By Melisa M. Moonan – FDA has granted stakeholders an additional 30 days to comment on its the December 31, 2015 draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” The new deadline for comments is March 29, 2016. We previously commented on …
By Allyson B. Mullen – On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule. The guidance is quick to …
By Melisa M. Moonan – It has come to our attention that FDA has initiated inspections at several hospitals in various parts of the country to assess compliance with User Facility Medical Device Reporting (MDR) obligations under section 519 of the Federal Food, Drug, and Cosmetic …
By Allyson B. Mullen – On New Year’s Eve, FDA gave an end of the year surprise to the device industry: the draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” FDA indicates that the purpose of the guidance is to provide information …
By Allyson B. Mullen – In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not …
Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro participated in a panel discussion at a recent Food and Drug Law Institute conference that focused on the regulation of digital health software. Mr. Shapiro’s talk emphasized the limits of FDA’s expertise and the need for caution …
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 …
