BioPractice

Real-Time Premarket Approval Application (PMA) Supplements
Friday, 15th November, 2019 01:00 PM IST 10:00 AM PST

An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical device. Premarket approval requirements apply differently to preamendments devices, postamendments devices.

• History of PMA regulations.
• When to file a PMA.
• Who must file a PMA .
• Preamendments devices and PMA requirements.
• Types of PMA submissions.
• Contents of a PMA.
• PMA review process.
• PMA user fees, review times, review trends
• Pitfalls and common mistakes
• Resources for more information

For More Information Kindly visit www.biopractice.com.
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