What to expect from x-ray device inspections
Device Regulation Alert: Safety, Compliance and Reimbursement News, June 9, 2008
Manufacturers of diagnostic x-ray systems must ensure their devices comply with the Electronic Product Radiation Control requirements of the Federal Food, Drug, and Cosmetic Act and don’t emit hazardous and unnecessary radiation.
FDA inspections monitor compliance and EPRC compliance inspections can be combined with medical device manufacturer inspections. Recent FDA guidance can help manufacturers understand what to expect from these inspections.
The guidance:
- Discusses how inspections will be carried out
- Includes a detailed list of the items that will be reviewed during the inspection such as:
- Documents and procedures regarding the manufacturing process
- Quality control testing procedures and records
- Records required by EPRC regulations
- Addresses how joint EPRC and medical device inspections and for cause inspections will be conducted
- Discusses regulatory enforcement options
The FDA may request recall of non-compliant devices and/or repair, replacement, or refunds devices. According to the guidance, EPRC violations include:
- Introducing defective or non-compliant products into the market
- Failing to keep or provide adequate reports and distribution records
- Failing to self-certify compliance of product
- Certifying a product falsely
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