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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

CPT code
17 Jul

FDA Update July 17, 2018

July 17, 2018 - 4:19 pm
FDA Updates

CPT Codes Current Procedural Terminology (CPT) codes are a proprietary 5-digit numeric coding system that is owned, managed, and maintained by the American Medical Association (AMA). They are used to describe office visits and medical and surgical procedures performed by physicians and other health care professionals. Decisions regarding the application for a new CPT code

22 Jun

FDA Update June 21, 2018

June 22, 2018 - 4:58 pm
FDA Updates

Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests. On June 15th, 2018 the FDA released a guidance attempt to standardize the way that in vitro diagnostic (IVD) tests are coded. This standardization was mainly created to assist the implementation of electronic health records (EHR) for the IVD tests. Laboratories commonly use a

19 Jun

FDA Update June 19, 2018

June 19, 2018 - 4:17 pm
FDA Updates

HCPCS Codes Rather than writing out the name of the diagnosis, medical device or surgical procedure on a claim form for payment by insurers, standardized code sets have been established so that providers, suppliers, Medicare and private insurers can convey information in a simple and consistent manner, especially placed on a claim form for billing

Jun

FDA Update June 18, 2018

June 19, 2018 - 2:45 pm
FDA Updates

FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder! This is an interesting proposal for medical device industry from the President’s administration to help push an end to the opioid crisis. The FDA issued an innovation challenge to create devices to prevent opioid abuse and treat those who are already addicted. Applications will

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