Sep 22, 2015
The US Food and Drug Administration has begun forming a new Patient Engagement Advisory Committee (PEAC) to improve communications with patients and users on various clinical and regulatory issues involving medical devices.
According to the FDA’s announcement and accompanying blog post, the formation of the new committee reflects a trend toward “patient-centered” healthcare in which the agency will make more of an effort to include patient perspectives in regulatory and clinical processes.
As planned, the PEAC will have nine voting members appointed by the FDA commissioner from clinical research, primary care and patient advocacy sectors. The commissioner may also appoint non-voting members nominated by industry participants to attend individual PEAC meetings.
Issues on which the PEAC will advise the FDA include:
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Although the FDA emphasizes greater consideration of issues such as patient preference information in its device clearance and approval determinations, the agency clearly states on its blog that such information will not trump scientific and clinical data when it comes to market authorization decisions:
“However, patient preference information will not be used to justify approval of unsafe or ineffective devices: if FDA determines the device would expose patients to an unreasonable or significant risk of illness or injury, or that the benefits do not outweigh the risks for a defined target population, FDA would not approve such a device.”
The US Food and Drug Administration’s revised Refuse to Accept (RTA) policy is now in effect.
The RTA policy involves an early review of 510(k) applications to determine whether they are “administratively complete,” or contain all materials necessary for the regulator to conduct a substantive review.
New guidance published by the US Food and Drug Administration advises manufacturers of “home use” medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.