How Will the US FDA’s ASCA Pilot Program Help You?

什么是ASCA试点计划?

The Accreditation Scheme for Conformity Assessment (ASCA) program is a voluntary pilot program intended to improve the efficiency of pre-market testing 和 certification of medical devices. It also provides manufacturers with confidence that their product is being tested by experts in their given field since the FDA has assessed this subset of test laboratories. 

该计划提供认证的, independent testing laboratories with the approval to assess medical devices for compliance with FDA-recognized st和ards. The FDA assumes a level of trust for the ASCA-approved testing laboratory 和, aside from regular quality audits, test results will not require further review to receive FDA approval, saving significant time in the process.

How will the ASCA Pilot Program benefit you, the manufacturer?

Medical device manufacturers who choose an FDA ASCA-accredited laboratory to conduct their test for pre-market submission can then use these results in their declaration of conformity (DOC). 

FDA表示, “testing performed by an ASCA-accredited testing laboratory can be used to support a pre-market submission for any device if the testing was conducted using an FDA-recognized consensus st和ard 和 test method eligible for inclusion in the ASCA Pilot 和 in accordance with the ASCA program specifications for that st和ard.” 

This means that the chance of FDA reviewers asking for additional review or repeat testing is very low with an ASCA-accredited test partner. The testing 和 review process is streamlined with an ASCA-accredited laboratory, providing consistency 和 predictability in your testing 和 review process. 

测试 with an FDA ASCA-accredited laboratory makes your testing process significantly more efficient, 让你穿梭一个保险箱, reliable 和 certified medical device to market quickly.

过程是怎样的??

1. Medical device manufacturers choose their ASCA-accredited laboratory for testing.

2. The laboratory then conducts required testing 和 provides the manufacturer with the information outlined in the applicable ASCA program.

3. The manufacturer then integrates the ASCA test report in their DOC for pre-market submission to the FDA. 

4. The FDA then assesses the application in line with their pre-market review

im体育APP如何提供帮助?

The initial list of ASCA-accredited testing laboratories was published on April 12, 2021, 和 we are pleased to say that im体育APP is among them. 

Our accredited laboratories perform electromagnetic compatibility (EMC) 和 wireless coexistence testing from five strategically positioned locations across the US. im体育APP’s accreditation covers all medical products governed by FDA regulations. We also help with the preparation of the test plan, an essential part of preparing for testing to ensure the right aspects are being tested 和 monitored correctly 和 in line with referenced st和ards.

im体育APP has a strong reputation for EMC, wireless coexistence 和 safety testing, 医疗器械认证, so combining these two capabilities, along with our broad geographical footprint, 转化为更好的交货时间. As we can combine medical device testing with all the other regulatory testing, such as FCC 和 CE标志 和 international certification schemes like IECEE CB, we can further shorten our customers’ time to market.

To learn more about our ASCA accreditation 和 medical device testing services, 或者开始测试过程, 请今天im体育APP.