Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program’s goals are to:
- streamline the conformity assessment in medical device submissions,
- enhance the FDA’s confidence in test methods and results,
- decrease the need for additional information related to conformance with a standard,
- promote consistency, predictability, and efficiency in medical device review,
- serve as a least burdensome approach to conformity assessment
The ASCA program’s final guidance documents, issued in 2020, set the current framework for the program:
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance (Program Guidance)
- Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)
- Biocompatibility Testing of Medical Devices – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)
The FDA grants ASCA accreditation to test labs that meet the requirements of the program. The ASCA test labs are authorized to conduct testing and the output from the lab is a summary report that the manufacturer submits to the FDA (more to come). Once the FDA approves an ASCA test lab the FDA identifies the scope of recognized consensus standards that the lab is able to test too (they are able to expand that list over time & the FDA may suspend any and all of the scope of the lab, if appropriate), the name & address of the lab and the ASCA contact on the ASCA test lab list. If the lab is suspended there seems to be a note in the current scope, there is no separate search feature on the db for active and suspended labs. I just sent in a request to the standards and conformity assessment (S-CAP) group that is in charge of this db to ask if they can make this more user friendly.
FDA has added standards to the list of approved standards beyond what is noted in both Standards Specific Final Guidance documents and plans to continue to add recognized consensus standards to the list/db. You can search the list of recognized consensus standards db but make sure you click the check box next to “Included in ASCA?” to view the list of standards that are included in the ASCA program. When you get to the link for a specific standard make sure you review the standard and see if any limitations on the standard if a partial or full recognition and also if there are any limits from the ASCA program perspective so you know what to expect. Then you need to make sure the test lab you are planning to use has the applicable standards in scope, that apply to the product that you want to test for your submission to the FDA.
You’ve chosen a test lab and gotten a test quote including the ASCA costs. Now you need to get the testing done but please make sure before you submit to the FDA you don’t have any comments on the summary report from the ASCA lab that aren’t positive towards the approval. If there are any issues you want to resolve them before a final report is issued from the test lab to the manufacturer. The manufacturer provides the summary report as part of the premarket submission, not the test lab. You want a clean summary report going to the FDA, as the FDA relies on the ASCA’s test lab summary report instead of the full test report that has been submitted in the past.
Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA, the ASCA program or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at or through our contact form.
We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.