By Jennifer M. Thomas – Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the …
For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending. Yet, questions about how to apply this policy still remain. In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions …
By Jeffrey K. Shapiro – In 1976, FDA first began comprehensive regulation of medical devices. Among the new statutory provisions, there was one requiring persons registering with FDA to list all marketed devices. Each device on the list was to be accompanied by a copy of …
By Anne K. Walsh & Andrew J. Hull – A problematic decision from the Ninth Circuit appears to impermissibly grant FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. We hope other courts recognize this …
By McKenzie E. Cato* & Allyson B. Mullen – In May 2015, FDA issued a draft guidance addressing how FDA might consider patient preference information (PPI) in review of premarket approval applications (PMA), humanitarian device exemption (HDE) applications, and de novo requests; the types of data …
By Allyson B. Mullen – As our blog readers know, the 510(k) Third Party Review Program has been a bit of a flop in terms of utilization and clearance times (see our previous post here). In Fiscal Years 2013, 2014, and 2015, only 3.2%, 2.2%, and 2.3% …
By Anne K. Walsh & Andrew J. Hull – FDA announced in an August 31, 2016 notification (“Notification”) that it will convene a public hearing to address its authority to regulate communications regarding unapproved uses of approved or cleared drugs and medical devices. The public hearing …
By Jennifer D. Newberger – Perhaps the most interesting thing about the recently released draft guidance, Deciding When to Submit a 510(k) for a Software Change to an Existing Device, is its mere existence. Historically, all changes to 510(k)-cleared devices were analyzed under the same guidance, …
By Jennifer D. Newberger – The long-awaited update to the 1997 guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, was released in draft on August 8. In contrast to its 39-page predecessor, this 73-page document is impressive in the level …
By Jennifer D. Newberger – Though the UDI compliance date for Class II devices is just over one month away, one key question remains unanswered: are private label distributors “labelers” for purposes of the UDI rule? This turns out to be much less clear-cut than it …
By Jennifer D. Newberger – On August 11, 2016, the Office of Combination Products (OCP) announced a “pre-RFD” process. A Request for Designation (RFD) is the formal process for seeking FDA’s assessment of product classification, for example, determining whether a product should be regulated as a …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …
By Jennifer D. Newberger, Anne K. Walsh & Jeffrey N. Gibbs – The recent issuance of FDA’s draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, which, when finalized, will replace the guidance of the same name issued in January …
This spring marked the 40th Anniversary of the Medical Device Amendments. Thanks to significant technological advancements there is no sign of slowing down for medical device regulatory developments. Devices were a prominent focus at this year’s Food and Drug Law Institute’s Annual Conference. Sessions included …
By Jennifer D. Newberger – On July 29, 2016, FDA finalized its guidance document, General Wellness: Policy for Low Risk Devices. The draft guidance, on which we posted here, was issued in January 2015. The final guidance is nearly identical to the draft, while providing a …
