Devices

CDRH Working to Improve Patient-Reported Outcomes

CDRH says it is actively working to increase appropriate use and improve the impact of PROs (patient-reported outcomes) as evidence in regulatory decisions and beyond. The Center makes the commitment in a strategic priority document — Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices.

It says its report is intended to:

encourage the appropriate use of PROs in regulatory studies and decisions, and summarize the Center’s efforts and accomplishments to date;
inform medical device sponsors of case examples and other available resources to facilitate PRO data collection in pre- and postmarket clinical studies;
outline initial plans for addressing focus areas where the use of PROs is beneficial in regulatory submissions, and
identify areas of interest for potential future collaboration with stakeholders.

The document defines a PRO as “a measurement based on a report that comes directly from the patient (study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else.” Simply put, it says, a PRO is a measurement of patients’ perceptions of their own health status or quality of life. “Our interest,” CDRH says, “is in those PROs that assess what is important to patients with the applicable disease or condition for which the PRO is being used.”

“CDRH is working collaboratively with our customers to increase appropriate use and increase the value of PROs as evidence in regulatory decisions and for other, non-FDA purposes,” the report concludes. “Our efforts to date, including staff training, assessment of various PRO uses across CDRH, and development of resources for industry and staff, have reduced barriers to appropriate use and improved the regulatory impact of PROs. We are committed to continuing to advance the science of patient input and its use in the regulatory process through MDUFA 4 and thereafter.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome