Overview:

The United States Food and Drug Administration released a final guidance on inspections of medical device establishments. The final guidance satisfies the requirement section 702(b)(2) of the FDA Reauthorization Act (FDARA) of 2017. As per Section 704(h)(1) of the FD&C Act, the FDA is requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments such as processes and standards through the adoption of uniform process and standards.

Guidance Key Points:

Pre-Announcement Inspections:

The pre-announcement inspections should occur within a “reasonable time”. Domestic inspections are pre-announced no less than 5 calendar days in advance. Foreign inspections are announced more than 5 calendar days to country clearances. Information included during domestic and foreign inspections are, type and nature of inspections, schedule of the inspection (surveillance or pre-approval).

Standard Inspection Timeframe:

FDA’s standard inspection timeframe is usually 3-6 business days, depending on the type of surveillance (abbreviated or comprehensive) and extend of coverage needed for inspections. Additionally, extension of an inspections could be necessary for several reasons, in such cases, the FDA should be notified with a verbal communication with appropriate timeframes.

Communication During Inspections:

 FDA’s updated process addresses verbal communication during the inspection between the investigator, owner, or agent in charge of the device establishment to minimize errors. The communication will not be documented in FDA Form 483 but will be recorded by the FDA or the firm.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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