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U.S. Department of Health and Human Services

Medical Devices

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Third Year into the Pilot Program: Medical Device Collaborative Consultation and Review of Premarketing Applications (2011)

June 16, 2011

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 Pilot Program on its Third Year, "Sharing of Information between the US FDA and Japan MHLW/PMDA (Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency) Regarding the Medical Device Collaborative Consultation and Review of Premarketing Applications"

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 2011 submissions for new medical devices for consideration in the collaborative consultation and review pilot program.

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 29, 2011. 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. Options for Collaboration

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 and 2010, 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.

If a sponsor desires to have MHLW/PMDA and FDA exchange information regarding a device submission after the application period stated in section 2(1) above, the sponsor may contact FDA and MHLW/PMDA with this request. MHLW/PMDA and FDA may exchange information, as appropriate, and the sponsor will be notified whether or not the information exchange will take place.

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 2nd 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. 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
5600 Fishers Lane (HFG-1) Rockville, MD 20857

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 or financial 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) that is exempt from public disclosure. 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