By Jennifer D. Newberger – Devices intended to be reprocessed and used on more than one patient are required to be directly marked with a unique device identifier (UDI). 21 C.F.R. § 801.45. If, however, the direct marking “would interfere with the safety or effectiveness of the …
By Jennifer D. Newberger – To further its efforts to balance risks and benefits with respect to approving medical devices through the premarket approval (PMA) pathway or utilizing the de novo classification process, FDA has now issued a draft guidance, "Factors to Consider When Making Benefit-Risk …
By Jeffrey K. Shapiro – Last week, Senators Richard Burr and Al Franken introduced legislation aimed at easing the burdens of the Food and Drug Administration’s (FDA) review of devices. The bill is called “The FDA Device Accountability Act” (FDAA). A copy of the press …
By Jeffrey K. Shapiro – In 1987, an FDA official testified that 20 hours were spent on average to review a 510(k) submission. Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. …
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the …
By Jennifer D. Newberger – In March 2012, FDA issued a guidance document, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. As we discussed in our blog post on that guidance, one important discussion in that guidance had …
By Jennifer D. Newberger – As part of its 2014-2015 Strategic Priorities, the Center for Devices and Radiological Health (CDRH) committed to assuring the “appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices.” By December 31, …
By Allyson B. Mullen – On April 22, 2015, FDA released a draft guidance regarding use of clinical data generated outside of the U.S. (OUS) in medical device premarket submissions. A copy of the draft guidance can be found here.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 …
