For many medical device manufacturers seeking FDA approval, consensus standards in pre-market submissions are not consistently applied; standards can be complex and can often require specialised knowledge to interpret and apply correctly. The FDA has proposed an Accreditation Scheme for Conformity Assessment (ASCA) Program using FDA-recognised consensus standards.
FDA intends to use this scheme to oversee the Conformity Assessment and ensure that there is appropriate interaction with parties that serve as Accrediting Bodies to accredit test laboratories. When a device using the ‘scheme’ is evaluated against a specific recognised standard by an accredited test laboratory, FDA intends to rely on the results from the accredited laboratory for the purpose of premarket review (i.e., generally accept that a device conforms with the standard) without the need to address further questions related to standards conformance.
This week the FDA asked stakeholders for input on its planned pilot scheme in an effort to boost device manufacturers’ ability to rely on conformity to recognised standards to support premarket submissions. The FDA plans to pilot the program by the end of 2020 and has agreed to develop draft guidance on accrediting, re-accrediting and suspending the accreditation of accreditation bodies and test labs by the end of 2019. In preparation, FDA is seeking feedback from stakeholders as to which standards should be included to ensure compliance, what impact they would like to see the program have, and what challenges related to consensus standards the agency should focus on during the pilot.
To access the full FDA request click here.