Allyson B. Mullen

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 …

In July of last year, FDA released a draft guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies (see our post on the draft guidance here). On September 12, 2017, FDA released the final version of this guidance. The …

On September 6, 2017, FDA issued the final guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The final guidance can be found here. The document provides guidance regarding interoperable devices, which it defines as devices “that have the ability to exchange and …

The reduction in the rate of cervical cancer is one of the great success stories in public health.  The introduction of the Pap smear and human papillomavirus (HPV) testing has led to a significant reduction in the rate of cervical cancer.  However, there are still …

It appears that CDRH has now resumed issuing guidances after not issuing any in the first six months of the new administration. In late August and early September CDRH has issued several final guidances, including “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical …

FDA has historically classified accessories in one of two ways: (1) according to the parent device’s classification (either by express inclusion in the classification regulation or by clearance or approval of an accessory under the parent device’s classification regulation); or (2) by establishment of a separate …

FDA generated a great deal of the buzz a few weeks ago when it proposed exempting more than 1,000 Class II devices from the 510(k) requirements (see our earlier post here). Given the excitement, we thought it might be worth discussing what devices are no …

On March 14, in the Federal Register, FDA published a list of Class II devices that the agency proposes exempting from the 510(k) requirements. A copy of the Federal Register notice can be found here. As you may recall from our earlier post, Section 3054 …

In late November, FDA announced that it would not be finalizing the 2014 draft LDT Guidance.  The Agency had, however, done a significant amount of work regarding the draft guidance and evaluating the regulatory framework for lab tests.  In an effort to document the work …

Last week, FDA finalized the guidance document, “Postmarket Management of Cybersecurity in Medical Devices.” We previously blogged on the draft guidance released in early 2016 (here). The final guidance is similar to the draft issued in early 2016. There are, however, several noteworthy and significant edits. In …

In June 2016 CDRH released the draft guidance “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, Enforcement Decisions” (see our earlier post here). In the waning days of 2016, CDRH finalized the guidance. The final guidance is largely unchanged from the draft with …

Approximately one year ago, on New Years Eve, FDA surprised the device industry with a draft guidance on emerging postmarket device signals (see our post on the draft guidance here). On December 14, FDA issued the final guidance document: Public Notification of Emerging Postmarket Device …