Pilot Program Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications

June 15, 2009

To: U.S. Cardiovascular Industry

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

Announcement of a 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.

MHLW/PMDA and FDA are announcing the launch of a pilot program on collaborative consultation and review of new medical devices. 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. This announcement aims to solicit submissions for new medical devices for collaborative consultation and review under this pilot program.

Interested sponsors should submit an application letter to the FDA (see Appendix 1) and MHLW/PMDA by July 31, 2009.

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. Selection process and Confidentiality 

1. 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 for eligibility to participate in the pilot program; one or two medical devices will be initially selected. MHLW/PMDA and FDA will balance the selection process between Japan and US. 
   
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. 
   

3. 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), Food and Drug Administration at Federal Research Center White Oak, 10903 New Hampshire Ave
Silver Spring, MD 20993, 301-796-5708.

________________________________________

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)
U.S. Food and Drug Administration (FDA)
10903 New Hampshire Ave
White Oak - Building 66
Silver Spring, MD 20993
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 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.)

____________________________________________

Appendix 2

　

MODEL SPONSOR'S AUTHORIZATION FOR FDATO 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

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