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Sec.
820.180 General requirements.
All records
required by this part shall be maintained at the manufacturing establishment
or other location that is reasonably accessible to responsible officials of
the manufacturer and to employees of FDA designated to perform inspections.
Such records, including those not stored at the inspected establishment,
shall be made readily available for review and copying by FDA employee(s).
Such records shall be legible and shall be stored to minimize deterioration
and to prevent loss. Those records stored in automated data processing
systems shall be backed up. (a) Confidentiality.
Records deemed confidential by the manufacturer may be marked to aid FDA in
determining whether information may be disclosed under the public information
regulation in part 20 of this chapter. Interpretation: It
is important to note that the FDA has an obligation to investigate an
organization’s documentation in order to make an assessment for
compliance. Withholding
information because of proprietary (or confidentiality) will not fly. Doing this can result in the
revoking of your licence. The
FDA may and usually refuse to sign ‘confidentiality’ agreements upon arriving
at your facility for an audit.
This is because they are required to disclose any information
pertaining to the safety and efficacy of your product. (b) Record
retention period. All records required by this part shall be retained for
a period of time equivalent to the design and expected life of the device,
but in no case less than 2 years from the date of release for commercial
distribution by the manufacturer. Interpretation:
This
can be tricky to estimate especially for products that are inserted into the
body. For instance a hip implant
can well remain inside a human body for decades. Given this requirement it is essential that all records
pertaining to the device is kept for this estimated time. (c) Exceptions.
This section does not apply to the reports required by § 820.20(c) Management
review, § 820.22 Quality audits, and supplier audit reports used to meet the
requirements of § 820.50(a) Evaluation of suppliers, contractors, and
consultants, but does apply to procedures established under these provisions.
Upon request of a designated employee of FDA, an employee in management with
executive responsibility shall certify in writing that the management reviews
and quality audits required under this part, and supplier audits where
applicable, have been performed and documented, the dates on which they were
performed, and that any required corrective action has been undertaken. Interpretation: Using the hip implant example above you wouldn’t be required to keep documentation that was produced as a result of management review or audits, etc. You would have to ensure you have a copy of the procedures that were used during the production of the device (same revision number, etc.).
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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