It is common for uncertainty to arise during the premarket review of novel medical devices. How CDRH has handled that uncertainty in the context of its benefit-risk assessment has generally been somewhat of a black box. While FDA has issued numerous benefit-risk guidances, the Agency …
FDA recently issued its final rule for the Voluntary Malfunction Summary Program, which permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements set forth in section 519 …
Comment one, comment all! As part of FDA’s ongoing effort to clarify the classification for medical device accessories (see our previous posts here, here, and here), on August 17, 2018, FDA issued a notification requesting comments on a proposed list of accessories that FDA believes …
One of the most painful consequences of a bad inspection at a U.S. facility is FDA’s resulting refusal to issue certificates to foreign governments (CFGs) until the issues are resolved. CFGs are quite often a requirement to renew licenses and permits to sell in various …
By far one of CDRH’s greatest recent successes has been the Pre-Submission program. In our experience, more companies have been engaging early and often with the Agency to discuss product-related regulatory issues and questions. Under the Food and Drug Administration Reauthorization Act and the MDUFA …
On June 5, 2018, FDA published a notice in the federal register finalizing the 510(k) exemption for several devices. The proposed list for 510(k) exemption was published last November and included two new devices that had been granted marketing authorization through the de novo process …
On May 31, 2018, CDRH issued the draft guidance, “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.” The draft guidance is intended to provide an outline of the type of information to be included in non-clinical bench …
On April 13, 2018, FDA issued the final guidance documents “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases” (hereinafter the NGS Guidance, available here) and …
On April 12, 2018, the three FDA Centers jointly issued the draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination” (draft available here). The draft guidance outlines a process for obtaining FDA’s feedback regarding whether an investigational IVD …
On January 30, 2018, FDA issued revised guidance documents: Refuse to Accept Policy for 510(k)s and PMAs (here and here). These revised guidances may have gone unnoticed by many as there was no federal register notice announcing or discussing the revisions from the policy in …
On February 15, FDA’s Office of Combination Products (OCP) announced the draft guidance, “How to Prepare a Pre-Request for Designation (Pre-RFD).” Don’t let the name fool you though. Unlike the similarly named Pre-Submission, a Pre-RFD does not need to precede a formal RFD. A Pre-RFD …
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 …
