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Early Collaboration Meetings |
Document issued on: February 28, 2001
This document supersedes: Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Guidance for Industry and CDRH Staff, February 19, 1998)
U.S. Department of Health and Human Services Program Operations Staff |
Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the Docket number 98D-0078 and the exact title and date of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance contact Thinh Nguyen at (240) 276-4010.
Additional Copies
Additional copies are available from the World Wide Web at http://www.fda.gov/cdrh/ode/guidance/310.html, or CDRH Facts-On-Demand at 1-800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system and enter the document number 310 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Early Collaboration Meetings
Under the FDA Modernization Act (FDAMA);
Final Guidance for Industry and for CDRH Staff
This document is intended to provide guidance. It represents the Agency’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 the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Guidance on Standard Operating Procedures
FDAMA provides for two early collaboration meetings. These meetings are
intended to facilitate interaction between FDA and applicants and provide clear
direction for testing and development of those devices requiring clinical
investigations to support marketing.
Determination Meeting
A Determination Meeting, as described in §513(a)(3)(D), is available to anyone anticipating submitting a PMA or PDP and is intended to provide the applicant with the Agency’s determination of the type of valid scientific evidence that will be necessary to demonstrate that the device is effective for its intended use. As a result of this meeting, FDA will determine whether clinical studies are needed to establish effectiveness and, in consultation with the applicant, determine the least burdensome way of evaluating device effectiveness that has a reasonable likelihood of success. The applicant can expect that FDA will determine if concurrent randomized controls, concurrent non-randomized controls, historical controls, or other types of evidence will be acceptable. FDA’s determination is to be written, shared with the applicant within 30 days following the meeting, and is binding upon the Agency, unless it would be contrary to public health.
Agreement Meeting
The other opportunity for a meeting established by FDAMA is an Agreement Meeting, described in §520(g)(7), which is open to any person planning to investigate the safety or effectiveness of a class III product or any implant. Thus, unlike the Determination Meeting, the Agreement Meeting is available to submitters of 510(k)s for eligible devices. The purpose of this meeting is to reach agreement on the key parameters of the investigational plan (see 21 CFR 812.25), including the clinical protocol. The meeting is to be held within 30 days of the receipt of a request for such a meeting. Any agreement reached in this meeting is also to be written, shared with the applicant, and made part of the administrative record. It is binding on the Agency and may be changed only with the written agreement of the applicant or when there is a substantial scientific issue essential to determining the safety or effectiveness of the device.
Background
Prior to the passage of FDAMA, the Office of Device Evaluation (ODE) had encouraged IDE sponsors to obtain Agency advice on their proposed bench/animal testing as well as on the design of their clinical trials before submitting an investigational device exemption (IDE) application. Such interactions, referred to as "pre-IDEs," allow the Agency to provide early feedback to sponsors and, in so doing, help to facilitate approval of the IDE. Pre-IDE meetings are informal, and the feedback is non-binding on either party. FDA encourages applicants to continue to take advantage of these informal communications, as outlined in IDE Guidances #D95-1, "Goals and Initiatives for the IDE Program" and #D99-1, "Pre-IDE Program: Issues and Answers." FDAMA, for the first time, provides for formal collaboration meetings (Determination and Agreement) where the results of the meetings are now binding.
The Determination and Agreement Meetings should take place early in the development of the device so the applicant may use the meeting results to plan efficiently for the appropriate study. FDAMA is silent as to whether these early collaboration meetings are individual events or part of an ongoing dialogue with the applicant. Experience and practicality suggest that, particularly with novel device/technologies, prior dialogue is critical to the effectiveness of these formal binding meetings. Preliminary discussions can help clarify and focus on the key issues to be addressed in the pre-submission materials and in the meetings themselves. Preliminary discussions may also help an applicant decide between the use of formal binding meetings and informal meetings. Depending on FDA’s familiarity with the device and the degree to which relevant precedents exist, one or more informal meetings may be useful before a Determination or Agreement meeting can be productive.
A graphical illustration of how early collaboration meetings fit into this communication continuum is presented below. The x-axis represents the device development timeline, while the y-axis represents the amount known about the device.
