 301-827-1800, or from the Internet at 

http://www.fda.gov/cber/guidelines.htm. 
Contains Nonbinding Recommendations 

Table of Contents 

I. Introduction ............................................................................................................................. 1 

II. Devices Appropriate for Expedited Review............................................................................ 3 

III. Special Considerations............................................................................................................ 3 

IV. Expedited Review: Its Meaning and Impact .......................................................................... 4 

V. Expedited Review Queue ........................................................................................................ 4 

VI. Applicability to PMA Performance Goals .............................................................................. 5 

VII. Requesting Expedited Review................................................................................................. 6 

A. Industry Responsibilities.................................................................................................6 

B. FDA Responsibilities.......................................................................................................7 

C. FDA Timeframes for Determinations..............................................................................7 

D. FDA Administrative Procedures .....................................................................................8 

VIII. Expedited Review Procedures for FDA.............................................................................. 8 

A. Resource Management ....................................................................................................9 

B. Advisory Panel Review ...................................................................................................9 

C. Monitoring.......................................................................................................................9 

D. Public Disclosure.............................................................................................................9 

Attachment 1: Suggested Timeframes for Discussing Expedited Review with FDA ................. 11 

Attachment 2: Expedited Review Form....................................................................................... 12 
Contains Nonbinding Recommendations 

Guidance for Industry and FDA Staff 

Expedited Review of Premarket Submissions 

for Devices 

This guidance document represents the Food and Drug Administration's (FDA's) current 

thinking on this topic. It does not create or confer any rights for or on any person and does 

not operate to bind FDA or the public. You can use an alternative approach if the approach 

satisfies the requirements of the applicable statutes and regulations. If you want to discuss an 

alternative approach, contact the FDA staff responsible for implementing this guidance 

document. If you cannot identify the appropriate FDA staff, call the appropriate number 

listed on the title page of this guidance document. 

I. Introduction 

This document has the following purposes: (1) develop a common understanding of the statutory 

criteria for granting expedited review to premarket submissions for medical devices, and (2) 

outline standard procedures that should be followed to achieve an efficient expedited review 

process. Furthermore, this updated version of the guidance document reflects the changes under 

the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85)1

and corresponding changes in our expedited review policy for premarket approval applications 

(PMAs),2

 premarket reports,3 product development protocols (PDPs), and premarket notification 

submissions (510(k)s). 

An expedited review process for medical devices was first developed in 1994 and explained in a 

General Program Memorandum (G94-2) entitled, “PMA/510(k) Expedited Review.” That 

document was revised and issued as a guidance document on March 20, 1998, to reflect the 

expedited review criteria in Section 515(d)(5) of the Federal Food, Drug, and Cosmetic Act (the 

Act).4

 The revised guidance document, known as “PMA/510(k) Expedited Review – 

Guidance for Industry and CDRH Staff,” was superseded and replaced by the guidance 

document entitled, “Expedited Review of Premarket Submissions of Devices,” dated 

November 26, 2003, which reflected a decade of experience from administering an expedited 

 

1

 FDAAA includes the Medical Device User Fee Amendments of 2007 (MDUFMA II). 

2

 PMAs involved are traditional PMAs, modular PMAs (after the last module is received), and panel-track 

supplements. 

3

 A premarket report is a PMA application for a reprocessed, single-use device (see section 515(c)(2) of 

the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360e(c)(2)). 

4

 While Section 515(d)(5) of the Act only applies to premarket approval applications (PMAs), because of 

the potential public health importance of devices warranting expedited review status, FDA also has 

applied the expedited review criteria to all premarket submissions, including devices evaluated under a 

PDP, the Evaluation of Automatic Class III Designation process (also known as the “de novo” or “risk 

based” classification process),4

 and 510(k)s. For information on the de novo process, refer to Section 

513(f)(2) of the Act and the guidance document entitled “Evaluation of Automatic Class III Designation” 

found at http://www.fda.gov/cdrh/modact/classiii.html. 

