FDA Law Blog
NOVEMBER 27, 2023
17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. Then, earlier this year, in April 2023, Gree USA, Inc., The government charged these individuals with conspiracy (18 U.S.C. §
FDA Law Blog
SEPTEMBER 20, 2021
When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.
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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.
FDA Law Blog
FEBRUARY 23, 2025
Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.
FDA Law Blog
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — 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.
FDA Law Blog
SEPTEMBER 19, 2023
That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.
FDA Law Blog
FEBRUARY 21, 2024
It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.
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