nick-otto-articles

41. New FDA Curriculum To Educate Innovators On Approval Process 7/23/2014

    The FDA is hoping to help industry better navigate the labyrinth of its medical device regulatory approval process by offering a free, university-level regulatory training program.

42. FDA Rejects Petition Of Controversial Transvaginal Mesh Products 7/21/2014

    The FDA has rejected a call for a total ban on transvaginal mesh products filed by consumer advocacy group Public Citizen.

43. FDA Issues Fresh Draft Guidance On 510(k) Benefit-Risk Review 7/21/2014

    Manufacturers submitting 510(k)s may now need to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device.

44. India's CDSCO Clarifies Device Trial Requirements, Categories 7/17/2014

    India’s Central Drugs Standard Control Organization (CDSCO) issued notices last week clarifying several categories and regulatory requirements for devices that would be regulated under the same requirements that drugs face via India’s Drugs and Cosmetics Act of 1940.

45. FDA Downgrades Headache Treatment Devices To Class II 7/16/2014

    The FDA has issued a final reclassification notice that eases regulatory requirements for manufacturers of neurostimulators used to treat headaches, which should speed the process of getting those devices to market.

46. House Subcommittee Pushes 'Patent Troll' Bill Forward 7/15/2014

    A House of Representatives panel has approved a draft of a bill that would rein in abusive patent demand letters.

47. FDA Looks To Further Develop Pediatric Safety, Efficacy 7/14/2014

    It’s been a busy few weeks for the FDA, and the agency recently released another forward-thinking plan on ways it plans to enhance the safety and study of products used in treating pediatric populations.

48. Senators Urge Approval Of FDA Laboratory-Developed Test Draft Guidance 7/11/2014

    Five Democratic senators are urging the U.S. Office of Management and Budget (OMB) to approve draft guidance developed by the FDA to better regulate laboratory tests used in the detection of common ailments.

49. FDA Five-Year Plan Focuses On Globalization, Safety 7/8/2014

    The FDA has laid out its strategic priorities for the next five years, including plans to increase its inspection and enforcement activities with its international counterparts.

50. Are Unannounced Audits The New Norm For EU Devicemakers? 7/3/2014

    The European Employment, Social Policy, Health, and Consumer Affairs (EPSCO) Council recently discussed the actions taken on behalf of the European Commission and member states with regard to the current level of confidence consumers have with the industry following the breast implant scandal by the now defunct Poly Implant Prothèse (PIP).