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review program for medical devices, as well as the performance goals set forth in the MDUFMA 

I Goals Letter. 5 

The 2003 version of this guidance document is superseded by this version, which incorporates 

changes under FDAAA. More specifically, for PMAs, FDA will no longer require additional 

conditions in order for an expedited PMA to be measured against MDUFMA expedited 

performance goals. Therefore, this guidance document no longer includes information specific 

to the additional conditions described under MDUFMA I for expedited PMAs.6 In addition, if a 

PMA or 510(k) is granted expedited status, this status would not be revoked during its review 

should a device of the same type be approved or cleared. 

FDA's guidance documents, including this guidance document, do not establish legally 

enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking 

on a topic and should be viewed only as recommendations, unless specific regulatory or statutory 

requirements are cited. The use of the word should in Agency guidance documents means that 

something is suggested or recommended, but not required. 

The Least Burdensome Approach 

We believe we should consider the least burdensome approach in all areas of medical device 

regulation. This guidance reflects our careful review of the relevant scientific and legal 

requirements regarding premarket device submissions and what we believe is the least 

burdensome way for you to comply with those requirements. However, if you believe that an 

alternative approach would be less burdensome, please contact us so we can consider your point 

of view. You may send your written comments to the contact person listed in the preface to this 

guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, 

including contact information, can be found on the Internet at 

http://www.fda.gov/cdrh/ombudsman/. 

 

5

 For more information, please refer to the letter from the Secretary of Health and Human Services to the 

Committee on Energy and Commerce of the House of Representatives and the Committee on Health, 

Education, Labor, and Pensions of the Senate (“Goals Letter”) dated November 19, 2002, 

http://www.fda.gov/cdrh/mdufma/pgoals.html and referenced in section 101(3) of the Medical Device 

User Fee and Modernization Act of 2002 (MDUFMA I). 

6

 A pre-filing meeting was one of the previous conditions under MDUFMA I for a PMA to have an 

expedited review status and be subject to MDUFMA performance goals. Although removed as a 

condition, CDRH intends to develop guidance on meetings with industry, including pre-submission 

meetings. For CBER submissions, please refer to CBER’s meeting procedures webpage at 

http://www.fda.gov/cber/regsopp/81011.htm. 

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II. Devices Appropriate for Expedited Review 

FDA considers a device, or combination product containing a device,7 appropriate for expedited 

review8 if the device or combination product: 

1. is intended to treat or diagnose a life-threatening or irreversibly debilitating 

disease or condition, and

2. addresses an unmet medical need, as demonstrated by one of the following:

 a. The device represents a breakthrough technology that provides a clinically 

meaningful advantage over existing technology. Breakthrough technologies 

should be demonstrated to lead to a clinical improvement in the treatment or 

diagnosis of the life-threatening or irreversibly debilitating condition. 

 b. No approved alternative treatment or means of diagnosis exists. 

 c. The device offers significant, clinically meaningful advantages over existing 

approved alternative treatments. The device should provide for a clinically 

important earlier or more accurate diagnosis or offer important therapeutic 

advantages in safety and/or effectiveness over existing alternatives. Such 

advantages may include demonstrated superiority over current treatments for 

effects on serious outcomes (e.g., morbidity), ability to provide clinical benefit for 

those patients unable to tolerate current treatments, or ability to provide a clinical 

benefit without the serious side effects associated with current treatments. 

d. The availability of the device is in the best interest of patients. That is, the 

device provides a specific public health benefit, or meets the need of a welldefined patient population. This may also apply to a device that was designed or 

modified to address an unanticipated serious failure occurring in a critical 

component of an approved device for which there are no alternatives, or for which 

alternative treatment would entail substantial risk of morbidity for the patient. 

III. Special Considerations 

Manufacturers who are working with a federal agency in the development of medical devices to 

address a national security issue should include a letter in the premarket submission from the 

federal agency (e.g., Department of Defense, Department of Homeland Security) identifying the 

specific device or device type and indicating that commercial availability is of particular 

importance to our national security. The letter should be printed on official agency letterhead 

and signed by an individual with appropriate authority for making the request. 

 

7

 Combination products are eligible for expedited review under the MDUFMA goals when CDRH or 

CBER has been designated as the lead Center. 

8

 FDA is required by statute, section 515(d)(5), to review only PMAs meeting certain conditions on an 

expedited basis. FDA, however, is using these criteria as guidelines for expedited review of PDPs, 

510(k)s, and de novo classifications. For more information on de novo classification, refer to 

http://www.fda.gov/cdrh/devadvice/314c.html. 

