By Carmelina G. Allis – A billhas been introduced in the U.S. Senate, the “Medical Device Regulatory Improvement Act” (S. 1700) to amend the least burdensome and conflicts of interest provisions in Sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, …
By Jennifer D. Newberger – On October 14, 2011, Representative Brian Bilbray (R-CA) introduced H.R. 3203, the “Novel Device Regulatory Relief Act of 2011.” This bill intends to amend section 513(f) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process for …
By Jeffrey K. Shapiro – A medical device manufacturer in most cases is legally required to obtain 510(k) clearance or premarket application (“PMA”) approval from the Food and Drug Administration’s (“FDA”) prior to commercial distribution. Premarket reviews are conducted under the auspices of the Office of …
By Jennifer D. Newberger – On September 30, 2011, FDA announced the issuance of a Draft Guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation), intended to update and streamline the de novo review process. The de novo review process, formally known as Evaluation of …
By Jamie K. Wolszon – On August 31, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted comments to FDA’s June 1 Draft Guidance regarding research use only (“RUO”) products (see our previous posts here and here). Although HPM supports many parts of the Draft Guidance, in its comments, …
The Practising Law Institute ("PLI") has released a new Medical Devices Law and Regulation Answer Book 2011–12, edited by Suzan Onel (K&L Gates LLP) and Karen M. Becker (Becker & Associates Consultants). This Q&A guide is intended to orient and guide those new to the …
By Carmelina G. Allis - Below is a summary of some of the key issues discussed during FDA’s September 12 and 13, 2011, public meeting on the recently issued draft guidance document for mobile med apps. During the meeting, FDA also requested input on how to …
By Carmelina G. Allis – If you thought you’ve had enough trying to figure out whether FDA regulates your mobile app, watch out for the FTC. The FTC has brought its first case targeting health claims related to mobile medical apps. The mobile apps, sold in Apple’s …
By Jennifer D. Newberger – On August 15, 2011, FDA released two Draft Guidances: “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices.” Each is discussed in turn below. Factors to Consider when Making …
By Jennifer D. Newberger – On July 29, 2011, the Institute of Medicine ("IOM") released its long-awaited report, “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.” Both industry and FDA were likely surprised by the IOM’s recommendation: do away with the …
By Jennifer D. Newberger – On July 27, 2011, the Center for Devices and Radiological Health ("CDRH") announced the issuance of a Draft Guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” When finalized, this guidance document will …
By Carmelina G. Allis – The FDA’s “Draft Guidance on Mobile Medical Applications” is applicable to software products (or “mobile apps”) intended for use on mobile platforms that are handheld in nature, such as, for example, the iPhone® and Android® phones. “Mobile medical apps” are defined …
By Jamie K. Wolszon – FDA announced earlier this week the publication of a much-anticipated draft guidance on in vitro companion diagnostic devices. In the draft guidance, FDA stakes out a policy position that if safe and effective use of a therapeutic depends on a diagnostic, …
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
By Kurt R. Karst & Jeffrey K. Shapiro – French company PREVOR has filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that PREVOR’s Diphoterine® Skin Wash (“DSW”) is a drug-device combination product with a “drug” primary mode of …
