US FDA presents premarket submissions pilot program and patient-centered data resource pages

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.

New pilot program will test the suitability of Box software for premarket submissions

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.

Resource pages provide guidance on Clinical Outcome Assessments and Patient Preference Information

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:

• an introduction to the type of information under consideration;
• an explanation of how the CDRH utilizes it;
• a hyperlinked list of CDRH collaborations, studies, workshops, and articles on the subject; and
• guidelines for companies interested in beginning to incorporate the information source into their business practices.

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.

Learn more about US FDA medical device regulations at Emergo by UL:

• US FDA 510(k) consulting for medical device and IVD companies
• FDA submission support for medical devices and IVDs
• Whitepaper: Medical device testing requirements for FDA 510(k) submissions
• Whitepaper: Early communication with the US FDA