Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1W |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "openFDA",
"@type": "vcard:Contact",
"hasEmail": "mailto:open@fda.hhs.gov"
}
|
| description | A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. |
| distribution |
[
{
"@type": "dcat:Distribution",
"mediaType": "text/html",
"downloadURL": "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pmamemos.cfm"
}
]
|
| identifier | 8dabbf7e-0e4a-4e1c-a0d2-982d97398a10 |
| issued | 2021-02-25 |
| keyword |
[
"cdrh"
]
|
| landingPage | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pmamemos.cfm |
| license | http://opendefinition.org/licenses/odc-odbl/ |
| modified | 2025-07-16 |
| programCode |
[
"009:005"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes |
