By Allyson B. Mullen – On April 22, 2015, FDA released a draft guidance regarding use of clinical data generated outside of the U.S. (OUS) in medical device premarket submissions. A copy of the draft guidance can be found here. FDA states in the guidance that it …
By Allyson B. Mullen & Jeff N. Gibbs – As we have previously blogged on numerous times (for example, here and here), FDA has released a framework for regulation of laboratory developed tests (LDTs). FDA’s proposed framework has sparked much controversy, receiving support from diagnostic test …
By Allyson B. Mullen – On April 13, CDRH released the final guidance document for “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” We previously blogged on the draft guidance …
By Kurt R. Karst – It’s not all that often that we see the Patent and Trademark Office (“PTO”) dismiss or deny a request to extend the term of a patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do …
By Allyson B. Mullen – On March 17, 2015, CDRH released the final guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The draft guidance was issued in May 2011 and is now being finalized on the heels of highly publicized outbreaks …
By Allyson B. Mullen – In 2012, CDRH initiated an action plan to strengthen the medical device surveillance system (we previously reported on this plan here). As part of this initiative, a multi-stakeholder Planning Board was created with the purpose of “envisioning an MDS with the …
By Kurt R. Karst – Amidst concern that the 2013 sequester could make a repeat appearance and reduce both FDA’s budget from Congress and industry-financed user fees to the Agency, Representatives Anna Eshoo (D-CA) and Leonard Lance (R-NJ) have introduced legislation to exempt FDA user fees …
By Jamie K. Wolszon – Amidst the winter storms that have struck the East Coast this January and February, there has been, and will continue to be, a flurry of developments related to FDA efforts to actively regulate Laboratory-Developed Tests (LDTs). Those developments include a White …
By James E. Valentine* & Anne Marie Murphy – The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to …
By Jennifer D. Newberger – On February 9, less than a year after issuing the draft, FDA issued a final guidance document confirming its exercise of enforcement discretion with respect to medical device data systems (MDDS), medical image storage devices, and medical image communications devices. In …
By Jennifer D. Newberger – The question of what constitutes an accessory has never been well answered. In a December 1996 guidance document, Medical Device Quality Systems Manual: A Small Entity Compliance Guide, FDA said that accessory devices are devices “packaged, labeled, and distributed separately to a …
By Jennifer D. Newberger – FDA has historically taken the position that products intended to benefit a user’s overall health and wellness, and that did not make claims about disease prevention, treatment, mitigation, or cure, would not be regulated as medical devices. For example, in 1995, …
By Jeffrey K. Shapiro – FDA has always allowed companies to transfer 510(k) clearances without obtaining new clearance. Indeed, this blogger provided a short primer on the topic 15 years ago. However, this administrative practice has long been shrouded in mystery, because FDA has never published …
By Jeffrey N. Gibbs & Allyson B. Mullen – A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’s Jeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics …
By Jamie K. Wolszon & Jeffrey N. Gibbs – The House Energy & Commerce Committee, which has jurisdiction over FDA, has issued a “white paper” announcing that as part of its efforts to prepare a draft discussion legislative package in early 2015 related to the overall …
