img src="us-customers.png" alt="U.S. Testing Program"

New U.S. testing program for medical devices on trial

The U.S. authority FDA has, amongst other tasks, responsibility for the safety of marketed medical devices.

In order to allow for greater consistency and predictability in the FDA’s approach to conformity assessment, they have now set up a voluntary pilot accreditation program, which is denoted Accreditation Scheme for Conformity Assessment (ASCA)

Under this program, more than 50 testing laboratories have now been accredited to participate, including Nemko.
The ASCA program allows these accredited testing laboratories to assess medical devices for compliance with certain FDA-recognized standards.
The establishment of the ASCA was mandated under the 2017 FDA Reauthorization Act and is expected to provide increased confidence in the premarket testing results for such devices.

At present, 53 testing laboratories located in various countries, including Canada, Japan, Germany, Israel, South Korea and China as well as the U.S., are authorized to conduct testing to one or more FDA-recognized versions of standards and test methods included under the scope of the ASCA pilot.

A list of the laboratories involved can be seen here

The FDA is expected to continue to review and accredit additional testing laboratories and expand laboratory accreditations to include additional recognized standards during the pilot program.

For further information and/or assistance with testing of medical devices for the U.S. market, please contact Marilyn.Laroche@nemko.com 

Written by Trond Sollie
For more than 30 years, Sollie has worked with conformity assessment activities in various industrial contexts, both in Norway and internationally. He has been paramount in building relationships across organisations and borders. He has also been active in the management of the international IECEE/CB scheme for many years. Until recently, he was Board Chairman of the Norwegian standards body NEK and President of the Norwegian IEC National Committee and IECEE Member Body. He is currently an NEK Board Member and a member of the IEC-CAB (Conformity Assessment Board). He also provides consulting to authorities/bodies of several countries on conformity assessment matters. Nemko has benefitted from Sollie’s expertise, network and enthusiasm for more than three decades. Prior to his role as a senior advisor for Nemko, he was a Senior Vice President, responsible for international cooperation. He has been instrumental in developing the successful Nemko Direct programs that offer clients worldwide market access for their products, within both the electrical and telecommunications/radio product areas.

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