This week the commissioner of the FDA released a new update regarding the effects and response of the FDA in relation to the Coronavirus. The FDA has emphasized that they are taking a multi-faceted approach to this public health emergency. This approach includes facilitating efforts to diagnose, treat, and prevent the disease; surveilling the medical
This past week, Costco Wholesale Corporation became the first approved participant in the FSMA Voluntary Qualified Importer Program (VQIP). This program is a voluntary, fee-based program that allows importers to receive expedited review and importation of human and animal foods into the United States under the FSMA. Costco has shown management of safety and security
Many of our clients want to understand what it will take to get a successful launch of your device. Here is some insight to what you should be looking for to assure you give your technology a chance of getting your market to notice. Medical marketing can be a daunting task. For the start-up to
FDA Reclassification Updates Earlier this week, the FDA issued a final order which reclassified several families of medical devices. These devices include certain radiological medical image analyzer such as Computer-Assisted Detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices. These devices have been reclassified from
In recent years, reimbursement by insurers has trumped FDA regulatory approval as the medical device industry’s biggest concern and remains at the forefront of stakeholders’ minds. To prevent reimbursement issues from impacting financing goals, device manufacturers must develop a well-planned reimbursement strategy in parallel with their regulatory and clinical strategies in the early phases of
These days, it often seems the main struggle for medical device companies is not earning FDA regulatory approval, but rather, securing reimbursement and payment from CMS and private payers. Here are some tips for you to consider. First, develop a reimbursement strategy early on in your product’s development by receiving recommendations from a consulting reimbursement
FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs The FDA issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple cGMP regulation violations at
The FDA’s regulations state that isolated case reports, random experience, reports lacking enough detail to permit scientific evaluation, and unsubstantiated opinions do not constitute valid scientific evidence. More device manufacturers are recognizing the importance of considering Medicare coverage and reimbursement principles during the development of their new technologies. By adopting long- and short-term strategies that
FDA Will Continue Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA. The FDA will be continuing its enforcement discretion policy for compliance with certain FDA Food Safety Modernization Act (FSMA) supply-chain program requirements applicable to receiving facilities that are co-manufacturers. “Co-manufacturing” is when one party (the brand owner) arranges for a second party (the
Good clinical studies are the most important piece of data to have to present in a dossier (portfolio) to the payer. These studies are published as full-text in peer-reviewed journals, with study subjects that represent the beneficiaries covered by the payer, outcomes that show improvements in health benefits of their members and representing a large
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