FDA releases FY2016 planned guidance docs

The FDA’s Center for Devices and Radiological Health this week released a list of guidance documents it intends to publish for the next fiscal year.

The federal watchdog released 3 different lists of documents, including an A-list of 21 items it said it “fully intends to publish,” a B-list of 13 items the agency plans to publish “as resources permit” and a full list of all final guidance documents from the past 40 years.

Included in the 2016 A-list are topics ranging from final guidance for medical device accessories, UDI direct marketing, medical device reporting for manufacturers, policy for regulatory oversight of laboratory developed tests and 510(k) modifications and 3rd party review program information, according to an FDA press release.

The smaller B-list contains blood glucose monitoring and meter documentation, medical device interoperability info and other topics.

The CDRH invited “interested persons to submit comments on any or all of the guidance documents on the 3 lists,” including draft language for the topics, suggestions for new or different topics or documents, reasons such guidance is needed and information on relative priority and other data the FDA should consider on the topics.

The decision to publish the upcoming guidance documents was made during negotiations over the Medical Device User Fee Amendments in 2012.

The FDA said that its experience over the years has shown that it will likely not finish the entire list, and said the agency will rely on stakeholder feedback to prioritize the allocation of resources to complete specific topics from the list.

The post FDA releases FY2016 planned guidance docs appeared first on MassDevice.

from MassDevice http://ift.tt/1YJjxWq