by Jennifer Newberger - Since September 1995, FDA and CMS have operated under an interagency agreement (IA) regarding Medicare coverage for investigational devices. That same month, CMS also published a rule that permitted Medicare coverage of certain devices with an approved investigational device exemption (IDE) in place. …
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 & Jeffrey N. Gibbs – Oh Medical Device Amendments how we love thee. This Saturday marks your 40th birthday. In light of this momentous occasion, we wanted to wish you a very happy birthday with a blog post all your own. In 1976, …
The American Conference Institute (“ACI”) is holding its fourth annual FDA Boot Camp – Medical Devices Edition on Thursday, July 21 to Friday, July 22, 2016 at the InterContinental Chicago Magnificent Mile, Chicago, IL. This year’s program has been revamped to provide both a “basic …
By McKenzie E. Cato* & Allyson B. Mullen – On May 16, FDA issued its final guidance document on postmarket surveillance of medical devices, “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act,” approximately five years after issuing the draft guidance. The …
By McKenzie E. Cato* & Allyson B. Mullen – On May 10, FDA issued the long-awaited draft guidance, “Technical Considerations for Additive Manufactured Devices.” In October 2014, FDA held a public workshop on AM devices, “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical …
The short answer to that question is “No,” says Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro in an article published in the March/April 2016 issue of the Food and Drug Law Institute’s Update Magazine. Mr. Shapiro examines the Department of Justice’s recent criminal prosecution of …
By Allyson B. Mullen – On April 1, FDA issued an updated draft guidance regarding the policies and procedures for Emergency Use Authorizations (EUAs). The EUA procedures cover all types of medical products including drugs and biologics (e.g., vaccines and therapeutics) and devices (e.g., personal protective …
By Allyson B. Mullen – For the past several years, a public-private stakeholder Planning Board has been evaluating the possibility of a new National Medical Device Evaluation System (NMDES). See our earlier posts on this initiative here and here. As discussed in our earlier posts, the NMDES is …
By Jennifer D. Newberger – The Federal Trade Commission (FTC) recently released a guidance titled “Mobile Health App Developers: FTC Best Practices,” intended to provide tips to developers about data security. FTC also released an accompanying on-line tool to assist developers in determining the federal laws …
By Jeffrey N. Gibbs & Allyson B. Mullen – Imagine that you were working at a device company and you received a letter today from FDA saying that FDA was “correcting” the FDA clearance you received nineteen (19 – that is not a typo) years ago. …
By Mark I. Schwartz – One of the pre-eminent rules in QSR and cGMP compliance is to document one’s activities. In the eyes of FDA, the “failure to document” is often equated with the failure to perform the underlying regulated activity. FDA takes this position principally …
By Melisa M. Moonan – On March 4, 2016, FDA published a Federal Register Notification titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” (March 2016 notification). This notification announces the establishment of a …
FDA regulatory requirements for products are heavily influenced by the product’s classification. FDA has developed procedures for determining whether a product should be regulated as a drug, device, or biologic. Understanding FDA’s procedures for determining jurisdiction is essential for companies that are seeking to market …
By Allyson B. Mullen – By In early February, Booz Allen Hamilton (“Booz Allen”) issued its Final Implementation Report assessing the actions taken by CDRH to address the firm’s earlier recommendations to improve the Center’s premarket review activities. We previously blogged on Booz Allen’s recommendations and …
