June 3, 2021



Patient inputs have always remained the core for healthcare systems, healthcare professionals & medical equipment manufacturers. Especially in the age of social media, the user or the patient has the power to influence the manufacturers. Hence, as a part of the FDA Reauthorization Act of 2017, the Patient Preference Information (PPI) was enforced by incorporating the CDRH’s (Centre for Devices and Radiological Health) Regulatory decision.      

  • The PPI was brought into action by the FDA to ensure that the information was collected at a single place so that manufacturers and other healthcare professionals would be able to understand the disease better
  • FDA is seeking public feedback on a list of patient preference areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and post-market evaluation
  • The PPI can be conducted by patient groups, members of the medical device industry, researchers and healthcare providers
  • PPI is useful in evaluating a device’s benefit-risk profile.
  • Patient decisions are considered Preference sensitive while evaluating devices benefit risk profile using PPI

       Submission of PPI

  • Submission can be electronic or paper-based. All electronic submissions are made public and available for the medical device manufacturer. The electronic submissions are made using the Federal eRulemaking Portal: www.regulations.gov
  • Another mode of submitting the PPI is by paper, to the following address: “Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852” 
  • The patient or the submitter has the option to provide their information as confidential and non confidential

For actively making an effort in promoting the patients and healthcare professionals to provide feedback, the PPI seeks input on several parameters like 

  • Conducting clinical studies and PMCF (Post-Market Clinical Follow-up)
  • Better use of the device and make it more user-friendly

PPI may be considered as best at various decision points in a patient-centered product development program. For future development stages, PPI is considered as a dataset which can be built upon. Active regulatory and quality involvement is important in making the best use of information from PPI such that the device technologies are continuously looked at to identify any opportunity of improvement.

#fda#regulatory#cemarking#iso13485#medical device#healthcare#qualityassurance#clinicaltrials#pma#denovo#510k#patient#technologies

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