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U.S. Department of Health and Human Services

Medical Devices

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The 2nd Pilot Program Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications (2010)

June 15, 2010

To: U.S. Cardiovascular Industry

From: Dr. Jeffrey E. Shuren, Director, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)

Announcement of the 2 nd Pilot Program on Sharing Information Between the US FDA and Japan MHLW/PMDA (Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency) Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications.

Last year MHLW/PMDA and FDA launched the initial pilot program on collaborative consultation and review of new medical devices on June 15, 2009. The goal of the pilot program is to improve both the speed and quality of the consultation and review stages, allowing for potential earlier market access and an increased benefit to public health. This collaboration would permit the regulatory review staff of both MHLW/PMDA and FDA to discuss the contents of an individual submission in order to gain valuable regulatory information pertaining to device development and clinical trial design. After careful consideration on the outcome of the current pilot program, MHLW/PMDA and FDA decided to continue this effort and are now soliciting submissions for new medical devices for collaborative consultation and review under the 2 nd pilot program (2010).

1. Criteria

Sponsors should demonstrate that their candidate medical device fulfills all criteria listed below.

  1. The product is a new device in the cardiovascular/endovascular field and is intended for marketing approval in both the US and Japan.
  2. Development status of the device is similar in the US and Japan. Clinical trials of the device will be conducted with a single (or similar) protocol in the US and Japan.
  3. The sponsor of the candidate device must have early consultations with PMDA and FDA/CDRH when planning clinical trials, unless the clinical trials for the device are already being conducted in Japan and or the US.
    Status of Clinical Trials Initiate Consultations with Regulators
    Japan US Japan US
    Not Started Not Started Yes Yes
    Not Started Conducted Yes No
    Conducted Not Started No Yes
    Conducted Conducted No No
  4. The sponsor of the candidate medical device should provide the same information to MHLW/PMDA and US FDA. The sponsor should also provide English translations to MHLW/PMDA upon request from MHLW/PMDA.

2. Application Process and Confidentiality

  1. Interested sponsors should submit an application letter to the FDA (see Appendix 1) and MHLW/PMDA by July 30, 2010. Additionally, the sponsor should provide to the FDA an English version of the application letter submitted to MHLW/PMDA.
  2. The sponsor of the selected medical device will be requested to submit an “Authorization to Share Confidential and/or Trade Secret Information with a Foreign Government” (see Appendix 2) that authorizes FDA to share information with MHLW/PMDA. FDA and MHLW/PMDA have the authority to protect from public disclosure any non-public information provided in confidence. The sponsor must also contact MHLW/PMDA and submit a similar authorization letter to MHLW/PMDA. Please send a copy of the letter in English to FDA.

3. Selection Process and Type of Communication Mechanism

  1. Continuous Communication under the Collaborative Scheme
    MHLW/PMDA and FDA will consider medical devices from the pool of Japanese and US industry sponsors who submitted an application nominating their device for this pilot program. MHLW/PMDA and FDA will conduct a joint evaluation of the nominated medical device(s) for eligibility to participate in the pilot program. Similar to 2009, a maximum of two medical devices will be initially selected, but there may be cases where there are no devices selected if the candidate devices are not eligible or suitable for the pilot program.
  2. One-time Interaction
    In addition to the continuous communication described above, another type of communication mechanism is available to the sponsor. MHLW/PMDA and FDA will also grant a one-time, one-topic, three-way discussion for selected devices. The consultation is to occur within one year of the selection date. Scheduling of the one-time interaction must be submitted in writing and agreed upon by both regulatory agencies. If a sponsor accepted for a one-time interaction proposes to have the three-way consultation with both regulatory agencies beyond the one year timeframe, the sponsor should submit a written request for consideration. Both FDA and MHLW/PMDA must agree to the proposed extended timeline. A maximum of five to ten medical devices will be initially selected.
    The sponsor can apply to one or both types of communication mechanism described in sections 3.1. and 3.2. above. Submitting applications to both types does NOT guarantee their selection for either the Continuous Communication under the Collaborative Scheme (3.1) or the One-time Interaction (3.2) communication mechanism.

4. Option to Withdraw

A participating sponsor may withdraw from the pilot program at any time. The sponsor is free to pursue the normal regulatory process in each agency individually.

For Further Information Contact:

Carole C. Carey, Center for Devices and Radiological Health (WO66-4618), Food and Drug Administration at Federal Research Center White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002. Telephone: 301-796-5708. E-mail: carole.carey@fda.hhs.gov.


 Appendix 1 - Application Letter

MM/DD/YYYY

 To: Carole C. Carey
Director, International Relations and External Affairs Staff
Medical Devices, Coordinator for Global HBD (Harmonization By Doing) Programs
Center for Devices and Radiological Health (CDRH)
White Oak Building 66-4618
U.S. Food and Drug Administration (FDA)
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
USA

 From: Mailing Address (address of headquarter)
Name (name of a company and its representative)
(Company A) would like to nominate the following medical device for the 2 nd pilot program on collaborative consultation and review between Japan MHLW/PMDA and US FDA.

  1. Device Classification Name
  2. Product Code
  3. Device/Trade Name
  4. Characteristics of the product
    1. Intended use
    2. Shape, structure and mechanism
    3. Method or instruction of use
    4. Novelty of the product
    5. Potential public health benefit of the product
    6. Status of development in US and Japan including schedules of consultation with authorities and expected date of submission
    7. Explanation of benefit of this program on sharing information for the product development (If there are issues in global development to be addressed by application for the program, please identify them.)
  5. Preferred type of communication mechanism to share information: Continuous Communication under the Collaborative Scheme (see section 3.1.) and /or the One-time Interaction (see section 3.2.).
  6. Name and address of firm’s contact person.

Appendix 2 - Model

SPONSOR'S AUTHORIZATION FOR FDA TO SHARE CONFIDENTIAL COMMERCIAL AND/OR TRADE SECRET INFORMATION WITH A FOREIGN GOVERNMENT OR INTERNATIONAL ORGANIZATION

(SPONSOR SHOULD PREPARE ON ITS LETTERHEAD)

Mary Lou Valdez, Associate Commissioner for International Programs Office of International Programs United States Food and Drug Administration Building 31, Room 3426, 10903 New Hampshire Avenue, Silver Spring, MD 20993.

RE: FDA Sharing of Non-Public Information concerning [Insert Name of Regulated Product(s)] with [Insert name of foreign agency]

Dear Associate Commissioner Valdez:

On behalf of [insert name of sponsor], the sponsor of the above-referenced regulated product(s), I authorize the United States Food and Drug Administration (FDA) to share the information described below with the [insert name of foreign agency] solely for the purpose of [insert description of purpose]. I understand that the information may contain confidential commercial information or trade secrets within the meaning of 18 U.S.C. § 1905, 21 U.S.C. § 331(j), and 5 U.S.C. § 552(b)(4) and/or information described in 21 U.S.C. § 360j(c). I agree to hold FDA harmless for any injury caused by FDA's sharing the information with [insert name of foreign agency].

Information to be shared: [provide accurate description of information]:

Authorization is given to FDA to send the above-mentioned information without deleting confidential commercial or financial or trade secret information. As indicated by my signature, I am authorized to provide this consent on behalf of [insert name of company] and my full name, title, address, telephone number, and facsimile number is set out below for verification. I am sending a copy of this letter to the foreign government agency or international organization with which FDA may share the information.

Sincerely,

(Signature)

(Printed name)

(Title)

(Telephone & Facsimile Numbers)

cc: Name of foreign government or international organization