Consolidated Appropriations Act, 2022

Medcrypt launches new FDA Cybersecurity Readiness Services to prepare medical device manufacturers for upcoming changes to regulations

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星期三, 八月 9, 2023
RTA, Safety, Omnibus spending bill, Act, Policy, Federal Food, Drug, and Cosmetic Act, Quality, SAN, Royal Commission into Aged Care Quality and Safety, Estar, Consolidated Appropriations Act, 2022, FDA, MDM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Letter, FD, Food, Risk management, Medical device

SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness Services" empowering medical device manufacturers (MDMs) to confidently navigate the U.S. Food and Drug Administration's (FDA) Refuse to Accept (RTA) policy as well as the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023.

Key Points: 
  • SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Medcrypt, Inc. , the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness Services" empowering medical device manufacturers (MDMs) to confidently navigate the U.S. Food and Drug Administration's (FDA) Refuse to Accept (RTA) policy as well as the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023 .
  • "We developed the FDA Cybersecurity Readiness Services to address the growing demand from medical device manufacturers seeking guidance through the complex and evolving submission process.
  • Interested in ensuring your medical devices comply with FDA cybersecurity expectations (both requirements per the Act and recommendations per cybersecurity guidance)?
  • Inquire with Medcrypt to learn more about our FDA Cybersecurity Readiness Services, designed to guide medical device manufacturers through the new 510(k) eSTAR submission requirement and the cybersecurity Refuse to Accept (RTA) policy and streamline the path to regulatory approval.

Aridis’ AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation

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星期三, 七月 12, 2023
China Biologic Products, Biologics license application, Drug development, Food and Drug Administration Safety and Innovation Act, Innovation Act, QIDP, CAP, Infection, Omnibus spending bill, S, AMR, Staphylococcus, GAIN, Patient, Immunoglobulin G, VAP, Mab, Consolidated Appropriations Act, 2022, LOS, ICU, Saleh al Aridi, HAP, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Pneumonia, Food, Pharmaceutical industry, FDASIA

"Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.

Key Points: 
  • "Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.
  • This sought-after designation positions our AR-301 program extremely well as we continue to advance it through a confirmatory Phase 3 trial and license application."
  • AR-301 specifically targets S. aureus alpha-toxin, which has been implicated in the pathogenesis of pneumonia caused by S. aureus bacteria.
  • Aridis received positive feedback from the FDA in May 2023 on the Company's proposed single confirmatory Phase 3 study of AR-301.

Cybeats Announces License Agreement with Starfish Medical, Canada's Largest Contract Medical Device Design, Development and Contract Manufacturer

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星期一, 五月 22, 2023
Agreement, Regulation of tobacco by the U.S. Food and Drug Administration, CSE, TSX Venture Exchange, Medical device, CYBT, Marketing, RTA, Food, Omnibus spending bill, Disclosure, Starfish, Risk assessment, SBOM, Consolidated Appropriations Act, 2022, Person, Omnibus, Federal Food, Drug, and Cosmetic Act, Gold standard, GSM, Good, FDA, MDM, FD

Cybeats SBOM Studio delivers comprehensive software supply chain intelligence technology, empowering StarFish to effectively manage Software Bill of Materials ("SBOM") and proactively address cyber risks in their medical device projects.

Key Points: 
  • Cybeats SBOM Studio delivers comprehensive software supply chain intelligence technology, empowering StarFish to effectively manage Software Bill of Materials ("SBOM") and proactively address cyber risks in their medical device projects.
  • This recent contract with a medical device firm underscores the growing expertise in the healthcare security industry vertical and increasing demand for SBOM solutions within the industry.
  • This section mandates that Medical Device Manufacturers ("MDM") provide a SBOM for their devices' commercial, open-source, and off-the-shelf software components.
  • Cybeats, already serving one of the largest global MDMs, is in trial evaluations and late-stage contract negotiations with several other leading MDMs worldwide.

New report: 2022 was record-breaking year for U.S. product recalls

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星期四, 三月 2, 2023
United States Department of Agriculture, FTC, FDA, Federal Trade Commission, PFAS, Policy, Car, Consolidated Appropriations Act, 2022, Food, Omnibus spending bill, U.S. Consumer Product Safety Commission, Marketing, Estar, CPSC, Food and Drug Administration, United States Environmental Protection Agency, EVS, USDA, EPA, Medical device, Automotive industry, Pharmaceutical industry

MEMPHIS, Tenn., March 2, 2023 /PRNewswire/ -- For the second consecutive year, more than 1 billion units of food, drugs, medical devices, automobiles, and consumer products were recalled in the U.S. According to Sedgwick's latest state of the nation recall index report, 2022 was a record-breaking year for the number of units recalled, reaching nearly 1.5 billion. With regulatory scrutiny continuing to increase, 2023 may shape up to be another 1 billion unit year, requiring businesses across industries to remain vigilant on matters of product safety and recall preparedness.

Key Points: 
  • Automotive recalls decreased 12.6% in 2022 compared to 2021.
  • While the number of consumer product recalls increased by nearly a third (31.2%) in 2022 over 2021, the number of units recalled almost halved (45.4%), from 42.8 million in 2021 to 23.4 million in 2022.
  • FDA food recalls experienced a 700.6% increase in the number of units impacted in 2022.
  • Recall events in the medical device industry increased by 8.8% in 2022, up from 837 events in 2021 to 911.