By Jennifer D. Newberger – The question of what constitutes an accessory has never been well answered. In a December 1996 guidance document, Medical Device Quality Systems Manual: A Small Entity Compliance Guide, FDA said that accessory devices are devices “packaged, labeled, and distributed separately to a …
By Jennifer D. Newberger – FDA has historically taken the position that products intended to benefit a user’s overall health and wellness, and that did not make claims about disease prevention, treatment, mitigation, or cure, would not be regulated as medical devices. For example, in 1995, …
By Jeffrey K. Shapiro – FDA has always allowed companies to transfer 510(k) clearances without obtaining new clearance. Indeed, this blogger provided a short primer on the topic 15 years ago. However, this administrative practice has long been shrouded in mystery, because FDA has never published …
By Jeffrey N. Gibbs & Allyson B. Mullen – A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’s Jeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics …
By Jamie K. Wolszon & Jeffrey N. Gibbs – The House Energy & Commerce Committee, which has jurisdiction over FDA, has issued a “white paper” announcing that as part of its efforts to prepare a draft discussion legislative package in early 2015 related to the overall …
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 …
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 …
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 …
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B. Mullen & Jeff N. Gibbs – On October 23, 2014, CDRH held a webinar regarding the two Laboratory Developed Tests (LDT) draft Guidance Documents that were released on October 3 (previously blogged on here and here).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 …
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 …
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 …
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 …
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 …
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 …
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 …
