The third-party 510(k) review process was an emphasis in the most recent user fee negotiations and statutory changes under the FDA Reauthorization Act of 2017 (FDARA). This process has been criticized in the past for being restrictive, ineffective, and not beneficial for applicants. On January …
The title of this blog post should tell you everything you need to know about the proposed appeal regulations announced last week by CDRH (found here). On January 17, CDRH proposed regulations specific to the device appeal process for both 517A decisions as well as …
A week before Christmas, CDRH issued a revised draft of the Replacement Reagent policy. When finalized, the revised draft guidance will replace the 2003 final guidance. According to FDA, the revised guidance “is intended to update and provide clarity on” the existing policy. FDA has …
On December 20, FDA issued a new, draft guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways.” This guidance is the latest chapter in the years-long, and still on-going, story of accessory classification. As you may recall, Congress and FDA have both been working …
While many were on vacation and preparing to celebrate the New Year, CDRH was announcing yet another pilot program. You may recall FDA recently announced its Digital Health Software Pre-Cert Pilot Program and its Premarket Approval Application Critical to Quality Pilot Program. The latest pilot …
Section 513 of the Federal Food, Drug, and Cosmetic Act requires FDA to consider the least burdensome means of evaluating device safety and effectiveness for Class III devices and substantial equivalence for devices requiring 510(k) clearance. Despite this legal requirement, the device industry’s position has …
On December 5, 2017, FDA issued a final guidance: Technical Considerations for Additive Manufactured Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Additive Manufacturing (AM) is “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to …
On December 18, FDA released its draft guidance, “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” This is the latest guidance from the Agency on the relationship between in vitro diagnostic (IVD) products and therapeutic products. You will recall that the Centers jointly issued the …
On November 29, 2017, CDRH issued two draft guidances regarding CLIA Waiver requests: “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1998 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” (CLIA Waiver Guidance) and “Recommendations for Dual 510(k) and CLIA Waiver …
On October 30, CDRH issued the Final Guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (the “De Novo Guidance”). This is a final version of the 2014 draft by the same name (see our earlier blog post here). On the same day, …
On October 30, CDRH finalized the guidance entitled, “Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request”. This is the final version of the guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” issued in June 2016 (see our blog post on …
On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a …
The 21st Century Cures Act (Cures), signed into law in December 2016, established a program to provide priority review and management attention for breakthrough devices. We discussed the new section of the law in our earlier post on Cures (here). The law required FDA to …
Our April 16th blog post regarding 510(k) exemptions (here) garnered a lot of comments from our readers. So we thought it was worth a second post. As you will recall, the .9 limitation says that a device of the generic type in a 510(k)‑exempt classification regulation …
Getting an early jump on winter, between September 29 and October 2, CDRH issued a blizzard of new guidance documents. All eleven of these guidances were issued based on commitments from MDUFA IV. These guidances consist of: four guidances regarding user fees for each type of …
