Variance from Manufacturer Report Number Format [MDR letter]

Description

CDRH has become aware of several problems or issues related to use of the proscribed format for the manufacturer report number that is to be used in submission of reports using FDA Form 3500A when the new MDR regulation becomes effective on July 31, 1996. The number consists of the FDA registration number of the manufacturing site, the four digit calendar year and a five digit sequence number that is to begin with 00001 for the first report submitted during a calendar year (Ref. 21 CFR 803.3(o)). The following types of problems have been noted:

Scope & Applicability

Regulatory Context

• 21CFR814.39§ 814.39 PMA supplements.

  (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →

• 21CFR814.20§ 814.20 Application.

  (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  Barkey GmbH & Co. KG

  2024-02-13

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