By Jennifer D. Newberger – On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011. The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE). A HUD is a …
By Carmelina G. Allis – The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. 78 Fed. Reg. 4307 (Jan. 22, 2013). This rule finalizes a proposed rule issued on September 23, 2009. The new rule, …
Hyman, Phelps & McNamara, P.C. will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. Nor …
By Jeffrey K. Shapiro – FDA has enhanced authority over the sale, distribution and use of devices that the agency designates as “restricted.” 21 U.S.C. § 360j(e). FDA almost always designates Class III devices as “restricted devices” in premarket application (“PMA”) approval orders. 21 U.S.C. …
By Jennifer D. Newberger – On December 31, 2012, CDRH released three final guidance documents, the drafts of which were issued in the summer and fall of 2012. The quick finalization of these guidance documents is likely due to their fairly uncontroversial nature, since they are …
By Jennifer D. Newberger & Jeffrey N. Gibbs – A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions. For example, in the United Kingdom an organization …
By Carmelina G. Allis – Earlier this month, the IRS published final regulations and interim guidance on the excise tax imposed on the sale of certain medical devices intended for human use pursuant to the Health Care and Education Reconciliation Act of 2010 and the Patient Protection …
As we promised in an earlier post, we provide here a deeper analysis of the Second Circuit’s holding in United States v. Caronia and the context in which it should be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an associate with three to six years experience in medical device law and regulation to assist with a growing practice. Strong writing skills are required. Compensation is competitive and …
The ability to successfully obtain FDA approval is critical to the success of a medical device. However, sometimes even the most dedicated efforts fall flat when FDA says “No.” What then? What can you do if FDA says it believes there is not an adequate …
By Jennifer D. Newberger – On November 28, 2012, CDRH issued a report titled “Improvements in Device Review,” addressing progress in the Center since issuance of its “Plan of Action” in January 2011. The report states that since the Plan of Action, “the speed and predictability …
By Jennifer D. Newberger – Section 520(b) of the Federal Food, Drug, and Cosmetic Act ("FDC Act") exempts “custom devices” from the performance standards or premarket approval ("PMA") requirements of sections 514 or 515 if certain criteria are met. The Food and Drug Administration Safety and …
By Jennifer D. Newberger – FDA is amending its proposed rule to establish a unique device identification (“UDI”) system, published on July 10, 2012 (see our previous post here), to meet the requirements of section 614 of the Food and Drug Administration Safety and Innovation Act …
By Jennifer D. Newberger – CDRH recently announced that, as of November 1, 2012, the Office of Device Evaluation ("ODE") has been reorganized. There are two new divisions—the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices—and 12 new branches across all …
By Carmelina G. Allis – FDA has issued a draft guidance document to explain how FDA plans to implement the new eCopy program under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which was added by the Food and Drug Administration …
