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.
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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 |
