The next section (Section 2.5) discusses the implications of these regulations for the software process. Unsurprisingly, given that most regulatory agencies are participants in the International Medical Device Regulators Forum (IMDRF), there is significant convergence in the regulations operating in different countries. After this, we survey related documents and agencies from the rest of the world (Section 2.4). We then review in detail some key FDA regulatory documents (Section 2.2) and provide an overview of the actual regulatory process (Section 2.3). We first describe the FDA itself (Section 2.1), including a brief history of how the current process has evolved over the past century. This chapter describes the regulatory process for medical software, with a particular emphasis on the documents issued by the United States Food and Drug Administration (FDA).
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Stanton and Offutt collaborated on 100s of original erotic comics and digest fiction, notably "Stantoons" and "Blunder Broad" digests, and were close friends who regularly corresponded through letters, photographs, story and art proofs, or sexy trinkets. Offutt, author of science-fiction, fantasy, and underground erotica, and a Stanton colleague. Very Good in Very Good plus jacket and slipcase light toning, brief stains, textblock detached at p142-43, w/o loose pages, jacket & slipcase lightly toned, foxing, prints lightly toned else Near Fine. Precedent for styles of Eric Stanton and the Klaw siblings. Reprints selections from Coutts' own magazine, Bizarre (1946-59), where he issued serial cartoons and photographs to subscribers, and reprinted several times. Illustrated adult erotic comics featuring bondage, female domination, bound women, riding crops, and dastardly captors. Quarto hardcover, 144pp, b/w/color throughout. 11 of 300 copies, with two numbered prints (7 x 10 inches), one by John Willie, the other by Eric Stanton, who has signed the print in holograph pencil, housed in printed folder affixed to the rear pastedown. First Edition, first print, a limited "deluxe" edition in original dust jacket and printed slipcase, no. The Adventures of Sweet Gwendoline (Limited Edition) Willie, John Allen Jones (forew.) Harry Benjamin (pref.) Eric Stanton (art) |
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