Figure 1: Graphical illustration of a typical approach to communication about a new device. Vertical arrows illustrate typical timing of potential communications between the sponsor and the Agency; not all will be applicable to every device. Informal communications are also encouraged throughout the device development process.
In recognition that the Agency will not be able to reach useful conclusions unless a fair amount of planning and commitment have been undertaken by the applicant prior to the meeting, FDAMA requires that the applicant submit a formal package to the Agency at the time of the request. According to FDAMA, the applicant requesting a meeting shall include: (1) a detailed description of the device; (2) a detailed description of the proposed conditions of use; (3) a proposed plan for determining whether there is a reasonable assurance of effectiveness; (4) if available, information regarding the expected performance of the device; and (5) a detailed clinical protocol (for the Agreement Meeting).
With preliminary discussions and good planning, a Determination or Agreement Meeting should be completed in one session. While it is expected that well-prepared attendees will normally reach consensus on the substantive issues during the course of the meeting, there may be occasions when new issues emerge from the discussion. For this reason, it is important that the applicant firm be represented by someone who has the authority to speak for the firm so that agreement on these new issues may be reached. Infrequently, unresolved issues may remain at the end of the meeting. In these exceptional situations, the applicant may request that the issue(s) be tabled and the meeting suspended. Upon mutual agreement, the early collaboration meeting would be reconvened at a future time acceptable to both parties to permit additional, relevant information to be considered by FDA staff before a binding determination or agreement is reached.
FDAMA makes it clear that the determinations or agreements resulting from these meetings are to be binding. In the case of a Determination Meeting under §513(a)(3)(D), the determination regarding valid scientific evidence is binding on the Agency and cannot be changed unless FDA concludes that adhering to it could be contrary to public health. Further, the Agency is to specify if clinical data are necessary to establish device effectiveness. In deciding what type of clinical studies should be conducted, if any, the Agency is charged with considering, in consultation with the applicant, the least burdensome way of evaluating device effectiveness that has a reasonable likelihood of success. In the case of an Agreement Meeting under §520(g)(7), the agreement is binding on the Agency. FDAMA specified that the Agency may only change the agreement when a substantial scientific issue essential to determining the safety or effectiveness of the device has been identified, and only following an opportunity for the applicant to meet with FDA to discuss the scientific issue involved.
The binding nature of the agreement or determination is predicated on the applicant not significantly changing the bases of the agreement or determination (e.g., intended use and indications, product design, investigational plan, clinical study protocol, etc.). If these bases are significantly changed, then the agreement or determination will have been abrogated and the Agency's agreement or determination will no longer be in effect.
Finally, it should be noted that the two new statutory provisions do not address other pre-submission meetings or topics outside the scope of the agreement or determination. That is, the meetings are not intended to serve as pre-PMA submission meetings to discuss formatting of the application or the strength of a particular clinical data set already produced by a potential PMA applicant. Pre-PMA submission meetings to address these types of issues should continue to be held; however, FDA staff should clarify to the applicant that the meeting is intended to help guide the PMA submission, but it is not a FDAMA-mandated meeting that will result in a binding agency commitment. Similarly, the Agreement/Determination Meetings should stay focused on the relevant issues at hand. Other topics, such as the value of a feasibility study or the type of data needed to support a labeling claim, may arise. Because such discussions are outside the scope of this type of meeting, these discussions should be left to the informal meetings.
Determination Meeting
Applicant Activities
Meeting Preparation
The Meeting
Meetings may be face-to-face, by videoconference, or by teleconference and should be scheduled for approximately 1-2 hours. It is important to note that the meeting format will generally be different for a pre-meeting than for the formal meeting. At a pre-meeting, the applicant should present and discuss the material submitted to the Agency. The Agency attendees should raise any questions for the applicant and request any additional information to be submitted prior to the formal meeting. Finally, the key issues to be addressed in the determination should be identified. At the formal meeting, the discussion should be focused on these key issues, leading to the Agency’s determination.
Post-Meeting Activities
Agency Activities
Meeting Preparation
The Meeting
See the section with this title on the previous page.
