Hi RAPS Chicago Community,
Last night we had a very informative workshop on the CDRH's new Standards and Conformity Assessment Pilot Program presented by Simon Choi PhD, MPH. The ASCA draft guidance was issued on September 23rd, 2019 with a 90 day commentary period. If you are involved in premarket submissions to US FDA, you should make yourself familiar with this program. If you missed the workshop, FDA will also host a free webinar on October 28th, see the ASCA homepage for more details:
Accreditation Scheme for Conformity Assessment (ASCA)
| U.S. Food and Drug Administration |
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| Accreditation Scheme for Conformity Assessment (ASCA) |
| On September 20, 2019, the FDA issued a draft guidance entitled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff . The comment period is open under docket FDA-2019-D-3805 for 90 days. |
| View this on U.S. Food and Drug Administration > |
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Maria V. Vrabie
Director of Regulatory & Clinical Affairs
Abbott Rapid Diagnostics
Lake Forest, IL
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