: 516-482-9001

News and Info

Scanning of the Reimbursement Landscape
27 Nov

Scanning of the Reimbursement Landscape

November 27, 2018 - 6:16 pm
FDA Updates, Industry News

Environmental scanning of the reimbursement landscape, also known as reimbursement assessment, is a process that collects information on trends and priorities that impact or influence your medical device’s success in the marketplace. Performing an initial reimbursement assessment is important because it provides a baseline analysis of potential reimbursement gaps, risks, and opportunities for new medical

21 Nov

FDA Update November 21, 2018 PHARMA Industry

November 21, 2018 - 3:28 pm
FDA Updates

REMINDER: Annual Blanket No Changes Certification of DRUG Product Listing This is a reminder regarding the FDA’s recent drug certification requirements.  Under the FDA’s new drug certification requirements, products that were not initially listed or updated during 2018 must be certified that their previously submitted drug listing information has not been changed.  The product listing certification

31 Oct

CAN IT BE – The MEDICAL INDUSTRY IS OPERATING IN COMPLIANCE?

October 31, 2018 - 4:03 pm
Industry Articles

The FDA has issued a total of 24 warning letters to the medical device industry for the fiscal year 2018. That is two WLs per month. WOW, that is AMAZING. With hundreds of inspections being conducted by the FDA, worldwide, such low number of warning letters would make one believe that the MEDICAL DEVICE industry

Reinburssement strategy
29 Oct

Reimbursement Strategy

October 29, 2018 - 10:30 am
FDA Updates

No matter how hard it is to manufacture a safe and efficacious medical device, it is not going to generate the anticipated revenues unless it can be properly reimbursed by insurers. While considerable time, effort and expense are required to successfully carry out a reimbursement strategy, such a plan is essential to assuring a favorable

01 Oct

Reimbursement for Medical Devices

October 1, 2018 - 3:16 pm
FDA Updates

Common Mistakes Medical Device Manufacturers Make Today’s economic healthcare environment has created overwhelming reimbursement challenges. The situation is frequently complex and the stakes are high. Companies need not wait for FDA approval before addressing reimbursement issues which they should begin early in the medical device’s development. Putting reimbursement on the back burner until after launch

27 Sep

FDA Update September 27, 2018

September 27, 2018 - 9:26 pm
FDA Updates

FDA Food Facility Registration Renewal Period!! Next week, on October 1, 2018, the FDA’s Biennial Registration Renewal Period begins for 2018.  Food facilities are required to register with the FDA and renew their registrations between October 1 and December 31 every year as specified under section 415 of the FD&C Act. Food facilities that were

14 Sep

FDA Update September 14, 2018

September 14, 2018 - 3:22 pm
FDA Updates

Quality in 510(k) “Quik” Review Program Pilot. On September 6th, the FDA launched the Quality in 510(k) “Quick” Review Program pilot.  This program is expected to help manufacturers simplify the premarket notification submission process for certain moderate-risk medical devices.  The pilot will also evaluate whether the FDA’s eSubmitter software will result in more organized submissions,

20 Aug

FDA Update August 8, 2018

August 20, 2018 - 5:25 pm
FDA Updates

Medical Devices; Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments. As required by the FDA Reauthorization Act of 2017 (FDARA), the FDA has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and

02 Aug

EU Regulatory Update

August 2, 2018 - 8:24 pm
Industry News

EU Approves New In-Vitro Diagnostic Device Regulation; Transition period has begun. On April 5, 2017, the European Parliament approved the new In-Vitro Diagnostic Device Regulation.  This is the first major change in the IVD regulations. There is a five-year transition period following the formal publication of the IVDR for the industry to become compliant with

Aug

What is Evidence-based Medicine and Why Should I Care?

August 2, 2018 - 5:48 pm
FDA Updates

Until recently, medical decisions were highly subjective, being called “clinical judgment”, “the art of medicine” or “in my experience”. To gain knowledge, practitioners got their information from reading textbooks whose information is over 3 years old and a few journal articles. To keep up to date, reading the vast amount of journal articles published in

Archives