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24 Jan

FDA UPDATE January 22, 2020

January 24, 2020 - 2:49 pm
FDA Updates

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

15 Jan

Reimbursement Can Make or Break a Device

January 15, 2020 - 6:21 pm
Newsletter

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

11 Dec

Reimbursement Tips for Medical Device Companies

December 11, 2019 - 7:39 pm
Newsletter

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

20 Nov

FDA UPDATE November 20 2019

November 20, 2019 - 8:02 pm
FDA Updates

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

12 Nov

Medicare’s Regulations Regarding Coverage

November 12, 2019 - 7:53 pm
Newsletter

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

08 Nov

FDA Update November 8, 2019

November 8, 2019 - 5:08 pm
FDA Updates

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

16 Oct

How to Construct a Value-Driven Dossier to Present to Payers for Coverage

October 16, 2019 - 4:41 pm
Newsletter

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

11 Sep

Reimbursement Stakeholders

September 11, 2019 - 8:57 pm
Newsletter

It is extremely important that those who work in a medical device company know the various players they must deal with to achieve success. A provider is a person or institution who directly provides medical, surgical or health services and who bills an insurance company for services rendered and is paid for them in the

10 Sep

FDA Update September 10, 2019

September 10, 2019 - 6:41 pm
FDA Updates

FDA Announces Cooperative Agreement to Implement Produce Safety Rule The U.S. Food and Drug Administration (FDA) announced a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) that was established to help carry out the produce safety rule as part of the FDA’s ongoing efforts to implement the FDA Food Safety Modernization

09 Sep

FDA Update September 9, 2019

September 9, 2019 - 1:37 pm
FDA Updates

Federal judge enters consent against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx for drug, device, and dietary supplement violations. A federal judge in Tennessee ordered a consent decree of permanent injunctions against two Tennessee-based companies, Basic Reset and Biogenyx. The permanent injunction prohibits the two companies and their owners from distributing

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