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To expedite the process, the letter should also be faxed to the Office of Device Evaluation’s 

Program Operation Staff (POS). The early fax to POS will allow for confirmation of the 

expedited status and will allow for better monitoring of the review status of the expedited 

submission. 

IV. Expedited Review: Its Meaning and Impact 

While all device submissions granted expedited review status are subject to priority review, there 

is no assurance that a device will receive FDA marketing authorization in a more timely manner 

when compared with submissions not granted expedited status. The reasons for this outcome are 

varied, such as a device involves new technology or presents complex scientific and regulatory 

issues that warrant more in-depth review; a failure by the manufacturing facility to be prepared 

for inspection; or a failure of the applicant to provide adequate scientific data in its submission. 

In order to reap a benefit from the expedited review process, the commitment on behalf of the 

applicant to resolve all scientific and regulatory issues should match that of FDA. It will only be 

through effective communication (i.e., interactive review) and a total commitment to fulfilling all 

regulatory and scientific requirements that FDA and the applicant can speed market authorization 

for safe and effective products.9

Although an expedited PMA will be assessed against the MDUFMA II expedited performance 

goals without a pre-filing meeting, FDA strongly recommends to industry to have such a 

meeting.10

V. Expedited Review Queue 

Granting expedited review status means that a marketing application that is determined to be 

appropriate for expedited review is placed at the beginning of the appropriate review queue and 

receives additional review resources, as needed. If multiple applications for the same type of 

device offering comparable advantage over existing approved alternatives have been granted 

expedited review, they are reviewed with priority assigned on a first-in-first-reviewed (FIFR) 

basis for each review cycle. 

Furthermore, if one of these applications is approved, the remaining expedited applications will 

retain their expedited status until a final decision is rendered. This is a change from our previous 

practice in which we would revoke the expedited status from all pending expedited submissions 

once we approve a submission of the same type. We are implementing this change in order to 

simplify our review process. Since MDUFMA provides different performance goals for nonexpedited and expedited PMAs, switching the status during the review of an application requires 

the review staff to switch to a different review process and be accountable for meeting a different 

9

 FDA has issued a guidance document on interactive review entitled, “Guidance for Industry and FDA 

Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, 

Original BLAs, and BLA Supplements,” http://www.fda.gov/cdrh/ode/guidance/1655.html. 10 CDRH intends to develop guidance on meetings with industry, including pre-submission meetings. For 

CBER submissions, please refer to CBER’s meeting procedures webpage at 

http://www.fda.gov/cber/regsopp/81011.htm. 

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Contains Nonbinding Recommendations 

goal. For this reason, the status of the application should be decided at the time the submission is 

filed and will continue until the review is completed and a final decision is rendered. 

Any new application filed after the approval or clearance of a device of the same type will not be 

given an expedited status unless covered under Section III (Special Considerations). 

VI. Applicability to PMA Performance Goals 

Under MDUFMA I, for a traditional PMA, modular PMA, or panel-track supplement to be 

tracked against the expedited PMA performance goals, the applications/supplement had to meet 

the statutory expedited criteria described in Section II (Devices Appropriate for Expedited 

Review) AND the PMA applicant had to meet the following conditions: 

• the applicant attended a pre-filing meeting with FDA; 

• the PMA was substantively complete as defined at the pre-filing meeting; and 

• the manufacturing facilities were prepared for a good manufacturing practice (GMP) 

inspection at the time of the PMA submission. 

If a PMA met the expedited statutory criteria but did not satisfy all three of the conditions above, 

the application was still considered expedited and FDA prioritized review of the application. 

However, FDA was not obligated to meet the MDUFMA I expedited PMA performance goals 

for this application. Thus, there were actually two different categories for expedited review: a 

“statutory only” category and a “statutory and MDUFMA” category. 

Having two different expedited categories led to implementation difficulties, such as how to 

determine whether a device manufacturing site was ready for inspection at the time a PMA was 

submitted. While a PMA applicant may have claimed in its PMA submission that its 

manufacturing site was ready to be inspected, FDA’s inspectors often discovered that sites were 

actually not ready for inspection. Likewise, there were no criteria for deciding whether or not a 

particular meeting that an applicant had with the FDA, regardless of the topic of discussion, 

constituted a pre-filing meeting. 

