By Jennifer D. Newberger – Perhaps the most interesting thing about the recently released draft guidance, Deciding When to Submit a 510(k) for a Software Change to an Existing Device, is its mere existence.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By Jennifer D. Newberger, Anne K. Walsh & Jeffrey N. Gibbs – The recent issuance of FDA’s draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, which, when finalized, will replace the guidance of the same name issued in January …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 The draft guidance, on which we posted here, was issued in January 2015.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 …
By Jennifer D. Newberger – With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content …
By McKenzie E. Cato* and Jeff N. Gibbs – As we reported previously (see previous post here), FDA has issued two long-awaited draft guidances on next generation sequencing (NGS) diagnostic tests. The first, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro …
McKenzie E. Cato* and Allyson B. Mullen Many device companies struggle to ensure that the patients enrolled in their clinical studies are representative of the sex, age, race, and ethnic make-up of the U.S. population. In part, this task is difficult because device clinical studies are …
By Allyson B. Mullen – On June 16, FDA issued the final guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.’” This final guidance replaces the draft guidance issued on April 23, 2013. Biocompatibility …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas of food and drug law and regulation to assist with a growing practice. Strong verbal …
By Allyson B. Mullen – It is an open secret that at some point in every device company’s life one or more of its devices will likely be out of compliance with the Federal Food, Drug, and Cosmetic Act. That is because the regulatory scheme is …
By Allyson B. Mullen – Symbols have been an accepted part of device labeling outside of the U.S. for many years. In the U.S., however, symbols alone have not been permitted on medical device labeling, with the exception of guidance allowing use of “Rx Only.” To …
