FDA regulations

FDA classifies transcutaneous electrical nerve stimulators for congestion relief as class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

FDA reclassifies non-invasive bone growth stimulators (product codes LOF and LPQ) from class III to class II devices, requiring premarket notification and establishing special controls for safety and effectiveness.

FDA determines REVIA (naltrexone hydrochloride) 50mg tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory standards.

FDA classifies manual surgical instruments for orthopedic implant patient selection as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden on manufacturers.

FDA approved AREXVY respiratory syncytial virus vaccine under the rare pediatric disease priority review voucher program on June 7, 2024, enabling the sponsor to redeem a voucher for expedited review of a future application.

FDA amends animal drug regulations to reflect application actions for new animal drugs during October through December 2025 and improve regulatory accuracy and readability.

FDA approves MNEXSPIKE (COVID-19 Vaccine, mRNA) as a rare pediatric disease product eligible for priority review voucher redemption as of May 30, 2025.

FDA publishes draft guidance (VICH GL8(R1)) for stability testing of medicated premixes intended for animal feed incorporation, developed through international harmonization standards.

FDA requests 60-day public comment period on information collection requirements for its prescription drug importation regulation under the Paperwork Reduction Act.

FDA determines the regulatory review period for UNLOXCYT patent extension eligibility under patent term extension law for human biological products.

AYCO FARMS INC recalls 8,302 cartons of fresh cantaloupes due to potential Salmonella contamination distributed across PA, FL, CA, and NY in this Class I recall.

MEI YU CHENG DA TRADING INC recalls 29 cases of DADI NONGFU dried salt chili vegetables distributed in NY, PA, and FL due to banned cyclamate sweetener in a Class III recall.

Beckman Coulter recalls 3 boxes of MicroScan Neg Multidrug Resistant MIC test panels distributed to Poland due to manufacturing defects that may cause incorrect in vitro diagnostic results.

Spacelabs Healthcare recalls 1,790 multi-parameter command modules (Model 91496) due to circuit board defects that may cause inaccurate cardiac output measurements and delayed patient care.

Molded Products Inc. voluntarily recalls 26,900 units of MPC-130 See Luer Cap Set nationwide due to threaded sleeve detachment risk, classified as Class II medical device recall.