nick-otto-articles

31. FDA Issues UDI Guidance Tailored For Small Device Makers 8/18/2014

    The FDA recently issued guidance advising small medtech companies on how to comply with the agency’s unique device identification (UDI) system, which requires device makers to label their products with codes aimed at improving product recalls, organizing electronic health records, and deterring counterfeiting efforts.
     

32. Report Notes Uptick In Medtech Employment 8/18/2014

    Employment within the medical device industry remained steady in 2013, with most device-makers experiencing increases in their workforce.

33. 3D Printing Added To FDA's Experiential Learning Program 8/13/2014

    The FDA recently announced its intentions to add a new general training program component to its Experiential Learning Program (ELP).

34. FDA Finalizes Guidance For Home-Use Medical Devices 8/11/2014

    The FDA recently released guidance for manufacturers on design considerations for medical devices intended for use at home to address the unique risks associated with the domestic environment.

35. FDA Seeks Industry Feedback On Labeling Burdens 8/8/2014

    The FDA is seeking industry feedback on the recordkeeping burdens medical device-makers face in maintaining labels.

36. FDA's Regulation Of Laboratory Developed Tests On The Horizon 8/4/2014

    The FDA recently announced that it is going to begin regulating medical laboratory testing, including companion diagnostics and laboratory developed tests (LDTs). In the statement, the agency stated that tests used to make important treatment decisions must be inspected to provide “accurate, consistent and reliable results.”

37. FDA Finalizes 510(k) Substantial Equivalence Guidance 7/31/2014

    The FDA recently released final guidance addressing key issues in the agency’s 510(k) clearance program, describing in detail the critical decision points in the 510(k) review process.

38. European Commission Seeks Input On Safety Of Nanomaterials Used In Medical Devices 7/30/2014

    The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has opened public consultation on the use of nanomaterials in medical devices.

39. Industry Leaders Address Revival Of U.S. Device Innovation 7/29/2014

    Recently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.

40. Proposed Changes To Sunshine Act Could Mean Added Costs For Device-Makers 7/28/2014

    The Centers for Medicare & Medicaid Services (CMS) recently proposed four changes to the Physician Payment Sunshine Act’s transparency rules that could result in additional costs for medical device manufacturers.