Government Manufacturing Medical Specialization 
Minnesota Academy of Family Physicians
MARCH 27, 2025
The bill passed by a voice vote and was referred to the State and Local Government Committee. 2413 ( Senator Mann ) creates a new assessment on hospitals to increase Medical Assistance reimbursement rates. 1878 ( Representative Keeler ) would cover traditional health care practices under Medical Assistance.
FDA Law
FEBRUARY 13, 2025
Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).
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Georgetown Pediatrics & Family Medicine
MAY 11, 2022
Always mix formula as directed by the manufacturer. I heard the government will be importing baby formula from other countries. If your child is older than 6 months of age and is usually on regular formula (not a specialty product for allergies or other special health needs), this may be an option. Is that safe?
FDA Law
OCTOBER 25, 2021
The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. FDCA § 513(f)(5).
FDA Law
MAY 7, 2025
Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.
FDA Law
MAY 3, 2021
Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §
FDA Law
MAY 3, 2021
Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §
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