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 …
By Ricardo Carvajal – FDA announced a public workshop intended to help the agency gather information on the safety and effectiveness of medical devices that use nanotechnology. FDA posted questions on its website that focus on manufacturing, characterization, and biocompatibility issues of the sort that …
By Jamie K. Wolszon – FDA announced on August 19, 2010 in the Federal Register that the agency is reopening the comment period for comments related to FDA oversight of laboratory-developed tests ("LDTs"), and will now accept comments until September 15. The comment period had closed …
By Carrie S. Martin – On July 28, a district court in the State of Washington granted a motion for summary judgment in favor of Plaintiff which sought coverage of Medicare claims for a medical device. International Rehabilitative Sciences, Inc. v. Sebelius, No. C08-5442-RBL (W.D. …
By Carmelina G. Allis – Since September 2009, the Center for Devices and Radiological Health (“CDRH”) has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. This week, the 510(k) Working Group and the Task …
On August 4, 2010, the Food and Drug Law Institute (“FDLI”) will host a webinar, titled “FDA’s (Emerging) Oversight of Laboratory-Developed Tests.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will moderate the webinar and a panel of speakers that includes FDA’s Elizabeth A. Mansfield, …
By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA officials, at a July 19-20, 2010 workshop, stated that the agency intends to end the “exercise enforcement” authority over some laboratory-developed tests (“LDTs”). Put more plainly, FDA now plans to regulate some LDTs as medical …
By Jamie K. Wolszon – FDA is signaling that it is considering whether to fundamentally reshape how it regulates laboratories and laboratory-developed tests ("LDTs"). LDTs, which are diagnostic tests developed and performed by a laboratory, are widely used. For example, virtually every genetic test is …
