On February 20, 2024, FDA issued a letter to the medical device industry (link) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. Unfortunately, the letter provides little new information to guide industry conduct. While …
As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in late December. We previously blogged on the draft guidance (here) and on FDA’s broader framework for Digital Health Technologies (DHT) (here and …
For more than three decades, FDA has claimed that the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here). In this post, we summarize the purported basis …
Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. Such data may be needed to demonstrate substantial equivalence to a previously-marketed predicate device or, less frequently, to show …
On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: …
Following up on our first post discussing Digital Health Technologies (DHTs) (here), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital …
As part of FDA’s Prescription Drug User Fee Act (PDUFA) VII goals published in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (PDUFA Goal Letter), which we blogged about here, FDA included a goal for enhancing use of digital health technologies (DHT) …
It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2nd …
As we discussed in our prior post, the electronic Submission Template And Resource (eSTAR) template will take getting used to in terms of form. It is also going to take some getting used to in terms of process. As most in the device industry know, …
Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k). With 18 years’ experience, we have developed a pretty good system for preparing 510(k) …
For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be …
As was introduced in our recent blog post summarizing the 2022 MedTech conference (here), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot (see announcement attributed …
FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). We have followed it over the last five years, with blog posts here, here, here, …
FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 4.3 requires generally that manufacturing of a …
It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here. The final guidance with …
