By Jamie K. Wolszon – Trade reports recently indicated that FDA intended to issue by the end of May a draft guidance outlining its policy for “Research Use Only” (“RUO”) and “Investigational Use Only” (“IUO”) products such as reagents and instruments. Last week FDA posted on …
By Robert A. Dormer – In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out” process. …
By Jamie K. Wolszon – ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a …
By Carmelina G. Allis – Earlier this month, FDA updated the 1998 guidance document regarding changes to a PMA device that may or may not qualify for a 30-Day Notice. This updated document provides new examples of manufacturing changes that may be submitted under a 30-Day …
Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will be giving the state of the industry address at Q1 Productions’ 2nd Annual Clinical & Regulatory Strategies for Combination Products, which is slated to take place in Baltimore, Maryland from July 11-12, 2011. The potential benefit …
By Carmelina G. Allis – A March 24, 2011 warning letter from FDA cites a rarely invoked provision in the Investigational Device Exemption (“IDE”) regulations. It is not clear whether this warning letter is an outlier or a harbinger of more aggressive inspections by the Division …
By Alan M. Kirschenbaum – Today drug and device manufacturers and other stakeholders had an opportunity to provide comments to CMS during an Open Door Forum teleconference on how the physician payment sunshine provisions of the Patient Protection and Affordable Care Act ("ACA") should be …
By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. ("Matrixx") for allegedly violating § 10(b) of the Securities Exchange Act and Exchange Commission Rule 10b-5. As …
By Jennifer D. Newberger – One of the tasks of the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) is to make recommendations that will result in cost savings and/or improvements in program efficiency and effectiveness. Unfortunately, as we are …
By Kurt R. Karst – Last week, Judge Richard Leon of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear candle advocates after the Agency issued about 15 Warning Letters …
By Jennifer B. Davis – Three and a half years ago, Congress directed FDA to identify lower risk devices for reporting malfunction MDRs on a quarterly basis in summary form. FDA still has not done so. Specifically, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), …
By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health (“CDRH”) has proposed the “Innovation Pathway Program” for breakthrough medical devices. CDRH says it will review these products in 150 days or less, which the agency claims is nearly half the review time of …
By Jeffrey K. Shapiro – Yesterday FDA announced that the Center for Devices and Radiological Health (“CDRH”) intends to take 25 actions to improve the 510(k) program in 2011. The full action plan and remarks from CDRH Center Director Jeffrey Shuren, M.D., J.D. can be accessed …
Hyman, Phelps & McNamara, P.C.'s Jeff Shapiro published an article in this month's MD&DI magazine - What Happens to Medical Device Reports Once They Reach FDA? In the article, he summarizes a Office of Inspector General Report finding that FDA has not used medical device reporting …
By Jeffrey K. Shapiro – A group of nine U.S. Senators has sent a letter to FDA expressing concern over potential changes to the 510(k) medical device clearance program. The letter is similar to a November 2010 letter from Minnesota lawmakers and an October 2010 letter …
