FDA will focus on interoperability for medical devices in 2015
The Center for Devices and Radiological Health at the Federal Drug Administration has released a list of its goals for the coming year. The list is an initial draft and the CDRH has invited the public to comment on it before finalization. One of the main priorities listed was a greater focus on giving the health care industry more information on the regulation of medical devices.
The publication also includes an official guide on enhancing medical device interoperability, patient access to health data and medical device decision support software. The CDRH's list of priorities has been published after an agreement to offer a clearer understanding of the guidance publication process.
CDRH publishes top priorities for 2015
According to FierceHealthIT, the publication focuses on two categories in the form of an A- and B-list. The A-list includes topics that are of the highest priority that the CDRH will be placing most of its time and effort on improving. The B-list is a secondary group of documents that the CDRH does not guarantee it will finalize or update in 2015. According to the publication, the CDRH has not completed the entire annual agenda of guidance documents in past years for several reasons. For example, the review of premarket submissions and postmarket issues are generally given greater priority and, therefore, divert the staff.
"Although resource constraints and new issues that emerge over the course of the year may preclude [the Center for Devices and Radiological Health] from issuing every guidance document on the A-list and B-list and may require that CDRH issue guidance documents not on the lists, the A-list and B-list are intended to provide helpful information about CDRH's current priorities for the upcoming fiscal year," the FDA said in its announcement.
The CDRH must also release a number of guidance documents every year, which it is unable to know about in advance. These documents could potentially involve health issues that have been identified for the first time. Special control guidance documents may also be included in these documents, which are required for the classification of brand-new devices.
The A-list
The A-list is comprised of the most essential topics that the CDRH will be working on first. The organization has asked industry stakeholders to assist it in determining which topics within the A-list are of highest concern. The agency is looking for input on the final guidance and draft topics of these six specific A-list categories.
The six topics include applying human factors and usability engineering to optimize medical device design, FDA notification and medical device reporting for laboratory developed tests, reprocessing medical devices in health care settings with a focus on validation methods and labeling, medical device decision support software, unique device identifier direct marking and FAQs, and informed consent concerning policy for observational data used to fulfill device requirements.
On the B-list, health care professionals will find medical device interoperability, use of symbols in labeling and patient access to information.
According to Modern Healthcare, the CDRH will receive feedback on published final guidance from years in the past through retrospective reviews. This will ensure that the FDA documents are as accurate as possible. The agency reported that it hopes to determine whether the final guidance that was issued in 1985, 1995, or 2005 should be revised or withdrawn. This will help the CDRH provide similar lists annually, as it intends to do through 2025. By 2025, the FDA and stakeholders will have closely examined all guidance older than 10 years.
The CDRH will issue lists of documents published 30, 20 and 10 years before that date. This way, all previous documents will have been opened and reviewed, starting with the list in 2016 that will include documents released in 1986, 1996 and 2006.
