Medical Devices

User Facility MDR Inspections: Emerging Signal of an FDA Compliance Concern?January 13th, 2016
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 …
FDA Issues Draft Guidance for Notifying the Public of Emerging Postmarket Medical Device SignalsJanuary 7th, 2016
By Allyson B. Mullen – On New Year’s Eve, FDA gave an end of the year surprise to the device industry: the draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').”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 …
The New and Improved 510(k) RTA: Permitting FDA DiscretionJanuary 3rd, 2016
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Allyson B. Mullen – In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance).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 …
HP&M’s Jeff Shapiro Addresses FDA’s Role in Digital Health Regulation: Unclear and EvolvingDecember 20th, 2015
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 …
HP&M Announces Addition of New Of Counsel to its RanksDecember 15th, 2015
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 …
HP&M’s Jeff Shapiro to Speak at FDLI Combination Products WorkshopNovember 24th, 2015
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 …
A Long Overdue Revision to the Intended Use RegulationOctober 18th, 2015
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 …
Back from Break: FDA Issues Letter to Pathway Genomics for Cancer Screening LDT; Proposed Legislative Alternatives to FDA Framework Continue to EmergeSeptember 29th, 2015
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 …
Velvet Ropes Can’t Stop the FDA: Effort to Defeat FDA Jurisdiction Based on Club Membership Is Unceremoniously BouncedSeptember 2nd, 2015
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 …
Molecular Pathologist Group Proposes Legislative Solution to Modernize CLIA, Including CMS/Third-Party Premarket Review, as Substitute for FDA’s LDT FrameworkAugust 14th, 2015
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 …
Combination Products Reform Bill Is A Good Start, But Its Provisions Need StrengtheningAugust 6th, 2015
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 …
Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations BillsJuly 24th, 2015
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 …
Not All Devices are Created Equal: UDI Direct MarkingJune 29th, 2015
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 …
FDA to Weigh Risks and Benefits in Approving Investigational Device ExemptionsJune 23rd, 2015
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 …
Enforcing The “Least Burdensome” Requirement for Premarket Review of DevicesJune 22nd, 2015
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 …

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