Thus, because of the difficulty in implementing the expedited provision under MDUFMA I, 

FDA and the industry agreed to streamline the process and eliminate the three additional 

conditions above. Therefore, under FDAAA, FDA will now evaluate the expedited status of 

each PMA application based solely on the original statutory criteria defined in Section II 

(Devices Appropriate for Expedited Review) above. Furthermore, all expedited original PMAs 

and panel track supplements will be assessed against the MDUFMA II expedited performance 

goals.11

 

11 See the guidance document entitled, “FDA and Industry Actions of Premarket Approval Applications 

(PMAs): Effect on FDA Review Clock and Performance Assessment,” at 

www.fda.gov/cdrh/mdufma/guidance/1218.html. 

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VII. Requesting Expedited Review 

The responsibility for identifying devices that are appropriate for expedited review is a 

responsibility jointly shared by industry and FDA. A primary objective of this guidance 

document is to promote a common understanding of which device submissions may be granted 

expedited review status to facilitate an early recognition of devices that merit such review. 

(Refer to Attachment 1 for suggested timeframes for making expedited review determinations 

early in the device development process.) 

A. Industry Responsibilities 

Opportunities to identify a device as a candidate for expedited review occur throughout the 

device development process. Some of the factors described earlier in this guidance document 

that indicate that a device should be granted expedited review status may be apparent during the 

early stage of development, while other factors that indicate a device should be granted 

expedited review status may not be apparent until there has been an actual assessment of patient 

outcomes. As an example, a device in the early design stage may qualify for expedited review if, 

for a certain life-threatening disease or condition, there exists no approved alternative treatment 

(i.e., see conditions 1 and 2b in Section II (Devices Appropriate for Expedited Review) of this 

guidance document). Alternatively, a device further along in the development process that has 

undergone clinical testing may be eligible for expedited review based on significant advances in 

safety and effectiveness by satisfying conditions 1 and 2c in Section II (Devices Appropriate for 

Expedited Review). 

Regardless of a device’s stage of development, we encourage industry to discuss potential 

devices that may be appropriate for expedited review as early as possible during their 

interactions with the Center. The following milestones may be good opportunities to assess a 

device’s eligibility for expedited review and to notify FDA of any device that appears to warrant 

expedited review status: 

• pre-investigational device exemption application (IDE) discussions with FDA, including 

formal agreement and determination meetings; 

• IDE meetings where significant findings are presented to FDA; and 

• premarket submission meetings, such as those frequently scheduled with review divisions 

before submitting PMAs, PDPs, and select 510(k)s. 

FDA recommends that industry requests for expedited review of a premarket submission be 

made in writing and accompany any materials submitted in preparation for a meeting or with the 

application that is to be expedited. The request for expedited review should cite the relevant 

expedited review criteria described in this guidance document that have been met and include 

information sufficient to justify the request. In cases where FDA has granted expedited review 

status in advance of the submission of a marketing application, the applicant should include a 

copy of the FDA correspondence with the submission. 

Once FDA grants expedited review status for a submission, industry responsibilities do not end. 

If the expedited review program is to function effectively and efficiently, industry should give 

priority to resolving all scientific and regulatory issues that surface during the review process. 

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This may involve redistributing resources from other activities to resolving pending issues, or by 

responding to FDA requests for additional information in as timely a manner as possible. It will 

only be through a complete and total commitment by all parties involved that expedited review 

will result in safe and effective devices getting to market in as short a time as possible.12

B. FDA Responsibilities 

It is the responsibility of FDA staff to consider whether new devices are appropriate for 

expedited review, regardless of whether a company has identified its device as a potential 

candidate for this program. 

Opportunities for identifying devices that are eligible for expedited review include, but are not 

limited to: 

• pre-IDE discussions with companies, including formal agreement and determination 

meetings; 

• IDE meetings where significant findings may be presented by an applicant; 

• pre-PMA, pre-PDP, and pre-510(k) meetings where scientific and regulatory 

requirements may be discussed; 

• the early phase of FDA review of marketing applications (refer to discussion of specific 

timeframes discussed below); and 

• special considerations described in Section III above. 

