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B. Mullen & Jeff N. Gibbs – On October 23, 2014, CDRH held a webinar regarding the two Laboratory Developed Tests (LDT) draft Guidance Documents that were released on October 3 (previously blogged on here and here).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 We were critical of the draft guidance, especially the proposal for a new, extra legal reporting requirement for device enhancements (see our previous post …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 …
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 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 …
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 …
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 …
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 …
By Jennifer D. Newberger – On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of …
By Jennifer D. Newberger — We previously posted about CDRH’s guidance on the appeals process contained in the Food and Drug Administration Safety and Innovation Act (FDASIA), and its issuance of a draft Q&A discussing section 517A. Section 517A imposed timeframes for appeal decisions that were …
