FDA recently released further updates to the Customer Collaboration Portal (“CCP”). Readers of the blog will know that I am a HUGE fan of the CCP (see our earlier posts here and here). It has made filing of all premarket submissions much easier by facilitating …
As we noted in our previous blog post available here, Quidel’s Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set’s De Novo, now opens the door for follow-on 510(k) submissions that declare this product as their predicate, if the product meets …
We were listening to a radio interview last week with Lina Khan, the Chair of the Federal Trade Commission (“FTC”). In the interview, Khan spoke about the Commission’s efforts to regulate geolocation data trackers so that they don’t abuse their abilities. The risks she described …
FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device …
Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber …
On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C. will present a webinar entitled “Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” John will provide participants with a greater understanding of new guidance implications, as well as recent …
South Korea has made significant achievements over the years in the biohealth industry, establishing the world’s second-largest biopharmaceutical manufacturing capacity. South Korea continues to drive the effort in the biohealth industry, which will lead to more Korean players in the U.S. market. The South Korean government …
The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Such codes need to be placed on device labels and packages to allow devices to be easily identified …
Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MQSA was passed to ensure, among other things, that nationwide, patients …
On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Those who use eSubmitter will notice changes in the …
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, …
A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here). The proposed rule was published on February 23, 2022 and was first …
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) …
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 …