C. FDA Timeframes for Determinations 

The Division Director responsible for evaluation of a device is authorized to grant expedited 

review status for a premarket submission, whether requested by the applicant or initiated by 

FDA. Given the public health importance of this decision, we will attempt to reach a decision on 

whether to grant expedited review within the following timeframes: 

• Pre-Submission Communications - When expedited review is a consideration during 

pre-submission communications with companies, review divisions should make a prompt 

determination regarding device eligibility. Whenever possible, FDA expects the review 

divisions to make a determination within two weeks of the request for, or discussion of, a 

particular device’s eligibility for expedited review status. 

• 510(k)s and de novo classification actions - The decision to expedite the review should 

be made within two weeks from the receipt date of the submission. 

12 See also FDA’s guidance document on interactive review entitled, “Guidance for Industry and FDA 

Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, 

Original BLAs, and BLA Supplements,” http://www.fda.gov/cdrh/ode/guidance/1655.html. 

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• PMAs - The decision to expedite the review should be made as early as possible during 

the 45-day filing review.13 For PMA supplements that are filed upon receipt (e.g., 180-

day supplements), the decision should be reached within 30 days of receipt of the 

submission. 

Note: When granting expedited review, the review divisions should consider other pending 

submissions for the same intended use that may also be appropriate for expedited review. 

Likewise, the review divisions should monitor incoming submissions for devices of the same 

type that may also be appropriate for expedited review status. If more than one pending 

submission is appropriate for expedited review, both submissions should be granted expedited 

review status. 

D. FDA Administrative Procedures 

After FDA determines that expedited review is appropriate, the division should complete the 

“Expedited Review Form” (Attachment 2) specifying the basis for its determination. A copy of 

this form, signed by the Division Director, is to be provided to the appropriate Office Director, 

and the 510(k) or PMA Staff, or in CBER, to the Regulatory Project Management Branch. 

The Expedited Review Form also includes certain information regarding resource utilization. In 

completing the form, review divisions should establish: 

• A Review Team – The division should designate a team leader and review team, as well 

as identify resources from outside the division that may be needed to appropriately 

expedite the review; and 

• A Tentative Timeline for Review of the Application – The division should establish a 

timeline for review. Each division should use project management techniques to expedite 

applications and monitor timeframes. CBER should use the structure of a Regulatory 

Project Manager (RPM) and Scientific Lead (SL) to achieve these goals. 

In CDRH, the division will prepare and issue a letter notifying the applicant of the expedited 

review status. In CBER, the Office should prepare the letter notifying the applicant of the 

expedited review status. The notification conveying expedited review status may be 

incorporated into other outgoing correspondence between the applicant and FDA (e.g., a 

response to an IDE or a PMA filing letter). A copy of the notification letter should be included 

in the administrative file according to established procedures, and issuance of this letter should 

also prompt an update of the database to reflect FDA’s granting of a device’s expedited review 

status. 

VIII. Expedited Review Procedures for FDA 

The review division, along with all other CDRH components that may be participating, incur 

specific responsibilities upon granting expedited review. The areas below warrant special 

consideration. 

13 See 21 CFR 814.42(a). 

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A. Resource Management 

The Division Director should ensure that the application is reviewed in the most efficient 

manner, tracked as an expedited review and completed within the MDUFMA timeframes. 

Implementation of this policy may have an impact on other review work of the division. 

Additional resources will likely be necessary for review of the marketing applications granted 

expedited review. The following should be considered, when appropriate, to accommodate the 

expedited review process: 

• assignment of a team leader/project manager to manage the administrative activities 

(such as arranging internal and external meetings and teleconferences, taking meeting 

minutes, etc.); 

• shift in the workload within the affected reviewing division; 

• scientific experts from outside the Center and/or FDA may need to be consulted to 

facilitate review of an expedited application; and 

• scientists from elsewhere in CDRH may be needed to provide support in areas where the 

standard review queue is affected by the workload shift. 

B. Advisory Panel Review 

FDA takes most PMAs that are granted expedited review status to an advisory panel for review. 

