Left to their own devices: breakdowns in United States medical device premarket review (Q33633943)

28 July 2017

1 reference

19 September 2019

Left to their own devices: breakdowns in United States medical device premarket review (English)

1 reference

biomedical investigative technique

28 July 2017

main subject

United States of America

0 references

1 reference

19 September 2019

1 reference

2

Peter Lurie

1 reference

28 July 2017

Jonas Zajac Hines

1

1 reference

28 July 2017

Eunice Yu

series ordinal

3

1 reference

28 July 2017

Sidney Wolfe

series ordinal

4

1 reference

28 July 2017

language of work or name

English

0 references

publication date

13 July 2010

2 references

28 July 2017

19 September 2019

2 references

28 July 2017

19 September 2019

7

1 reference

28 July 2017

issue

7

1 reference

28 July 2017

page(s)

e1000280

1 reference

Creative Commons Attribution 4.0 International

28 July 2017

copyright license

1 reference

Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices

19 September 2019

0 references

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

21 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial

21 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial.

21 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Medical device regulation: an introduction for the practicing physician

21 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark® Registry

21 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Elevated risk of pelvic inflammatory disease among women using the Dalkon Shield

21 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2903853

Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial

21 June 2018

1 reference

Crossref

https://api.crossref.org/works/10.1371%2FJOURNAL.PMED.1000280

Reply to Lisanby et al. Post hoc analysis does not establish effectiveness of rTMS for depression

21 January 2018

1 reference

Crossref

https://api.crossref.org/works/10.1371%2FJOURNAL.PMED.1000280

Order for transitional class III devices; submission of safety and effectiveness information under section 520(1)(5)(A) of the Federal Food, Drug, and Cosmetic Act--FDA. Notice

21 January 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/20634922

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

The limited state of technology assessment for medical devices: facing the issues

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/20634922

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1371/JOURNAL.PMED.1000280

1 reference

28 July 2017

1 reference

28 July 2017

1 reference