Medical Devices

LDT Battle Lines Drawn: FDA Announces Jan. 8-9 Public Meeting on LDT Framework; Lab and Medical Groups Send Letter to FDA Commissioner Urging Notice-and-Comment Rulemaking; FDA and Patient Groups Advocate for LDT Framework on HillNovember 25th, 2014
By Jamie K. Wolszon – A battle is brewing between proponents and opponents of FDA’s plans to actively regulate Laboratory-Developed Tests (LDTs), with several developments involving both camps in the past two weeks. On the proponents’ side, on November 21, FDA announced that it will be …
DOJ Files Criminal Case Against Vascular Solutions, Inc. for Off-Label Device PromotionNovember 18th, 2014
By Allyson B. Mullen – Late last week, the Department of Justice ("DOJ") obtained criminal charges from a grand jury sitting in the United States District Court for the Western District of Texas against Vascular Solutions, Inc. ("VSI") and Howard Root, VSI’s CEO, for off-label promotion …
OIR Head Alberto Gutierrez Discusses Draft LDT Framework at Federal Laboratory Advisory Committee Meeting; Provides Additional Insights on Agency Plans to Regulate LDTsNovember 11th, 2014
By Jamie K. Wolszon & Jeffrey N. Gibbs – On November 6, Alberto Gutierrez, the head of the office in charge of regulating in vitro diagnostics at FDA’s Center for Devices and Radiological Health (CDRH), discussed the two Laboratory-Developed Test (LDT) draft guidances with members of …
CDRH Holds Webinar on Draft LDT Guidances – Highlights that Guidances Hold More Questions than AnswersOctober 28th, 2014
By Allyson B. Mullen & Jeff N. Gibbs – On October 23, 2014, CDRH held a webinar regarding the two Laboratory Developed Tests (LDT) draft Guidance Documents that were released on October 3 (previously blogged on here and here). The webinar began with a high-level description of …
FDA’s Hollow Medical Device Recall Guidance: Ending Not with A Bang But A WhimperOctober 23rd, 2014
By Jeffrey K. Shapiro – FDA has recently finalized the guidance document, now titled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” We were critical of the draft guidance, especially the proposal for a new, extra legal reporting requirement for device enhancements (see our previous post …
Medical Device Promotion on Social Media: Regulatory Considerations and Best PracticesOctober 12th, 2014
Hyman, Phelps & McNamara, P.C., jointly with Barton & Blank LLC, will present a webinar on Tuesday, October 21, 2014 from Noon – 1:30 PM (Eastern Standard Time), titled “Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices.” Social Media is increasingly being adopted …
510(k) Means Substantial Equivalence…Unless Your Device Has SoftwareOctober 7th, 2014
By Jennifer D. Newberger – In our previous posts (here and here) regarding FDA’s approach to cybersecurity in medical devices we noted that, while neither FDA nor industry was aware of any actual intentional, malevolent software breaches that led to patient harm, FDA seemed to be …
FDA Finalizes Custom Device Guidance DocumentOctober 2nd, 2014
By Jennifer D. Newberger – On September 24, 2014, FDA finalized its guidance document, “Custom Device Exemption,” which explains FDA’s interpretation of the new custom device requirements implemented as part of the Food and Drug Administration Safety and Innovation Act ("FDASIA"). We previously posted on the …
FDA Issues Draft LDT Guidance Documents; Provides 120-Day Comment Period and will Host October Public MeetingOctober 2nd, 2014
By Jamie K. Wolszon, Allyson B. Mullen & Jeffrey N. Gibbs – Following the July 31, 2014 notification to Congress (see prior post here), FDA wasted no time before formally issuing the draft laboratory-developed test (LDT) Guidance Documents. On October 3, 2014, just four days after …
Court of Appeals Holds that FDA Does Not Have Inherent Authority to Reclassify Devices by Rescinding a 510(k) ClearanceSeptember 28th, 2014
By Allyson B. Mullen – As we previously posted, in June 2011, ReGen Biologics, Inc. (“ReGen”), which was subsequently acquired by Ivy Sports Medicine, LLC (“Ivy”), sued FDA based upon the theory that FDA lacked authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to …
What Legal Authority Does FDA Have to Regulate Medical Device Promotion on Internet Social Media Platforms?September 25th, 2014
By Jeffrey K. Shapiro – FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and the advertising only of “restricted devices.” (21 U.S.C. §§ 352(a), 352(q) and (r).) FDA does have …
FDA’s 510(k) Review is a Powerful Regulatory Tool, But a Better Public 510(k) Database is Needed to Improve the Predictability of Substantial Equivalence ReviewSeptember 15th, 2014
FDA’s 510(k) review is based upon the concept of substantial equivalence. This approach has been much criticized, but in a new article published in the Food and Drug Law Journal and authored by Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro, Mr. Shapiro concludes …
FDA Finalizes Guidance Regarding IDE Decisions Without Pre-Decisional IDE ProcessSeptember 11th, 2014
By Jennifer D. Newberger – On August 19, 2014, FDA finalized its guidance document, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” which was issued in draft in June 2013. The final guidance is largely similar to the draft, with the exception of the pre-decisional IDE …
Court Vacates FDA’s Classification Decision (Again)September 9th, 2014
By Jennifer M. Thomas & Anne K. Walsh – French device maker PREVOR won another victory against FDA in litigation involving FDA’s interpretation of the statutory definition for “device.” The first suit, as readers may recall (see our previous post here), resulted in a finding from …
CDRH Seeks to Clarify UDI RequirementsAugust 27th, 2014
By Jennifer D. Newberger – On August 20, 2014, CDRH issued a guidance document, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1.” The purpose, according to the guidance, is to “provide[] clarification of key provisions of the UDI Rule.” We previously posted on the UDI rule …

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