U.S. Medical Devices Regulatory Update – July to September, 2020

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”¹

Issued September 4, 2020, this guidance is an update to the final guidance issued in 2016, providing FDA’s current thinking and recommendations on the use of risk assessment to determine a biocompatibility testing plan, development of chemical assessment, and preparation of test articles for devices containing submicron or nanotechnology components and comprised of polymerizing and/or absorbable materials.

Multiple Function Device Products: Policy and Considerations²

This guidance issued July 29, 2020, pertains to medical products with one or more device or “other” functions and addresses FDA’s policy for premarket review, including premarket submission content requirements, modifications to “other function” components and applicable post-market regulatory requirements. Through ISO 14971 (Medical devices -Application of risk management to medical devices), manufacturers must consider whether the “other function” components affect the safety or effectiveness of the device function and, if so, the extent to which risk could increase or performance could be adversely affected. FDA also recommends that the device and “other function” components be separated in their design and implementation in an effort to control risk for the device function.

Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway and Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway^{3, 4}

These two final guidance documents, issued August 14, 2020, are for specific device types appropriate for the Safety and Performance Based Pathway, which was clarified in FDA guidance (September 2019). These guidances specify the types of tests, testing methodology and acceptance criteria that 510(k) applicants should utilize to demonstrate substantial equivalence for their devices, in lieu of providing a performance-based comparison to a predicate device in their submissions. FDA intends to issue additional similar guidance for other device types eligible for this pathway.

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program⁵

This ASCA pilot program issued September 25, 2020, allows testing laboratories to obtain ISO 17025 accreditation so that manufacturers can utilize these laboratories to test devices to FDA-recognized standards and specifications in support of a future premarket submission. This program is intended to streamline the premarket review process by ensuring consistency in the use of standards and also to facilitate harmonization of medical device regulations internationally. In addition to the pilot program guidance, related guidances on biocompatibility⁶ and electrical safety/essential performance⁷ standards were issued, including how these standards are being included in the ASCA program.

Multiple Device-Specific Guidances for Breast Implants and Blood Glucose Meters

On September 29, 2020, the FDA issued the following guidance documents:

• Saline, Silicone Gel, and Alternative Breast Implants⁸
• Breast Implants - Certain Labeling Recommendations to Improve Patient Communication⁹
• Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use¹⁰
• Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use¹¹

¹ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and

² https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-device-products-policy-and-considerations

³ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cutaneous-electrodes-recording-purposes-performance-criteria-safety-and-performance-based-pathway

⁴ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conventional-foley-catheters-performance-criteria-safety-and-performance-based-pathway

⁵ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program

⁶ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme

⁷ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and

⁸ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants

⁹ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication

¹⁰ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-glucose-monitoring-test-systems-prescription-point-care-use

¹¹ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use