Drug Regulators, FDA, Publish Guidance on Selection of Accredited Persons.
Manufacturers Of Medical Devices May Be Eligible To Have Third-Party Inspections Of Their Establishments
On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the voluntary third-party inspection program initially established by law in 2002, and applicable to manufacturers of class II or class III medical devices who meet certain eligibility criteria (see 21 USC §374(g)). The Inspection by Accredited Persons Program (AP Program), allowed eligible manufacturers to elect to have third parties that have been accredited by FDA (Accredited Person or AP) conduct some of their inspections instead of FDA. Under that 2002 law, manufacturers of eligible medical devices requested prior approval to use an AP instead of FDA staff to conduct a Quality Systems (QS) regulation inspection of their facilities.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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