FDA Law Blog
NOVEMBER 29, 2023
Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change. The 510(k) summaries also include details on the planned modification protocols, including an impact assessment to address requirements for data management.
FDA Law Blog
MAY 8, 2023
Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
The Crime Report
APRIL 21, 2022
Gupta, the first physician to head the Office of National Drug Control Policy, will oversee the strategy, which also calls for: targeting the financial activities of transnational criminal organizations that manufacture and traffic illicit drugs in the United States; reducing the supply of illicit drugs smuggled across U.S.
FDA Law Blog
JUNE 12, 2022
The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . The increased number of reports would likely swamp FDA’s data systems, creating even more signal to noise than already exists.
FDA Law Blog
DECEMBER 12, 2022
If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device. Clinical Decision Support Software.
The Process Street
JANUARY 1, 2024
These solutions may incorporate elements of quality management as part of broader regulatory compliance frameworks, particularly in highly regulated industries like pharmaceuticals and healthcare. It offers a wide range of features tailored to meet the needs of various industries, including manufacturing, healthcare, life sciences, and more.
FDA Law Blog
JANUARY 5, 2023
It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
Expert insights. Personalized for you.
115 
Let's personalize your content