Medical Devices

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 …

By Melisa M. Moonan – After more than 600 comments and four and a half years since the draft guidance (“Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 21, 2011)) was published, FDA has released the final device human factors guidance, “Applying …

By Allyson B. Mullen – On January 26, FDA issued the draft guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” A copy of the draft guidance can be found here. The draft guidance addresses design and premarket issues related to the interoperability of devices, …

By Melisa M. Moonan – FDA has been flooding the zone with new guidance documents. Earlier this week, FDA finalized the human factors guidance, “Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff” (Feb. 3, 2016). At …

By Allyson B. Mullen – On January 15, FDA issued the draft guidance “Postmarket Management of Cybersecurity in Medical Devices.”  This draft guidance is the postmarket counterpart to the draft premarket guidance that FDA released in 2013, which we previously posted on here and here.  Without finalizing the …

By Allyson B. Mullen & Jeff N. Gibbs – Before the multiple feet of snow that the DC area recently received, CDRH had been creating its own storm of device guidance documents. One of the most recent ones is the final guidance “Submission and Review of …

By Melisa M. Moonan – FDA has granted stakeholders an additional 30 days to comment on its the December 31, 2015 draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” The new deadline for comments is March 29, 2016.   We previously commented on …

By Allyson B. Mullen – On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.  The guidance is quick to …

By Melisa M. Moonan – It has come to our attention that FDA has initiated inspections at several hospitals in various parts of the country to assess compliance with User Facility Medical Device Reporting (MDR) obligations under section 519 of the Federal Food, Drug, and Cosmetic …

By Allyson B. Mullen – On New Year’s Eve, FDA gave an end of the year surprise to the device industry: the draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” FDA indicates that the purpose of the guidance is to provide information …

By Allyson B. Mullen – In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not …

Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro participated in a panel discussion at a recent Food and Drug Law Institute conference that focused on the regulation of digital health software. Mr. Shapiro’s talk emphasized the limits of FDA’s expertise and the need for caution …