FDA BRIEF: Weeks of Dec 22 and 29
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
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