Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
59
result(s) for
"Rathi, Vinay"
Sort by:
Modernizing the FDA’s 510(k) Pathway
More than 90% of FDA-reviewed devices enter the market by means of the 510(k) pathway. In September 2019, the FDA finalized reforms to the pathway. But further steps could better support protection of patients and public health.
Journal Article
Automatic Medicare Coverage for New Medical Technologies — Here We Go Again
Automatic Medicare Coverage for New Technologies Congress is considering bills that would substantially expand Medicare coverage of certain products. The legislation could undermine CMS’s authority to implement evidence-based coverage policies.
Journal Article
Regulation of Over-the-Counter Hearing Aids — Deafening Silence from the FDA
In August 2020, the FDA missed a statutory deadline to release rules governing over-the-counter hearing aids. It’s unclear when the agency will fulfill its legal obligation to establish regulations that are expected to increase treatment access for millions of people.
Journal Article
Privately Negotiated Facility Fees at Ambulatory Surgery Centers and Hospitals
Private negotiated facility fees at hospitals are on average double the ambulatory surgery center facility fees for common outpatient procedures.Private negotiated facility fees at hospitals are on average double the ambulatory surgery center facility fees for common outpatient procedures.
Journal Article
Medical Device User Fee Reauthorization — Back to Basics or Looking Ahead?
Medical Device User Fee ReauthorizationUser fees are vital to FDA operations. But user-fee legislation has focused on expediting premarketing review rather than understanding device risks and benefits throughout the product life cycle.
Journal Article
Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?
CMS recently finalized a rule that could substantially alter Medicare-coverage decisions for certain new medical devices. The rule is intended to expedite coverage, but it would undermine Medicare’s authority to consider the clinical evidence supporting device adoption.
Journal Article