Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Melisa M. C. Moonan has joined the firm as Of Counsel. Ms. Moonan advises clients on medical device regulatory issues. She joined the firm after close to six years as Associate Chief Counsel for Regulatory …
As combination products continue to increase in number and complexity, FDA has shifted its focus to developing more effective ways to review them. While FDA has strived to clarify regulatory requirements and coordinate product reviews among the various centers, it is often difficult to know …
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
By Jamie K. Wolszon & Jeffrey N. Gibbs – As kids around the country return to school, FDA also appears to be returning from a break—in this case a break from public enforcement-type activities related to laboratory-developed tests (LDTs)—with the issuance of a letter to Pathway …
By James C. Shehan & Andrew J. Hull – The U.S. Court of Appeals for the Eighth Circuit recently issued an opinion in the case of Lytle v. U.S. Department of Health and Human Services, Nos. 14-3715, 15-1214 (8th Cir. Aug. 21, 2015), affirming that private membership …
By Jamie K. Wolszon – As we have previously blogged on numerous occasions, FDA has released a framework for regulation of laboratory-developed tests (LDTs) that has sparked considerable controversy. The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant in …
By Jeffrey K. Shapiro & Jeffrey N. Gibbs – The Office of Combination Products (OCP) was established in 2002 to improve the agency’s handling of combination products and also drug versus device classification decisions. Unfortunately, it has become clear that more needs to be done. FDA’s …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
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, …
