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Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices Guidance for Industry and Food and Drug Administration Staff

Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices Guidance for Industry and Food and Drug Administration Staff

Regulatory Solutions
ipharmedservices   June 2, 2023  
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Assembler’s Guide to Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff

Assembler’s Guide to Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff

Regulatory Solutions
ipharmedservices   May 13, 2023  
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Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry

Regulatory Solutions
ipharmedservices   April 29, 2023  
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“Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff”

“Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff”

Regulatory Solutions
ipharmedservices   April 23, 2023  
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