NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)

PA-16-335
NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)
Department of Health and Human Services
National Institutes of Health

Medical Equipment
Includes a medical mask, syringe, stethoscope, gloves, scissors, and gauze. The selective focus is on the syringe needle.
Section I. Funding Opportunity Description

The National Heart, Lung, and Blood Institute (NHLBI) announces a pilot program to encourage Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees that are developing and testing technologically innovative or substantial risk medical devices (diagnostics or therapeutics) to engage in early face to face interactions with the FDA Center for Devices and Radiological Health.

Medical device companies spend significant amounts of time, money, and resources developing new technologies based upon a best-guess approach regarding regulatory requirements. For new types of technologies and for high risk devices, even a development plan that is based upon information from public sources – such as Food and Drug Administration (FDA) databases of approvals and clearances, and from professionals with relevant experience – has the potential for generating delays in product development if it is created in the absence of feedback from the FDA.  An early meeting with FDA to validate their development plans can ensure that companies do the appropriate work at the appropriate time and can minimize or eliminate the need to repeat expensive and time consuming studies which can exhaust their limited resources. Although the FDA is noted for saying “come early, come often,” some medical device developers are wary of interacting with the Center for Devices and Radiological Health (CDRH) too early in their development program due to concerns that the CDRH may impose regulatory requirements early in development that are more stringent than those they would need to meet if their technology were more fully developed. CDRH has recently issued guidance documents describing changes to their regulatory approach, including the Expedited Access Pathway Program, the Early Feasibility Studies program, and Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. CDRH has also worked collaboratively with early stage technology developers to understand the nuances of developing regulatory strategies that fit small business development budgets and timelines (http://medcitynews.com/2015/09/fogarty-institute-hey-medtech-startups-fda-is-your-friend/). These announcements and activities are evidence of a commitment by CDRH to openly engage with the newest types of technologies – such as those represented in their small business portfolios – and wish to encourage their portfolio companies to take advantage of CDRH’s new programs. Furthermore, due to the unique three dimensional aspects of medical devices, NHLBI perceives great value for their portfolio companies to meet in-person with CDRH so that prototypes or components of their technologies can be handled, manipulated, and examined by all attendees.

Companies selected for supplement awards can anticipate an NHLBI-facilitated introduction to a CDRH Coordinator in the appropriate CDRH review division where their technology will be regulated. The CDRH Coordinator will:

  • Introduce the company to the US regulations relevant to the selected technology
  • Talk with the company to more fully understand the technology under development
  • Describe the process of CDRH regulation for the technology type
  • Frame the conversation for a face-to-face meeting
  • Engage appropriate CDRH Senior managers and review staff members with technology-relevant expertise to participate in a face-to-face meeting

The primary outcomes of the face-to-face meeting will be collaborative drafting of a least-burdensome development plan to guide the technology toward submission for first in human or first in US use under an Investigational Device Exemption (IDE), and the development of a relationship between the development team and the CDRH review team. Final guidance on the Least Burdensome approach can be accessed at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf .

It is anticipated that participation in this pilot program will encourage and enable:

  • Increased awareness of CDRH regulatory requirements by SBIR/STTR awardees
  • Increased collaboration between NIH and FDA related to the development of new biomedical therapeutic and diagnostic devices
  • Phase II and Phase IIB SBIR/STTR applications with Research and Commercialization plans that are aligned with regulatory milestones
  • Reduced total time to FDA regulatory clearance or approval for innovative devices as compared to technologies that do not receive early input from the FDA
  • Increased U.S.-based clinical development of highly innovative medical devices (diagnostics and therapeutics)

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-335
Funding Opportunity Title: NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.233 — National Center on Sleep Disorders Research
93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.840 — Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Cost Sharing or Matching Requirement: No
Posted Date: Jun 15, 2016
Last Updated Date: Jun 15, 2016
Original Closing Date for Applications: Aug 15, 2016  
Current Closing Date for Applications: Aug 15, 2016  
Archive Date: Sep 15, 2016
Estimated Total Program Funding:
Award Ceiling: $5,000

Eligibility

Eligible Applicants:
Small businesses
Additional Information on Eligibility: Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this administrative supplement is to provide support to current SBIR and STTR awardees interested in working collaboratively with the FDA’s Center for Devices and Radiological Health (CDRH) to develop strategies for early stage development so that they may bring innovative products to the marketplace more efficiently.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-335.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

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