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 …
By Jeffrey K. Shapiro & Carmelina G. Allis – FDA’s review of 510(k) program continues to cause concern in Congress. On November 24, 2010, the Minnesota delegation, including unlikely collaborators Senator Al Franken and Representative Michele Bachmann, sent a letter to Dr. Hamburg asking “FDA to review …
By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health is conducting a usability study of the establishment registration and device listing database. The objective is to make the database easier to use. They are looking for feedback from those who regularly use the …
By Carmelina G. Allis – We previously reported on FDA’s August 2010 publication of a report recommending changes to the 510(k) program. We briefly discussed the proposed changes, and raised concerns with some of the agency’s recommendations because of their potential negative effect on the medical …
By Jeffrey K. Shapiro – The de novo classification procedure was added to the FD&C Act in 1997 to create a middle pathway between the 510(k) process and full blown premarket application ("PMA") approval. It is intended for devices that utilize novel technologies that are not …
By Ricardo Carvajal – Section 10(b) of the Exchange Act and Securities and Exchange Commission (“SEC”) Rule 10b-5 prohibits “any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person, in connection with the purchase or …
