News and Views: Global Efforts for Product Quality, FDA-Payor Program, Uncertainty in Benefit-Risk  Determinations, 510(k) “Quik” Program – Drug and Device Digest


Global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA framework to help assure that all drug products meet the same high-quality standards, regardless of where they’re manufactured, brand or generic products, prescription or over-the-counter drugs


Capture.JPGNew Program with Payors Aims to Accelerate Patient Access to Medical Devices

FDA recognizes importance of working collaboratively with payor community to streamline the path from FDA market authorization to payor coverage and reimbursement.

Parallel Review Program: Piloted in 2011, fully adopted in 2016. Mechanism for decreasing time between FDA’s approval of a pre-market medical device application and CMS national coverage determination

  • Early feedback from the FDA and CMS on design of pivotal clinical trial in Pre-Submission Mtg
  • 75 inquiries into the process and 36 formal applications to participate in Parallel Review

Private Payor Program: Launched in 2016

  • Receive feedback from  FDA and other non-governmental health technology assessors/payors during the Pre-Submission mtg
  • Participants:  BlueCross BlueShield Association, Duke Evidence Synthesis Group, ECRI Institute, Humana, Kaiser Permanente, and the National Institute for Health and Care Excellence (NICE)
  • New Additions: CareFirst BlueCross BlueShield and United Health Group
  • 4 Pre-Submission mtgs with private payors
  • Program continues to gain momentum receiving new inquiries weekly

Payor engagement strategy particularly beneficial for manufacturers creating new and innovative devices 



Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

Principles in guidance apply to FDA’s consideration of uncertainty in benefit-risk determinations for PMAs, De Novo requests, and HDE applications. Factors include:

  • Extent of probable benefits including the type, magnitude, probability, duration, frequency
  • Extent of probable risks including the severity, type, number, rates, probability,  duration
  • Extent of uncertainty regarding the benefit-risk profile of alternative treatments
  • Patients’ perspective on appropriate uncertainty about probable benefits and risks
  • Extent of the public health need (e.g., seriousness of the illness)
  • Feasibility of generating extensive clinical evidence premarket
  • Ability to reduce or resolve remaining uncertainty  postmarket
  • Likely effectiveness of postmarket mitigations, such as labeling
  • Type of decision being made
  • Probable benefits of earlier patient access to the device

Examples provided



Quality in 510(k) “Quik” Review Program Pilot

Launch of Quality in 510(k) (“Quik”) Review Program pilot

  • Simplify completion of  premarket notification (510(k)) submission for sertain moderate risk devices
  • Use free eSubmitter software for review efficiency
  • Not be subject to a Refuse to Accept (RTA) review; FDA interactive review and decision within 60 days
  • Does not change any requirements for the determination of substantial equivalence


Image credits: FDA, CMS




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