In recent years, FDA has sought to increase the patient perspective in its regulatory decision making. One way this is accomplished is through use of patient‑reported outcome (PRO) measures in clinical studies. PROs can assess concepts that are unobservable to clinicians and are only know …
FDA formally announced the Safer Technologies Program (STeP) in a December 2018 press release from then-FDA Commissioner Scott Gottlieb, M.D., and Director of CDRH Jeff Shuren, M.D. Details on the program were limited other than to say that the program would be designed to complement …
Since FDA announced in late 2016 that it would not finalize its laboratory developed test (LDT) guidances, it has become clear that any change to the LDT regulatory framework (at least during this administration) would need to come through a statutory change. The first such …
In the midst of the government shutdown and with its accompanying lull in new FDA documents, we thought it would be a good time to update our readers on some guidances that were issued late last year. Two such notable draft guidances were the, “Select …
On December 4, 2018, FDA issued a proposed rule that would govern the de novo classification process. After a comment period, it may be re‑issued as a final rule to take affect 90 days after publication. While we agree with FDA’s goal of creating greater …
The 510(k) pathway was first established in the Medical Device Amendments of 1976, and amended in the Safe Medical Devices Act of 1990. Since that time, the statutory language creating this pathway has remained largely unchanged. Yet, the program has morphed from one in which …
It’s been about two months since FDA issued its Technical Assistance (TA), and the buzz around FDA’s draft legislation has not died down. In fact, FDA has continued to promote the proposal, including a speech by Commissioner Gottlieb’s Chief of Staff, Lauren Silvas, in late …
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 …
