FDA Extends Comment Period for Emerging Medical Device Signals Draft Guidance

January 28, 2016

On December 31, 2015, FDA released a draft guidance entitled “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’),” which stated its plans to take a more aggressive approach to reporting medical device safety warnings to the public.

When the draft guidance was initially published the FDA stated that anyone interested in providing feedback on the document would have until February 29, 2016 to do so. However, “due to the unanticipated high-level of interest from external stakeholders and the medical device community,” the Agency is extending that deadline. On Wednesday, January 27, FDA announced that interested persons will now have until March 29, 2016 to submit any comments, questions, or concerns on the draft guidance.

View our FDA News article for additional information on the contents of the draft guidance.

Are you in the process of developing a medical device? Do you have a device that needs FDA approval? We can help. Using our proprietary approach, we can help get your product through FDA cheaper, better, and faster. To learn more about our services and how we can help you, contact us today.


February 24, 2016

FDA Submissions for Interoperable Medical Devices – Comment Period Extended for Draft Guidance

Additional information on FDA’s recommendations for interoperable medical devices is available in our blog post entitled “A Closer Look at FDA’s Draft Guidance Regarding Premarket Submissions for...

October 28, 2021

FDA Revokes Emergency Use Authorization of IVD Device for COVID-19 Detection

On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization (EUA) for its TaqPath COVID-19 MS2 Combo Kit 2.0. Background On August 2, 2021, FDA issued an EUA...

August 28, 2015

FDA Extends Comment Period For Its “Request for Quality Metrics” Draft Guidance

Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...