By Jennifer D. Newberger – FDA issued a proposed rule to amend its regulations on acceptance of data from medical device clinical studies. The primary proposed changes include: Requiring that clinical studies conducted outside the United States to support any submission to FDA, including a 510(k) or …
By Jennifer D. Newberger – The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to require certain medical device submissions to include, “if readily available – (A) a description of any pediatric subpopulations that suffer …
By Carmelina G. Allis – As reported in FTC Watch Issue No. 823 (Feb. 13, 2013), the Federal Trade Commission has plans to increase enforcement actions against mobile apps – including mobile medical apps. During a Consumer Protection Conference sponsored by the American Bar Association earlier …
By Jeffrey K. Shapiro – We are seeing the first fruits of a new device reclassification procedure added last summer to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The new procedure modifies Section 513(e) of the FDCA to make it easier for FDA to reclassify …
On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia. Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries. HP&M was quite pleased that …
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 …
