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US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot

Regulatory Updates | Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has provided more information on its upcoming Accreditation Scheme for Conformity Assessment (ASCA) pilot program.
  • ASCA will include at least five FDA-recognized voluntary consensus standards for medical devices.
  • The pilot is expected to launch by September 2020.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).

CDRH’s ASCA Pilot Program, first announced in 2017,  was developed to reduce inconsistencies in testing practices, declarations of conformity and regulatory issues related to conformity assessments and medical device premarket reviews. Most recently, the regulator issued a Q&A list to flesh out details of the program.

How the ASCA pilot will work

The ASCA pilot will specify participation and performance requirements for accreditation bodies and testing labs involved in medical device conformity assessments, as well as conditions whereby such organizations would be suspended or withdrawn from the ASCA program.

FDA has yet to make a final determination as to which standards to include in the program, but has focused on areas including biological evaluation of medical devices as well as basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory equipment.

In accordance with requirements set by the Medical Device User Fee Amendments of 2017 (MDUFA IV), the ASCA pilot program will ultimately include at least five FDA-recognized consensus standards; the agency has not provided a specific date for announcing final determinations.

ASCA program timelines

US regulators plan to formally launch the ASCA pilot by September 30, 2020, and sunset the pilot on October 1, 2022 unless CDRH decides to make the program permanent.

Related US FDA medical device regulatory information:

  • US FDA 510(k) consulting for medical device and IVD companies
  • US FDA Pre-Sub consulting for medical device manufacturers
  • Medical device biocompatibility testing to ISO 10993
  • Whitepaper: Medical device testing requirements for 510(k) submissions
  • Whitepaper: ISO 10993-1 and biocompatibility for medical devices

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