More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. In 2016, the agency issued its definitive HF guidance to guide manufacturers through human factors engineering processes during the development of new medical devices, focusing …
Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products …
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 …
On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022). FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public …
A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive …
As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge …
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include …
Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) …
In our previous blog post, we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight. Two days after …
On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming …
It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here). While the potential mitigating impact of the “grandfathering” clause on laboratories currently …
Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code …
With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s …
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 …
In our last blog post, we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program. User Fees User …
