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September Regulatory Letter

Medical Device User Fee Amendments (MDUFA)
FDA announces fee rates and payment procedures for medical device user fees for fiscal year (FY) 2020. Read more.

Marketing Clearance of Diagnostic Ultrasound Systems
The FDA has issued its final guidance on marketing clearance of diagnostic ultrasound systems. Information can be found here.

CDRH Appeals Processes
Information on the appeals processes when a stakeholder disagrees with the CDRH's decision can be found here.

FDA Updates Recognized Census Standards Database
Read more about the updates here.

Software Precertification Program
Information on the FDA's mid-year update can be found here.

510(k) Third Party Review Program
Information can be found here.

Safe Importance Pharma Action Plan
Information can be found here.

Dental Device Premarket Submissions Webinar, October 2, 2019
Information on the FDA webinar on Dental Device Premarket Submissions can be found here.

UDI Conference
FDA UDI updates can be found here.

EU UDI Regulations and Updates
Moving from Harmonization to Acceptance of Differences in the EU information can be found here.

EU Post Market Clinical Data
The requirement to conduct PMCF is somewhat dependent on the justification prepared by the manufacturer in the clinical evaluation and risk management, typically the higher the classification/risk and where there are potentially unresolved issues the less likely the manufacturer would be able to prepare a justification not to conduct PMCF. How much PMCF is required is dependent on the manufacturer's justification/analysis. PMS is required for all devices and PSUR is required for most devices over class IIa.

Where it is required, the data on the manufacturers own device is the primary source of data to address the PMCF and PMS requirements. However, data from equivalent* devices is valuable and may be utilized in PMS plans to alleviate the need for original data from the manufacturer’s device. Data from equivalent* devices should be included in evaluations and PMS plans to be considered in the manufacturer's analysis as that data may point to significant aspects that the manufacturer should be addressing, in the context of the device being manufactured.

*Equivalent – is a key consideration.

Global Database for Accredited MS Certifications
View information on the new international accreditation forum database here.

The EC Waste Electrical and Electronic Equipment Directive
Information on the WEEE directive can be found here.

Adoption of HL-7 Standards
The SDCI agreed to the adoption of the HL-7 standards so that dental/medical records are compatible. Additional information can be found here.

ADA SCDI Standards on Informatics Meeting Recap
The ADA Standards Conference on Dental Informatics was recently held in San Francisco prior to the start of the 2019 ADA Annual Session. More than 100 dental professionals from industry, academia, the US government and military branches, research and the international community participated over the three-day conference. The conference updated a number of dental standards and worked on new modern definitions for dental standards in break out sessions. Topics included dental implants, infection control, teledentistry, harmonized international standards, and unique device identification. Attendees were surprised to learn many US manufacturers are being challenged to make the necessary changes to comply with the new European Medical device Directive so they can continue to sell their devices inside the European Union after the May 2020 deadlines. Due to a lack of notified bodies in Europe to do the risk management assessment and validate these devices under the new European Union regulations and standards, many US manufacturers may have to forgo selling their devices inside the EU, which is the second-largest market for US manufacturers after the US/North America. The SCDI is seeking additional industry representatives to participate in future meetings and help guide the new standards which directly impact US manufacturers. For more details on the SCDI, please contact Ms. Sharon Stanford from the ADA at

2020 ISO/TC 106 Dentistry Meeting
In 2020,  ADA and the Dental Trade Alliance, on behalf of the American National Standards Institute, will co-host the annual ISO/TC 106 meeting August 23-28 in San Diego, California. More than 350 delegates comprised of dental manufacturers, distributors, dentists, researchers, educators, government/regulatory agencies, and professional dental associations from over 30 member countries will attend this important meeting. Several 2020 sponsorship levels are available. Contact Fred Freedman (fredfreedman@dentaltradealliance) for more information.