The respective review division should make the decision whether a PMA will go to an advisory 

panel, in consultation with the applicant, at the time of the filing decision. While most 510(k)s 

are not taken to panel, the review division should make the decision whether an expedited 510(k) 

submission will go to an advisory panel for review, in consultation with the applicant, at the time 

that the expedited review is granted, which is usually within two weeks of receipt of the 

submission. It is the responsibility of the Division Director to ensure that the decision to bring 

the application or submission to an advisory panel is made within the appropriate timeframe. 

The review team and the respective advisory panel’s Executive Secretary should be involved in 

this process. Information about the procedures for advisory panel review is available at

http://www.fda.gov/cdrh/modact/amendpan.pdf. 

C. Monitoring 

On a quarterly basis, the Office should review the progress of submissions granted expedited 

review status. The purpose of this review will be to provide feedback to the review divisions and 

to offer suggestions for any encountered difficulties. 

D. Public Disclosure 

The fact that FDA has determined a device is eligible for expedited review procedures generally 

will not be disclosed to the public by FDA until the time that marketing authorization has been 

granted, or until the materials are made available in connection with advisory panel meetings for 

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those applications or submissions undergoing panel review.14 Although FDA generally does not 

comment on the status of pending applications, it may release publicly disclosable information if 

it becomes necessary to correct misleading statements made by the applicant. 

At the time of approval or clearance, a publicly disclosable paragraph may be provided to 

appropriate media outlets (through FDA’s Press Office) and FDA information sources (CDRH 

web page, DSMICA, etc.) depending on the significance of the approval or clearance. FDA may 

make public sufficient information to permit interested parties to monitor the agency’s 

implementation of the expedited review program, with the exception of information related to 

expedited reviews granted for the special considerations described in Section III above.15 

14 See http://www.fda.gov/cdrh/ode/guidance/1341.html for information about the public availability of 

the advisory panel materials.

15 Any disclosures will be made in accordance with 21 CFR Part 20 and any other applicable laws 

protecting private, confidential commercial information, and trade secrets. 

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Attachment 1: Suggested Timeframes for Discussing 

Expedited Review with FDA 

Table 1. Suggested Timeframes for Discussing Expedited Review Status (shown in solid 

shading)

Expedited Pre-Submission Product Development Timeline 

Criteria Concept Prototype Pre-clinical Clinical Performance Assessment

1 + 2a opportunities for discussion 

1 + 2b opportunities for discussion 

1 + 2c opportunities for discussion 

1 + 2d opportunities for discussion 

Legend for Table 1:

Criteria for Expedited Review

1. Condition is life-threatening or irreversibly debilitating 

AND

2. the device addresses an unmet medical need, demonstrated by any one of the following: 

a. breakthrough technology 

b. no approved alternative 

c. significant clinically meaningful advantage 

d. in the best interest of patients. 

 

Pre-Submission Product Development Timeline

Phase Primary Activity 

Concept Working up the abstract or generic idea 

Prototype Building first functional, full scale, pre-production model 

Pre-clinical Bench testing prototype and subsequent models 

Clinical Conducting human subject trials 

Performance Assessment Evaluating data from preclinical and clinical phases 

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Attachment 2: Expedited Review Form

Applicant: ____________________________________________________________________ 

Device: ______________________________________________________________________ 

Use/Indications: ______________________________________________________________ 

Document #: ________________________________________________________________ 

Justification for Expedited Review Check if YES ( ) 

1. Does the device affect a condition that is life-threatening or irreversibly debilitating? 

2. Does the device address an unmet medical need, as demonstrated by any one of the 

following:16

 a. breakthrough technology 

 b. no approved alternative 

 c. significant clinically meaningful advantage 

 d. in the best interest of patients. 

 

3. Are the answers to 1 & any one part of 2 a YES response? 

 If yes, go to 4. 

If no, skip to 5. 

Expedited Review Assessment (check only one) 

4. The application qualifies for expedited review status and is subject to MDUFMA 

Performance Goals 

5. The application does not qualify for expedited review status 

Identify review team leader & members: 

Attach tentative review timeline. 

Signature: ________________________________________________ 

Division Director & Date 

 

16 FDA will verify the applicability of any justification proposed. 

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