The FDA has released its annual Medical Device Quality System Data report concerning Form 483 and Warning Letter Citations, and there’s some good news to be found in the official report. Specifically, for the first time in four years the agency has reported a decline in the overall number of warning letters issued to medical device companies. Only 144...

The Office of Generic Drugs (OGD) at FDA released two guidance documents in September 2014 as part of their efforts to develop “enhanced refusal to receive standards for ANDAs and other related submissions by end of year 1 of the program…” per the Generic Drug User Fee Amendments of 2012 (GDUFA). The two guidances are: Guidance for Industry “ANDA Submissions...

A new guidance document intended to assist small medical device manufacturers is now available from the FDA. ‘Unique Device Identification System: Small Entity Compliance Guide” consists of a series of recommendations designed to help companies handle the requirements associated with the UDI system and Global Unique Device Identification Database (GUDID)....

On August 26, 2014, FDA published a draft Guidance for Industry entitled “Controlled Correspondence Related to Generic Drug Development”.  FDA defines Controlled Correspondence as follows: “A correspondence submitted to the Agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic...

The FDA is moving forward with a series of upgrades to its IT infrastructure that will have a direct impact on how medical device companies submit and interact with 510(k) submissions as well as participate in the de novo process. The changes are intended to make communication between the FDA and manufacturers more efficient, as well as improve the...

Data security is a common rallying point for medical device manufacturers, especially those brave enough to enter the churning medical device app space. The ability of major corporations to protect the data of their users was highlighted by a spate of well-publicized hacks, including illegal access to information held by Apple’s iCloud online storage...