MDUFA IV User-Fee Reauthorization Provisions	Authorizes FDA to collect $999.5m, plus inflation, in medical device user fees from FY 2018 through FY 2022, and implements multiple reforms that will allow the agency to meet commitments it made in negotiations with industry groups in 2016, including adjustments to the third-party 510(k) review program, a move to pre-market electronic submissions and a piloted approach to streamlined review of sponsor conformance to standards. (Also see "User-Fee Facts: 10 Key Medtech Details From US FDA Agreements" - Medtech Insight, 11 May, 2017.)
Risk-Based Inspections For Devices	Medtech facilities will be inspected on a risk-based schedule in the US and abroad.
Improvements To Inspections Process For Device Establishments	Device inspection processes at home and abroad will be updated to be made uniform. Advance warning to facility owners will apply, and FDA must draft a guidance within 18 months of FDARA enactment for communications between agency staff and facility owners on how inspections must take place. (Also see "New Bill Aims To Bring Consistency, Transparency To US FDA Inspections" - Medtech Insight, 16 February, 2017.)
Certificates To Foreign Governments For Devices	If FDA denies a request for an export certificate by a device manufacturer, the agency must provide the basis for the denial in writing; the firm denied certification has the opportunity for review of the decision; and FDA must issue a guidance on how the certification process is carried out within one year of the bill's passage.
Facilitating International Harmonization	FDA may recognize third-party auditing organizations to conduct inspections of US device establishments, just as the auditing organizations are recognized for foreign plant inspections.
Fostering Innovation In Medical Imaging (Contrast Agents)	FDA may clear or approve, under 510(k), PMA, and de novo authorities, new indications of contrast agents for medical-imaging devices as long as the agents are not used in different concentration, route of administration or anatomical region from its original approved labeling. Gives the FDA's device center, rather than the drug center, primary jurisdiction in reviewing new contrast agent indications in these circumstances. (Also see "House Bill Clarifies CDRH Lead For New Imaging Indications For Devices Using Contrast" - Medtech Insight, 17 April, 2017.)
Risk-Based Classification of Accessories	Establishes a new risk-based process for classifying or reclassifying device accessories separately from the parent device. For accessories that have been granted marketing authorization as part of a submission for a parent device, the agency must propose a list of accessories each year that it says are suitable for class I designation; and if there is a request for class II designation, FDA must respond to the request within 85 days.
Real-World Post-Market Surveillance Pilot Projects	Within one year of enactment of FDARA, FDA shall initiate one or more pilot projects for devices cleared or approved under 510(k), PMA, or de novo regulations that are designed to generate timely safety and active post-market surveillance data on the device, and using electronic health data including claims, patient survey or any other data the agency designates. The pilots can continue or be expanded to increase voluntary participation or allow for public recommendations for any devices prioritized. A report on the project(s) including how real world evidence was used, is due Jan. 21, 2021, following a review by an independent third party.
Regulation Of Over-The-Counter Hearing Aids	Hearing aids to be regulated are defined as for adults age 18 and older to compensate for perceived mild to moderate hearing loss. No personal sound-amplification products (PSAPs) meet the definition. FDA has three years after FDARA enactment to propose OTC hearing aid rules requiring the aids be safe and effective; establishing output limits for the devices; and including appropriate labeling barring use for those under age 18, providing information on how to report adverse events, and advising consumers to consult first with a licensed health-care practitioner before purchase. A final guidance required, updating the draft guidance of Nov. 7, 2013, "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products," due the same date as final OTC hearing-aid regulation.
Report On Servicing Of Devices	FDA has 270 days after FDARA enactment to post on its website a report about medical device servicing, including the status of and findings of a proposed rule called "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices by Third-Party Entities and Original Equipment Manufacturers (OEMs)." Report has to say how FDA will track adverse events caused by servicing errors, and how other regulatory bodies such as the Joint Commission regulate third-party servicers and OEMs, among other requirements.

House-Senate Versions Married In Latest User-Fee Bill, Up For July 12 House Debate

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