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 …
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Medical Devices
- FDA Issues Draft Guidance Describing Benefit-Risk Factors Taken Into Account In Post-Market Compliance DecisionsJune 22nd, 2016
- FDA Issues Final Rule Permitting Use of Symbols on Device LabelingJune 16th, 2016
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 …
- FDA Issues Draft Guidance Regarding Dissemination of Patient Information from Medical DevicesJune 14th, 2016
By Allyson B. Mullen – On June 10, FDA issued the draft guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” At a mere six pages long, this guidance is not tipping the scales by any means, but its few short pages contain some important …
- FDA, CMS, IDEs, an IA, and an MOU…Hopefully Lead to YES, You’re Covered!June 9th, 2016
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. …
- Join Our Team – HP&M Seeks Junior to Mid-Level AssociateJune 6th, 2016
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 …
- Happy 40th Birthday Medical Device Amendments – You’re Officially Over-the-HillMay 26th, 2016
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, …
- ACI’s FDA Boot Camp – Medical Devices EditionMay 25th, 2016
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 …
- FDA Finalizes Postmarket Device Surveillance GuidanceMay 17th, 2016
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 …
- FDA Issues Much Anticipated Draft Guidance on Additive Manufactured (“3D-Printed”) DevicesMay 11th, 2016
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 …
- Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?April 26th, 2016
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 …
- FDA Issues Updated Draft Guidance for Emergency Use Authorizations: Emphasis on IVDs and Government AgenciesApril 12th, 2016
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 …
- Another Year, Another Report on National Medical Device Evaluation System but Still Few DetailsApril 11th, 2016
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 …
- FTC Issues Tool Intended to Assess Laws Governing Mobile Health AppsApril 8th, 2016
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 …
- 510(k) Clearance “Corrected” 19 Years after Original ClearanceApril 1st, 2016
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. …
- QSR/cGMP Compliance, the Failure to Document, and “A Few Good Men”March 21st, 2016
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 …