FDA News and Views: Patient Engagement Collaborative, Case for Quality Pilots, Medical Device Accessories, Malfunction Reporting – Drug and Device Digest

FDA BRIEF: Weeks of Dec 22 and 29

FDA Voice

You Spoke, FDA Listened: New Patient Engagement Collaborative, Call for Nominations 

Patient Engagement Collaborative (PEC)

  • Patients who have personal disease experience
  • Caregivers who support patients
  • Representatives from patient groups who have direct or indirect disease experience
  • Joint endeavor between the CTTI and FDA

PEC forum to discuss

  • More meaningful patient engagement in medical product development
  • Incorporating various perspectives into regulatory decision-making processes
  • Builds on existing  Patient Focused Drug Development (drugs, biologics)  and the Patient Preference Initiative (medical devices)
  • Modeled after the European Medicines Agency’s Patients’ and Consumers’ Working Party

Nomination ProcessREAD


Case for Quality Pilot Activities

Case for Quality

  • Allows FDA identify device manufacturers consistently producing high-quality devices
  • Focus FDA resources helping other manufacturers raise quality level
  • Identify and promote practices supporting consistent quality manufacturing, and align regulatory, enforcement, compliance approaches

1. Premarket Approval (PMA) Critical-to-Quality Pilot Program

  • PMA device manufacturers meeting participation criteria to engage with FDA early in review process of new applications
  • Proactive engagement to develop critical-to-quality characteristics and controls  and a focused inspectional approach
  • Streamline the premarket approval process while assuring quality system
  • FDA to forego pre-approval inspection, instead conduct post-approval inspection

2. Voluntary Medical Device Manufacturing and Product Quality Pilot Program

  • Third-party teams certified by Capability Maturity Model Integration (CMMI) Institute to conduct quality system maturity appraisals of device manufacturers
  • Drive continuous improvement and organizational excellence
  • Engage early with CDRH and submit baseline metrics before and during appraisal to monitor progress
  • FDA to forego conducting surveillance and preapproval inspections

3. Digital Health Software Precertification (Pre-Cert) Program

  • Modern and tailored approach for software iterations and changes
  • Enable companies demonstrate their embedded culture of quality and organization excellence (CQOE)
  • FDA to learn, adapt, adjust key elements based on program effectiveness

4. Digital Health Entrepreneurs-in-Residence Program

  • Entrepreneurs work intensively with FDA Digital Health Unit staff to iteratively develop and test key conceptual elements of  software precertification program

5. Medical Device Single Audit Program (MDSAP)

  • Global approach to auditing and monitoring manufacture of medical devices
  • MDSAP recognized Auditing Organization to conduct single regulatory audit of manufacturer to satisfy requirements of multiple regulatory authorities : US, Australia, Brazil, Canada, Japan, WHO, EU



Medical Device Accessories

Intended Use : Finished device intended to support, supplement, and/or augment performance of one or more parent devices

Accessory Classification Request: Written request for appropriate classification

Classification of New Accessory Type: Submitted together with the parent device submission or submitted separately as De Novo Classification Request

  • Submit necessary information, based on Least Burdensome principles, to establish  risk profile of accessory when used as intended with parent device
  • Class II must include an initial draft proposal for special controls,

FDA Consulation: Prior to Accessory Classification Request – through Pre-Submission



Voluntary Medical Device and Combination Products Malfunction Summary Reporting

Manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form

  • Streamlining malfunction reporting
  • Permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format
  • Reflecting FDA’s findings from pilot program to study summary reporting formats for malfunction MDRs.


Image credits: FDA


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