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
- Internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections
- Mutual Recognition Agreement with the EU to recognize drug inspections conducted by foreign regulatory authorities that meet U.S. requirements
- Modernized structure of our field organization to improve inspection operations
- Guidance documents on quality issues
- Inspections classifications database on inspections of manufacturing facilities
- Concept of Operations agreement for quicker resolution of quality standards
- Advanced manufacturing practices, such as continuous manufacturing, for consistent and dependable manufacturing
- Grants to three research institutions on pioneering technology more widely
New 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