Oct 21, 2020
The US FDA’s Center for Devices and Radiological Health (CDRH) has introduced a new pilot program for a different method of electronic premarket submissions pertaining to medical devices, and it has published resource pages for manufacturers and stakeholders interested in incorporating patient-centered data sources into their decision-making processes.
The CDRH announced the launch of the Electronic Delivery of Premarket Submissions Pilot, which provides an optional alternative method for medical device premarket submissions during the COVID-19 health emergency. According to the announcement, which is structured as a series of questions and answers, the Pilot will last for 90 days and is designed to test the CDRH’s capability to receive premarket submissions using the cloud-based filesharing service Box.
Up to 25 volunteers will be selected based on the eligibility criteria and process outlined in the announcement. The FDA is currently soliciting feedback from interested parties including, but not limited to, Pilot participants regarding the suitability of Box for premarket submissions.
The CDRH also published new pages providing an overview of resources on the use of Clinical Outcome Assessments (COAs) and Patient Preference Information (PPI) for the purpose of informing medical device decision-making. According to the FDA’s definition provided here, a COA “describes or reflects how a person feels, functions, or survives” and can be reported by a healthcare provider, a non-clinical observer, or by the patient through performance of a dedicated activity or task. PPI is a type of patient experience data that identifies the value patients assign to aspects of a given medical device and that “accounts for differing patient perspectives on benefits and risks” associated with the device.
Each page includes the following sections:
Manufacturers and stakeholders who are interested in incorporating COAs in their regulatory submissions or planning to conduct a PPI study may find these pages to be useful sources of guidance for getting started and for refining practices throughout a product’s lifecycle.
The Agency explains best practices for developing and changing PRO instruments to inform the medical device evaluation process.
US FDA progress report on Pre-Cert registration program for Software as a Medical Device
These tools are developed by the Office of Science and Engineering Labs to aid in the development of new medical devices.