Michelle's Moment: FDA Speaks Out to Congress on Innovation Blog Feature
Michelle Lott

By: Michelle Lott on May 4th, 2015

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Michelle's Moment: FDA Speaks Out to Congress on Innovation

Regulatory Compliance

rally-speech-510Pulse Check: FDA Speaks Out to Congress on Innovation

Michelle's Moment: In a recent address to Congress, FDA laid out four key steps to facilitate approval of innovative products:

  1. Patient-informed product development
  2. Development of "biomarkers" and surrogate endpoints
  3. Use of existing clinical experience and data
  4. FDA's ability to retain personnel qualified to understand and support innovation

While the FDA was telling the Senate areas where Congressional support was needed to support the advancement of medical innovation, the savvy medical device developer will read between the lines and understand key elements to a successful regulatory submission strategy hidden in the message.

Over the last several years, FDA has developed many strategic initiatives, new guidance documents, and public-private partnerships that are consistent with the message sent to Congress in March. If industry has been paying attention to regulatory change, the following correlation should be noted:

Recommendation to Congress Related FDA Activity Release Date
Patient-informed product development Listening to Pateint's Views on New Treatments for Obesity 01/29/2015
  Want to Unlock the 21 Century Cure? Hearing Witnesses Agree, Patient Input is Key 07/16/2014
  FDA Draft Guidance on Duchenne Muscular Dystrophy 06/25/2014
Development of "biomarkers" and surrogate endpoints Medical Device Development Tools: Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff 11/14/2014
  Medical Device Development Tools (MDDT) Pilot Program 08/14/2014
  The FDA's push for better biomarkers 09/18/2014
  FDA Issues Draft Guidance to Expedite Device Development 11/18/2013
  Medical Device Innovation Consortium  
  Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications 03/28/2012
Use of existing clinical experience and data The Brookings Institution Issues Report on National Medical Device Surveillance System 03/02/2015
  Moving Toward a National Medical Device Postmarket Surveillance System 02/23/2015
  Implementing the UDI System into Health Care Systems in Critical to Reaching its Potential to Benefit Public Health 12/09/2014
  Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notification [510(k)] with Different Technological Characteristics: Draft Guidance 07/15/2014
  FDASIA Health IT Report - Proposed Strategy and Recommendations for a Risk-Based Framework 04/07/2014
  Unique Device Identification 09/24/2013
FDA's ability to retain personnel qualified to understand and support innovation FDA Strategic Priorities 2014-2018 09/2014
  Paving the Way for Personalized Medicine - A New Era of medical Product Development 10/2013

In short, developers of medical products should be thinking in terms of the first three initiatives starting now to ensure an expeditious submission review time. While the FDA activities are still in the early stages of development and implementation, they paint a picture of the types of information and data that the FDA finds helpful in product clearance or approval.

Wise developers will build at least some elements of these initiatives into their design plans, risk management, usability, verification or validation testing, and finally their submission to facilitate the path to commercialization. At the very least, companies should be transitioning their design teams to approach medical product design with these new paradigms so the teams are prepared when new FDA requirements are finalized.

FDA spoke and told medical innovators what they want to see. Did you listen?