The Center for Devices and Radiological Health (CDRH) at the FDA will be focusing on providing the industry with more information on the regulation of medical devices in the coming year, including drafting or finalizing guidance on improving medical device interoperability, medical device decision support software, unique device identifiers, and patient access to device information. As part of an agreement to provide more transparency into the guidance publication process, CDRH has published its initial list of goals and invites public comment on its intended priorities.
The list includes two grades of topics: those of higher priority upon which CDRH will focus most of its efforts, and a secondary group of documents that may or may not be finalized or updated within the next year. “Our experience over the years has shown that there are many reasons why CDRH does not complete the entire annual agenda of guidance documents it undertakes,” the website says. “Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or post-market problems.”
“In addition, CDRH is required each year to issue a number of guidance documents we cannot know about in advance. These may involve newly identified public health issues as well as special control guidance documents that are necessary for the classification of de novo devices.”
To help establish which topics are of highest concern, CDRH is seeking input from industry stakeholders on final guidance and draft guidance topics that include the following from the “A-list”:
• Applying Human Factors & Usability Engineering to Optimize Medical Device Design;
• FDA Notification and Medical Device Reporting for Laboratory Developed Tests;
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling;
• Medical Device Decision Support Software;
• Unique Device Identifier (UDI) Direct Marking and FAQs; and
• Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements.
And additional topics from the “B-list”:
• Medical Device Interoperability;
• Patient Access to Information; and
• Use of Symbols in Labeling.
CDRH will also be conducting retrospective reviews of previously published final guidance to ensure that the FDA documents are as accurate as possible. “CDRH would appreciate external feedback on whether any final guidance that issued in 1985, 1995, or 2005 should be revised or withdrawn,” the agency says. “CDRH intends to provide such lists annually through fiscal year 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidance older than 10 years.” Each year, CDRH will publish lists of documents published thirty (30), twenty (20), and ten (10) years prior to that date, so that the list in 2016 will include documents released in 1986, 1996, 2006, and so on until all previous documents have been opened for public review.
REFERENCE: EHR Intelligence; 09 JAN 2015; Jennifer Bresnick