Post-Meeting Activities
1 "A Systems Approach to Premarket Review" was issued on July 17, 2000 and may be found on CDRH’s website at: www.fda.gov/cdrh/ode/guidance/prerevapproach.html
Agreement Meeting
Applicant Activities
Meeting Preparation
The Agency expects that the submission should be approximately 10-20 pages
in length.
The Meeting
Meetings may be face-to-face, by videoconference, or by teleconference and should be scheduled for approximately 1-2 hours. It is important to note that the meeting format will generally be different for a pre-meeting than for the formal meeting. At a pre-meeting, the applicant should present and discuss the material submitted to the Agency. The Agency attendees should raise any questions for the applicant and request any additional information to be submitted prior to the formal meeting. Finally, the key issues on which agreement is to be reached should be identified by the applicant. At the formal meeting, the discussion should be focused on these key issues, hopefully, resulting in a number of areas of agreement.
Post-Meeting
Agency Activities
Meeting Preparation
The Meeting
See the section with this title on the previous page.
Post-Meeting
FDA’s Evaluation of the Application of the Least Burdensome
Principles
in Early Collaboration Meetings
Type of Meeting:
___ Determination Meeting §513(a)(3)(D)
___ Agreement Meeting §520(g)(7)
Division/Branch: ______________________________________________________
Application Number: ___________________________________________________
Sponsor: ____________________________________________________________
Device: _____________________________________________________________
In the early collaboration meeting with the sponsor, were the Least Burdensome principles applied in:
___ Yes ___ No |
Explain: _______________________________________________________________ _____________________________________________________________________
___ Yes ___ No |
Explain:_______________________________________________________________ _____________________________________________________________________
___ Yes ___ No |
If yes, check the following:
i. Literature control | ___Yes ___ No |
ii. Historical control | ___ Yes ___ No |
iii. Non-active control | ___ Yes ___ No |
iv. Patient as their own control | ___ Yes ___ No |
v. Objective Performance Criteria | ___ Yes ___ No |
vi. Other | ___ Yes ___ No |
If other, describe: ___________________________________________________________
If alternatives could not be used,
explain:__________________________________________
_________________________________________________________________________
___ Yes ___ No |
Explain: ________________________________________________________________
________________________________________________________________________
___ Yes ___ No |
Explain: ________________________________________________________________
_______________________________________________________________________
___ Yes ___ No |
Explain:_________________________________________________________________
________________________________________________________________________
___ Yes ___ No |
Explain:_________________________________________________________________
________________________________________________________________________
___ Yes ___ No |
If yes, describe:
_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
____________________________________________
Team Leader signature Date
Sponsor’s Evaluation of the Application of the Least
Burdensome Principles
in Early Collaboration Meetings
Type of Meeting:
___ Determination Meeting §513(a)(3)(D)
___ Agreement Meeting §520(g)(7)
Division/Branch:________________________________________________________
Application Number:_____________________________________________________
Sponsor:_______________________________________________________________
Device:_________________________________________________________________
In the early collaboration meeting with the sponsor, were the Least Burdensome principles applied in:
___ Yes ___ No |
Explain: ________________________________________________________________ __________________________________________________________________________
___ Yes ___ No |
Explain: ________________________________________________________________
________________________________________________________________
___ Yes ___ No |
If yes, check the following:
i. Literature control | ___ Yes ___ No |
ii. Historical control | ___ Yes ___ No |
iii. Non-active control | ___ Yes ___ No |
iv. Patient as their own control | ___ Yes ___ No |
v. Objective Performance Criteria | ___ Yes ___ No |
vi. Other | ___ Yes ___ No |
If other, describe: ________________________________________________________
If alternatives could not be used, explain:______________________________________ ________________________________________________________________________
___ Yes ___ No |
Explain: ________________________________________________________________ _______________________________________________________________________
___ Yes ___ No |
Explain: ________________________________________________________________ _______________________________________________________________________
___ Yes ___ No |
Explain:_________________________________________________________________ ________________________________________________________________________
___ Yes ___ No |
Explain:___________________________________________________________________
___ Yes ___ No |
If yes, describe: _____________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________
Applicant Contact Name and Phone Number (Optional):_______________________________
Once completed, fax to Ms. Wanda Sawyer-Major at (301) 594-2977
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